{"jobs":[{"absolute_url":"https://job-boards.greenhouse.io/oruka/jobs/5234891008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_optional","internal_job_id":4481802008,"location":{"name":"Menlo Park, California, United States"},"metadata":null,"id":5234891008,"updated_at":"2026-06-03T11:58:57-04:00","requisition_id":"113","title":"Accounting Manager","company_name":"Oruka Therapeutics","first_published":"2026-05-28T17:30:49-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Us:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit \u0026lt;a href=\u0026quot;http://www.orukatx.com\u0026quot;\u0026gt;www.orukatx.com\u0026lt;/a\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As we build our core team, we\u0026#39;re seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.\u0026amp;nbsp; Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. \u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Job Title:\u0026lt;/strong\u0026gt;\u0026amp;nbsp;Accounting Manager\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Location:\u0026lt;/strong\u0026gt;\u0026amp;nbsp;Menlo Park, CA.\u0026amp;nbsp; Hybrid – onsite 3 days/week is required.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Reports To\u0026lt;/strong\u0026gt;: Sr. Director, Controller\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;We are looking for a motivated and knowledgeable Accounting Manager to play a key role in accounting at a fast-paced public biotech company. Reporting to the Sr. Director, Controller, the Accounting Manager will be responsible for clinical trial accounting accruals and other accruals and prepaids. The ideal candidate will have a strong understanding of accruals of clinical trial costs in biotech industry, excellent analytical skills, and the ability to work effectively in a fast-paced environment.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026lt;u\u0026gt;Key Responsibilities:\u0026lt;/u\u0026gt;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Own end-to-end accrual processes for assigned clinical trials, including CRO fees, investigator grants, site costs, and pass-through expenses across various phases of clinical trials.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Partner with Clinical Operations, Clinical Outsourcing, and Program Management teams to obtain enrollment data, site milestones, and study activity required to develop and maintain robust accrual models and support accurate expense recognition under ASC 730.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Reconcile CRO and vendor reports and invoices against contracted budgets, accrued balances, and prepaid accounts; investigate and resolve variances.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaborate with FP\u0026amp;amp;A to interpret clinical trial agreements (CTAs), master service agreements (MSAs), statement of works (SOW) and amendments to ensure appropriate accounting treatment from contract execution through study close-out.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Prepare, review, and post journal entries for clinical accruals and other assigned ledger accounts, including other G\u0026amp;amp;A and R\u0026amp;amp;D accruals, prepaid expenses, etc. in accordance with US GAAP and company accounting policies.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Own assigned areas of accounting close tasks, perform and document monthly balance sheet reconciliations and resolve reconciling items promptly, ensuring timely and accurate completion within established deadlines.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support the external audit process and provide documentation and support for audit inquiries.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Maintain internal controls over clinical accrual accounting, including SOX documentation and testing procedures.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Identify opportunities to automate and scale assigned accounting workflows using AI or other tools.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Coordinate with internal and external stakeholders to gather and analyze financial data, supporting schedules.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Stay informed about changes in accounting standards and industry best practices, advising management on potential impacts and opportunities.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Assist with special projects and ad hoc financial reporting as needed.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026lt;u\u0026gt;Qualifications:\u0026lt;/u\u0026gt;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Bachelor\u0026#39;s degree in accounting, finance, or related field; CPA or equivalent certification preferred.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Minimum of 5-7 years of progressive accounting experience, with a minimum of 2–3 years directly focused on clinical trial accruals in a biotech, biopharma, or life sciences company.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated experience owning a monthly financial close process, including journal entry preparation, account reconciliations, and flux analysis.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Hands-on experience with clinical trial or R\u0026amp;amp;D accruals, including CRO and vendor expense management.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Exceptional organizational skills and ability to manage multiple concurrent clinical studies and close deadlines with accuracy and able to manage multiple priorities in a fast-paced environment.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proficiency with ERP systems (e.g., NetSuite, SAP, Oracle, Workday) and reconciliation tools (e.g. FloQast) and advanced Excel skills.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong knowledge of SOX 404 internal controls and experience maintaining control documentation in a public biotech environment.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent analytical and problem-solving skills, with the ability to interpret complex financial data and technical accounting guidance.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Compensation:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.\u0026amp;nbsp; The anticipated salary range for candidates is $146,000 - $161,000.\u0026amp;nbsp;The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;We\u0026#39;re looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Location:\u0026lt;/strong\u0026gt; Menlo Park, CA.\u0026amp;nbsp; Hybrid – onsite 3 days/week is required.\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Salary Range For the Role\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$146,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$161,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What We Offer:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Competitive salary and benefits package.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Opportunities for professional growth and development.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4017362008,"name":"Finance","child_ids":[],"parent_id":null}],"offices":[{"id":4008136008,"name":"Oruka Tx-Menlo Park","location":"Menlo Park, California, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/oruka/jobs/5194561008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_optional","internal_job_id":4462348008,"location":{"name":"Waltham, Massachusetts, United States"},"metadata":null,"id":5194561008,"updated_at":"2026-05-15T21:44:25-04:00","requisition_id":"88","title":"Administrative Assistant","company_name":"Oruka Therapeutics","first_published":"2026-04-20T17:06:06-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Us:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit \u0026lt;a href=\u0026quot;http://www.orukatx.com\u0026quot;\u0026gt;www.orukatx.com\u0026lt;/a\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As we build our core team, we\u0026#39;re seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.\u0026amp;nbsp; Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. \u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Job Title: Administrative Assistant\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Location: Waltham, MA / Onsite presence 2-3 days per week required\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Role Overview:\u0026lt;/strong\u0026gt; The Administrative Assistant will provide support to multiple team members across our medical and clinical operations groups. This role is well- suited for someone who thrives in a fast-paced, collaborative environment and enjoys balancing administrative and operational responsibilities. The ideal candidate is resourceful, able to anticipate needs, and comfortable adapting quickly as priorities shift.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Key Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Proactively manage complex, multi-time-zone calendars and provide day-to-day administrative support to multiple team members\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Coordinate domestic and international travel arrangements, including flights and accommodations\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Prepare and submit accurate, timely expense reports in accordance with company policies\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Assist with internal and external meeting logistics including greeting guests, catering, and materials as needed\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proactively manage kitchen inventory by stocking supplies and ensuring a clean, organized space\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Serve as the primary point of contact for vendors delivering office supplies and services, and monitor inventory levels, placing orders as needed to maintain appropriate stock.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Assist the Senior Executive Assistant with planning and executing internal events, offsites, and company gatherings\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Education and Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Bachelor’s degree or equivalent and 3+ years of administrative experience, preferably in biotech, healthcare, or a fast-paced environment\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong organizational skills with excellent attention to detail\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to manage multiple priorities and adapt to changing needs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proficiency with calendar management, expense reporting tools, and standard office software (e.g., Microsoft Office Suite, Google Workspace)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong communication and interpersonal skills\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to maintain confidentiality and professionalism\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Team player with a willingness to pitch in wherever needed\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Compensation: \u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;The anticipated salary range for candidates, who will work in \u0026lt;em\u0026gt;Waltham, MA \u0026lt;/em\u0026gt;is $28.00/hour to $35.00/hour.\u0026amp;nbsp;The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc.\u0026amp;nbsp;Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Position is hybrid, based in \u0026lt;em\u0026gt;Waltham, MA\u0026lt;/em\u0026gt;. Candidates will be required to be in-office 3 days/week.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;We\u0026#39;re looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Salary Range for the Role\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$28\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$35 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What We Offer:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Competitive salary and benefits package.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Opportunities for professional growth and development.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4017360008,"name":"Administrative","child_ids":[],"parent_id":null}],"offices":[{"id":4008137008,"name":"Oruka Tx-Waltham, MA","location":"Waltham, Massachusetts, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/oruka/jobs/5184889008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_required","internal_job_id":4457835008,"location":{"name":"Remote; Waltham, Massachusetts, United States"},"metadata":null,"id":5184889008,"updated_at":"2026-04-10T14:45:01-04:00","requisition_id":"85","title":"Associate Director / Director, Device Development (Prefilled Syringes \u0026 Auto-Injectors)","company_name":"Oruka Therapeutics","first_published":"2026-04-10T14:45:01-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Us:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit \u0026lt;a href=\u0026quot;http://www.orukatx.com\u0026quot;\u0026gt;www.orukatx.com\u0026lt;/a\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As we build our core team, we\u0026#39;re seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.\u0026amp;nbsp; Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. \u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Job Title: \u0026lt;/strong\u0026gt;Associate Director / Director, Device Development (Prefilled Syringes \u0026amp;amp; Auto-Injectors)\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Location: Hybrid – Waltham, MA\u0026lt;em\u0026gt;.\u0026lt;/em\u0026gt;\u0026lt;/strong\u0026gt; Candidates will be required to be in-office\u0026amp;nbsp;3 days/week.\u0026lt;strong\u0026gt; Remote may be considered.\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Position Summary\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;We are seeking an experienced and driven Associate Director or Director of Device Development to lead the end-to-end development of drug delivery systems, with a focus on prefilled syringes and auto-injectors for late-stage programs and commercialization.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This role will be responsible for integrating medical device engineering, human-centered design, and human factors engineering into combination product development, ensuring safe, effective, and patient-friendly delivery solutions. The ideal candidate brings deep expertise in biomedical engineering, device development, and regulatory requirements for combination products, along with a track record of advancing programs from clinical stages through commercial launch.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Key Responsibilities\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Device \u0026amp;amp; Combination Product Development\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Lead development of prefilled syringes, auto-injectors, and related delivery systems from late-stage clinical development through commercialization\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Define and execute device development strategies, including design, verification, validation, and lifecycle management\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Oversee combination product integration, ensuring alignment with CMC, clinical, and regulatory strategies\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Human-Centered Design \u0026amp;amp; Human Factors Engineering\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Drive human-centered product development, incorporating patient, caregiver, and healthcare provider needs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lead human factors engineering (HFE) activities, including use-related risk analysis, formative and summative (validation) studies\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure compliance with FDA, EMA, and global HFE/usability requirements\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Technical Leadership\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Provide subject matter expertise in biomedical engineering and device technologies\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lead cross-functional teams across development, clinical, regulatory, quality, and manufacturing\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Independently manage external partners, including device manufacturers, design firms, and testing laboratories\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;MSAT \u0026amp;amp; Manufacturing Support\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Provide MSAT leadership for device and combination product manufacturing across clinical and commercial stages\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Serve as Person-in-Plant (PIP) during manufacturing campaigns, ensuring on-site technical oversight and rapid issue resolution\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lead and support manufacturing campaigns, including engineering runs, clinical, PPQ, and commercial production\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Partner with CMOs and internal teams to ensure robust manufacturing processes, tech transfer, and scale-up\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Drive investigations, deviations, CAPAs, and continuous process improvements related to device and combination product manufacturing\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Regulatory \u0026amp;amp; Quality\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Support regulatory submissions (e.g., IND, BLA) with device-related content\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure compliance with combination product regulations (21 CFR Part 4, ISO 13485, IEC 62366, ISO 14971)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Partner with Quality to ensure design controls and risk management processes are implemented effectively\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Qualifications\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Education\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;PhD, or MS in Biomedical Engineering, Mechanical Engineering, or related field\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Experience\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Associate Director: 8+ years of relevant experience\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Director: 12+ years of relevant experience\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Significant experience in combination products and drug delivery devices, particularly prefilled syringes and/or auto-injectors\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proven track record supporting late-stage development and commercialization\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Technical Expertise\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Strong knowledge of:\u0026lt;/li\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Medical device design and development processes\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Human factors engineering / usability engineering\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Risk management\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Design controls and validation requirements\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;MSAT and manufacturing support for combination products\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;li\u0026gt;Experience with biologics delivery systems preferred\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Leadership \u0026amp;amp; Collaboration\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated ability to lead cross-functional, matrixed teams\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong communication skills with experience influencing senior leadership and external partners\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strategic mindset with the ability to balance technical depth and business objectives\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Preferred Qualifications\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Experience with regulatory interactions (FDA, EMA) for combination products\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Background in patient-centric design\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with commercial device manufacturing and supply chain management\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Additional Requirements\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Ability to travel up to 20%, including visits to manufacturing sites, external partners, and testing facilities\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Compensation:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;The anticipated salary range for candidates, who will work in Waltham, MA is $182,000-208,000 for Associate Director and $213,000-240,000 for Director. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;We\u0026#39;re looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Salary Range for the Role\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$182,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$240,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What We Offer:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Competitive salary and benefits package.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Opportunities for professional growth and development.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4017352008,"name":"CMC","child_ids":[],"parent_id":null}],"offices":[{"id":4008137008,"name":"Oruka Tx-Waltham, MA","location":"Waltham, Massachusetts, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/oruka/jobs/5184329008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_required","internal_job_id":4457665008,"location":{"name":"Waltham, Massachusetts, United States"},"metadata":null,"id":5184329008,"updated_at":"2026-06-01T19:12:58-04:00","requisition_id":"82","title":"Clinical Trial Manager/Senior Clinical Trial Manager","company_name":"Oruka Therapeutics","first_published":"2026-04-10T17:04:33-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Us:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit \u0026lt;a href=\u0026quot;http://www.orukatx.com\u0026quot;\u0026gt;www.orukatx.com\u0026lt;/a\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As we build our core team, we\u0026#39;re seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.\u0026amp;nbsp; Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. \u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Job Title:\u0026amp;nbsp;\u0026lt;/strong\u0026gt;Clinical Trial Manager/Senior Clinical Trial Manager\u0026amp;nbsp; \u0026amp;nbsp; \u0026amp;nbsp;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026amp;nbsp; \u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Location: \u0026lt;/strong\u0026gt;Hybrid 3 days/week if located near office in Waltham, MA or Menlo Park,\u0026lt;em\u0026gt; CA\u0026lt;/em\u0026gt; will be required.\u0026amp;nbsp; Remote may be considered.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Us:\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit\u0026amp;nbsp;\u0026lt;a href=\u0026quot;http://www.orukatx.com/\u0026quot;\u0026gt;www.orukatx.com\u0026lt;/a\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As we build our core team, we\u0026#39;re seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.\u0026amp;nbsp; Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. \u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Role Overview:\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Will ensure trial compliance, regulatory alignment, and operational efficiency while collaborating with cross-functional teams to advance Oruka\u0026#39;s clinical pipeline. \u0026amp;nbsp;Independently manage the clinical trial by effectively planning and executing the study to ensure quality of deliverables within the specified budget and timeframe. May serve as the clinical functional lead and lead clinical trial initiatives for Oruka\u0026#39;s cutting-edge dermatology treatments.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Key Responsibilities:\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Clinical Trial Management:\u0026lt;/li\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Lead and manage multiple clinical trials from initiation through to completion, ensuring adherence to study timelines and budgets.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaborate with investigators, vendors, and cross-functional teams to ensure study execution and operational excellence.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Oversee the preparation and review of trial-related documentation, including protocols, informed consent forms (ICFs), case report forms (CRFs), and study reports.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;In partnership with Program Management, develop and drive cross functional study timelines related to trial setup and execution.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;li\u0026gt;Team Leadership:\u0026lt;/li\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Drive the cross functional internal study team ensuring appropriate alignment, risk management and coordination across all participating functions.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Successfully interface with Data Management, Biostatistics and Clinical Development to ensure seamless monitoring and data cleaning initiatives to meet study deliverables and timelines\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Foster a collaborative team environment focused on operational efficiency and continuous improvement.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;li\u0026gt;Regulatory and Compliance Oversight:\u0026lt;/li\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Ensure that clinical trials are conducted in compliance with all applicable regulations, including FDA, EMA, and ICH-GCP guidelines.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support the preparation and submission of clinical trial applications, including INDs, NDAs, and other regulatory documents with functional leads.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Manage interactions with Regulatory Affairs and external vendors to ensure timely submissions and approvals.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;li\u0026gt;Budget and Resource Management:\u0026lt;/li\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Develop and manage clinical trial budgets, ensuring efficient use of resources and timely financial reporting.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Monitor and control trial costs to ensure alignment with project forecasts and company objectives.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Negotiate contracts and budgets with clinical vendors and investigators.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;li\u0026gt;Vendor and Site Management:\u0026lt;/li\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Oversee the selection and management of clinical vendors (CROs, laboratories, etc.) and ensure they meet performance expectations.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Develop strong relationships with clinical sites and external partners to ensure aggressive site startup, high-quality data collection and trial conduct.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Perform risk assessment and management, addressing issues proactively to mitigate operational issues.\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Bachelor’s or Master’s degree in life sciences or a related field.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;5-7+ years of experience in clinical operations, with a focus on managing complex clinical trials.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Expertise in GCP and regulatory requirements.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong leadership and team management skills.\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Compensation:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;The anticipated salary range for Manager level is $146,000 - $161,000 and Sr. Manager level is $161,000 - $187,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Job Location:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;\n\u0026lt;p\u0026gt;Hybrid 3 days/week if located near office in Waltham, MA or Menlo Park, CA will be required.\u0026amp;nbsp; Remote may be considered.\u0026lt;/p\u0026gt;\n\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;We\u0026#39;re looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Salary Range for the Role\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$146,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$187,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What We Offer:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Competitive salary and benefits package.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Opportunities for professional growth and development.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4017355008,"name":"Clinical Operations","child_ids":[],"parent_id":null}],"offices":[{"id":4008137008,"name":"Oruka Tx-Waltham, MA","location":"Waltham, Massachusetts, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/oruka/jobs/5184631008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_required","internal_job_id":4457815008,"location":{"name":"Remote; Waltham, Massachusetts, United States"},"metadata":null,"id":5184631008,"updated_at":"2026-06-02T04:24:38-04:00","requisition_id":"84","title":"Director, Analytical Development and Validation, Tech Ops (Biologics)","company_name":"Oruka Therapeutics","first_published":"2026-04-10T14:45:54-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Us:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit \u0026lt;a href=\u0026quot;http://www.orukatx.com\u0026quot;\u0026gt;www.orukatx.com\u0026lt;/a\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As we build our core team, we\u0026#39;re seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.\u0026amp;nbsp; Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. \u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;hr\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Job Title: \u0026lt;/strong\u0026gt;Director, Analytical Development and Validation, Tech Ops (Biologics)\u0026lt;strong\u0026gt;\u0026amp;nbsp; \u0026amp;nbsp; \u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Location: \u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;Hybrid – Waltham, MA\u0026lt;em\u0026gt;.\u0026lt;/em\u0026gt;\u0026lt;/strong\u0026gt; Candidates will be required to be in-office\u0026amp;nbsp;3 days/week.\u0026lt;strong\u0026gt; Remote may be considered.\u0026amp;nbsp; \u0026amp;nbsp; \u0026amp;nbsp; \u0026amp;nbsp;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Role Overview:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Director of Analytical Development and Validation will provide scientific and strategic leadership for late-stage analytical activities supporting the development, validation, and lifecycle management of biologic drug products, with a focus on monoclonal antibodies. This role will lead method validation and comparability efforts in support of BLA/MAA submissions, process changes, and commercial readiness, while partnering closely with CMC, Quality, Regulatory Affairs, and external partners.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The ideal candidate is a hands-on leader with deep expertise in analytical method validation, device functional testing, regulatory expectations for late-stage biologics, and the ability to guide teams through complex technical and compliance-driven milestones. This role is highly visible within the CMC team and a pivotal addition to our growing organization where you will play an integral role in supporting multiple programs’ analytical activities in support of releasing supplies for clinical trials and preparing for commercialization across US, Canada and EU.\u0026lt;/p\u0026gt;\n\u0026lt;h1\u0026gt;\u0026lt;span style=\u0026quot;font-size: 12pt;\u0026quot;\u0026gt;\u0026lt;u\u0026gt;Key Responsibilities:\u0026lt;/u\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;/h1\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Lead late-stage analytical development activities for biologics, including method transfer \u0026amp;amp; validation for release, stability, characterization and device functional testing assays.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide subject matter expertise for ICH Q2/Q14, USP/EP/JP, and global regulatory expectations related to analytical methods.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Oversee validation of assays including potency/bioassays, purity and impurities (SEC, CE-SDS, icIEF, HPLC), identity, characterization, residuals and device functional testing.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with PFS and Autoinjector functional testing is required, including validation per ISO guidance(s).\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Drive analytical strategies to support BLA/MAA submissions, post-approval changes, and comparability studies.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Partner with Process Development, Manufacturing, Quality, and Regulatory to support late-stage development, tech transfer, and commercial launch readiness.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support analytical risk assessments, control strategy development, and lifecycle management activities.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Serve as analytical lead for regulatory interactions, including agency questions and inspections.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Build, mentor, and lead a high-performing analytical development team (internal and/or external).\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Set technical direction, priorities, and timelines for late-stage analytical deliverables.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Manage and provide technical oversight to CDMOs and contract laboratories.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Review and approve protocols, validation reports, development reports, and regulatory documentation.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;10-20% travel is required for this role.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;h1\u0026gt;\u0026lt;span style=\u0026quot;font-size: 12pt;\u0026quot;\u0026gt;\u0026lt;u\u0026gt;Qualifications:\u0026lt;/u\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;/h1\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Experience with monoclonal antibodies and PFS/Auto Injectors is a requirement.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Director: Master’s (10+ years) or PhD (7+ years) with experience in a scientific discipline with relevant experience in analytical development and/or QC.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Relevant industry experience in method development, qualification, validation and method transfer in support of ongoing development and/or commercialization of biologics.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with methods including but not limited to U/HPLC, Capillary Electrophoresis, Spectrophotometer, Bioassay (ELISA and Cell-Based), device functional testing per ISO guidance.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Deep understanding of ICH guidelines for method development/qualification and validation as well as regulatory expectations in US, Canada and EU.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience managing multiple stability studies, protocol development and performing trending analysis, OOS/OOT investigations, root cause analysis, etc.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with late-phase comparability studies, especially geared toward commercialization.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience in authoring/contributing to regulatory filings, specifically Module 3 for analytical methods and stability studies\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated track record of successful tech transfers between CDMOs with an eye towards late-stage development and commercial launch.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent writing, organization, communication and people management skills with the ability to work effectively with a diverse group of internal and external stakeholders.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Must have a creative and strategic attitude with the ability to work in a fast-paced environment.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Compensation:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;The anticipated salary range for candidates, who will work in Waltham, MA is $213,000-240,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;We\u0026#39;re looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Salary Range for the Role\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$213,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$240,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What We Offer:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Competitive salary and benefits package.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Opportunities for professional growth and development.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4017352008,"name":"CMC","child_ids":[],"parent_id":null}],"offices":[{"id":4008137008,"name":"Oruka Tx-Waltham, MA","location":"Waltham, Massachusetts, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/oruka/jobs/5236397008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_optional","internal_job_id":4482381008,"location":{"name":"Menlo Park, California, United States; Remote; Waltham, Massachusetts, United States"},"metadata":null,"id":5236397008,"updated_at":"2026-06-05T12:58:21-04:00","requisition_id":"115","title":"Director, Clinical Monitoring Strategy","company_name":"Oruka Therapeutics","first_published":"2026-05-29T18:19:55-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Us:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit \u0026lt;a href=\u0026quot;http://www.orukatx.com\u0026quot;\u0026gt;www.orukatx.com\u0026lt;/a\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As we build our core team, we\u0026#39;re seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.\u0026amp;nbsp; Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. \u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Job Title:\u0026amp;nbsp;\u0026amp;nbsp;\u0026amp;nbsp;\u0026amp;nbsp;\u0026amp;nbsp;\u0026amp;nbsp;\u0026amp;nbsp;\u0026amp;nbsp;\u0026amp;nbsp;\u0026amp;nbsp;\u0026amp;nbsp; Director, \u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;Clinical Monitoring Strategy and Optimization\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Location: \u0026amp;nbsp;\u0026lt;/strong\u0026gt;Remote or Waltham, MA or Menlo Park, CA,\u0026amp;nbsp; Hybrid – onsite up to 3 days/week is required when not traveling.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Role Overview:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;We are seeking an experienced and highly motivated Director of Clinical Monitoring Strategy and Optimization to provide strategic and operational leadership for clinical monitoring activities across our development programs. This individual will play a critical role in building and scaling clinical operations infrastructure within a fast-paced emerging biotech environment.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The successful candidate will oversee CRO monitoring performance, ensure high-quality execution of clinical trials, and contribute to the development of monitoring processes, vendor oversight strategies, and inspection readiness activities. This role requires a hands-on leader who is comfortable operating both strategically and tactically in a lean organization.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This role will involve extensive regional and national/international travel (up to 80%) to clinical sites and vendors as needed to support training, study visits, oversight of staff and relationship building.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Key Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;Clinical Monitoring Leadership and Oversight\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;Lead and oversee clinical monitoring activities for Phase 1–3 clinical trials conducted globally and/or domestically.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Serve as the internal expert for monitoring strategy, site management, and risk-based monitoring approaches.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide oversight and management of all vendors involved with clinical monitoring to ensure quality, timelines, and budget adherence.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Develop metrics to oversee monitoring progress including central monitoring performance and protocol deviation management.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Trial Execution and Compliance\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;Drive the development of the clinical monitoring plan, annotated monitoring visit reports and all training materials for CRAs.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Identify Key Risk indicators for studies at the investigative site level and their associated oversight.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Contribute to inspection readiness activities and support regulatory inspections and audits.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Participate in or lead Site Qualification or Initiation visits as needed to build site relationships and monitor CRA performance.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Operational Process Development\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Help build scalable clinical monitoring infrastructure appropriate for a growing biotech company.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Develop and refine SOPs, work instructions, templates, and monitoring processes.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Drive continuous improvement initiatives focused on quality, efficiency, and operational excellence.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Implement and optimize risk-based monitoring methodologies and centralized monitoring approaches where appropriate.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Team Leadership and Mentorship\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;May directly manage CRAs and/or Clinical Trial Managers as the organization grows.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Mentor junior clinical operations staff and contribute to team development.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Foster a collaborative, accountable, and quality-focused culture.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Required\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Bachelor’s degree in life sciences, nursing, or related discipline.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;10+ years (Director) of clinical operations experience within biotech, pharmaceutical, or CRO environments.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Significant experience overseeing clinical monitoring activities in interventional clinical trials.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Capable of presenting and training audiences of varied backgrounds, including PIs, Sub-Is, Study Coordinators and other site staff.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience managing CROs and external vendors.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated ability to work effectively in a small, fast-moving biotech environment.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent communication, organizational, and problem-solving skills.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Extensive domestic and international travel as needed (approximately 60-80%).\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Preferred\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Bachelor’s degree or equivalent required.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Advanced degree (MS, MPH, PharmD, PhD, or RN) preferred.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience in immunology, dermatology, rheumatology, or oncology.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience supporting NDA/BLA-enabling studies and regulatory inspections.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience implementing risk-based monitoring strategies and oversight models.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Prior people management experience.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strategic thinker with strong execution skills\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Comfortable with ambiguity and rapid change\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Hands-on and solutions-oriented\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong collaborator and relationship builder\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;High attention to detail and commitment to quality\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to influence cross-functional teams and external partners\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Compensation:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;The anticipated salary range for candidates is $213,000 - $240,000.\u0026amp;nbsp;The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc.\u0026amp;nbsp;\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Location: \u0026amp;nbsp;\u0026lt;/strong\u0026gt;Remote or Waltham, MA or Menlo Park, CA,\u0026amp;nbsp; Hybrid – onsite up to 3 days/week is required when not traveling.\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Salary Range for the Role\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$213,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$240,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What We Offer:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Competitive salary and benefits package.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Opportunities for professional growth and development.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4017355008,"name":"Clinical Operations","child_ids":[],"parent_id":null}],"offices":[{"id":4008136008,"name":"Oruka Tx-Menlo Park","location":"Menlo Park, California, United States","child_ids":[],"parent_id":null},{"id":4008137008,"name":"Oruka Tx-Waltham, MA","location":"Waltham, Massachusetts, United States","child_ids":[],"parent_id":null},{"id":4014100008,"name":"Remote","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/oruka/jobs/5236048008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_optional","internal_job_id":4482363008,"location":{"name":"Waltham, Massachusetts, United States"},"metadata":null,"id":5236048008,"updated_at":"2026-06-03T11:56:34-04:00","requisition_id":"114","title":"Director, Clinical Operations","company_name":"Oruka Therapeutics","first_published":"2026-05-29T15:31:16-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Us:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit \u0026lt;a href=\u0026quot;http://www.orukatx.com\u0026quot;\u0026gt;www.orukatx.com\u0026lt;/a\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As we build our core team, we\u0026#39;re seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.\u0026amp;nbsp; Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. \u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Job Title:\u0026lt;/strong\u0026gt;\u0026amp;nbsp;Director, Clinical Operations\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Location:\u0026lt;/strong\u0026gt; Waltham, MA\u0026amp;nbsp;\u0026amp;nbsp;\u0026lt;strong\u0026gt;Hybrid – onsite 3 days/week required\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Reports To\u0026lt;/strong\u0026gt;: Vice President, Clinical Operations\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Role Overview:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;We are seeking an exceptionally nimble and flexible Director of Clinical Operations who has a track record of achievement across all aspects of trial setup and execution in a fast paced small biotech with limited infrastructure and resources.\u0026amp;nbsp; The individual will successfully lead and optimize activity across multiple studies for Oruka Therapeutics. This critical role demands a strategic leader who possesses a keen ability to \u0026quot;zoom in\u0026quot; on intricate operational details while simultaneously \u0026quot;zooming out\u0026quot; to maintain a holistic view of program progress and timelines\u0026lt;strong\u0026gt;.\u0026lt;/strong\u0026gt; The successful candidate will be a proactive problem-solver, adept at navigating complexities, anticipating challenges, and implementing agile solutions to ensure our clinical trials remain on schedule and within budget. We are looking for a candidate that can demonstrate a high degree of integrity, pragmatism and is laser focused on commitment to study goals.\u0026amp;nbsp; You should be comfortable being a ‘player/coach’ taking on tactical tasks as required in support of the program.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Key Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Strategic Oversight \u0026amp;amp; Agility in Clinical Study Planning, Management and Execution:\u0026lt;/li\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Develop and implement strategic operational plans for clinical trials, ensuring alignment with program goals and business objectives.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proactively identify potential risks, bottlenecks, and deviations from timelines, and swiftly implement corrective actions with a flexible and adaptable approach.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrate the ability to rapidly assess evolving circumstances (e.g., regulatory changes, unexpected site challenges, vendor issues) and adjust operational strategies accordingly.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Maintain a high-level overview of all assigned clinical trials, understanding interdependencies and potential impacts on overall program timelines.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;li\u0026gt;Operational Excellence \u0026amp;amp; Detailed Focus in Conducting Clinical Trials:\u0026lt;/li\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Provide expert operational guidance and oversight for all phases of clinical trials, from study startup through close-out.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Possess the ability to delve into granular operational details when necessary to identify root causes and inform strategic decisions.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure adherence to Good Clinical Practice (GCP), regulatory requirements, Standard Operating Procedures (SOPs), and company policies.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Oversee the selection, qualification, and management of Contract Research Organizations (CROs) and other third-party vendors, ensuring their performance meets expectations and timelines.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Maintain oversight of clinical operations budgets, including regular forecasting and internal reporting to management and finance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support supply chain planning and management with both clinical and non-clinical supplies for trial execution.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;li\u0026gt;Timeline Management \u0026amp;amp; Proactive Problem Solving in Executing Clinical Trial Programs:\u0026lt;/li\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Lead and manage clinical trial timelines, ensuring key milestones are met and proactively mitigating any delays.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Implement robust tracking and reporting mechanisms to monitor trial progress and identify potential deviations early.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Develop and execute contingency plans to address unforeseen challenges and keep trials on track.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Facilitate effective communication and collaboration across cross-functional teams to drive trial progression.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;li\u0026gt;Operate as a “Hands-On” Leader \u0026amp;amp; Develop Teams in a Fast-Paced Environment:\u0026lt;/li\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;We need a \u0026lt;strong\u0026gt;hands-on leader who can contribute individually to deliverables and meet deadlines\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt; t\u0026lt;/strong\u0026gt;o hit ORUKA milestones.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Foster a culture of accountability, continuous improvement, and proactive problem-solving within the clinical operations group.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Represent Clinical Operations in internal and external meetings, contributing to strategic discussions and decision-making.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;BA/BS required in a scientific/medical field preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A minimum of 10+ years of experience in managing global clinical trials at all stages of development\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience in immunological and dermatologic disease areas welcome\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Capable of managing direct reports from afar and study team members across multiple time zones and cultures\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated ability to successfully manage and deliver clinical trials from start-up through close-out, including all financial tracking and reporting activities\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated successful management and oversight of CROs and other service providers\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Deep understanding of clinical trial design, protocol development/ review, and running the clinical trial meetings\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Significant experience with cross-functional leadership and clinical teams, including leading data review, protocol deviation review, database lock, CSR development, and study reporting activities\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong vendor management experience required\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience in the management and maintenance of EDC, CTMS, IRT, ePRO, etc.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with Quality Assurance, SOP and Study Plans writing, CAPA preparation, and closure\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with a submission-ready eTMF, regulatory inspections and/or inspection-readiness activities\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong knowledge of GCP and working knowledge in ICH GCP E6 R2 regulations\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong project management experience and skills is preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrate strong leadership, collaboration and cross-functional management skills, ability to multi-task in a dynamic and fast-paced environment\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong interpersonal, negotiation, influencing, problem-solving skills\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent written and verbal skills required\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Willing to travel domestically and internationally up to 25% of the time\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong computer and database skills\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Clear and concise oral and written communication skills\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent organizational skills and experience prioritizing conflicting demands\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Critical thinking, problem solving, ability to work independently.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Consistently operate with urgency, clarity and conciseness\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Communicate effectively and articulate complex ideas in an easily understandable way\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Compensation:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;The anticipated salary range for candidates is $213,000 - $240,000.\u0026amp;nbsp;The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc.\u0026amp;nbsp;\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Location:\u0026lt;/strong\u0026gt; Waltham, MA\u0026amp;nbsp; Hybrid – onsite 3 days/week required\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Salary Range for the Role\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$213,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$240,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What We Offer:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Competitive salary and benefits package.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Opportunities for professional growth and development.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4017355008,"name":"Clinical Operations","child_ids":[],"parent_id":null}],"offices":[{"id":4008136008,"name":"Oruka Tx-Menlo Park","location":"Menlo Park, California, United States","child_ids":[],"parent_id":null},{"id":4008137008,"name":"Oruka Tx-Waltham, MA","location":"Waltham, Massachusetts, United States","child_ids":[],"parent_id":null},{"id":4014100008,"name":"Remote","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/oruka/jobs/5182408008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_required","internal_job_id":4456990008,"location":{"name":"Waltham, Massachusetts, United States"},"metadata":null,"id":5182408008,"updated_at":"2026-04-09T12:29:12-04:00","requisition_id":"81","title":"Director, Clinical Quality Assurance","company_name":"Oruka Therapeutics","first_published":"2026-04-09T12:29:12-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Us:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit \u0026lt;a href=\u0026quot;http://www.orukatx.com\u0026quot;\u0026gt;www.orukatx.com\u0026lt;/a\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As we build our core team, we\u0026#39;re seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.\u0026amp;nbsp; Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. \u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Job Title: \u0026lt;/strong\u0026gt;Director, Clinical Quality Assurance\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Location: \u0026lt;/strong\u0026gt;Remote; Waltham, MA area candidates preferred.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Role Overview:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Director, Clinical Quality Assurance is responsible for providing strategic quality leadership, support, and oversight for Oruka’s clinical development activities, with primary focus on Good Clinical Practice (GCP) and related quality systems supporting clinical trials. This role will establish, improve, and lead phase-appropriate clinical quality processes, ensure robust oversight of clinical trial execution and vendor performance, and drive inspection readiness for global health authority inspections, including FDA Bioresearch Monitoring (BIMO) inspections.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This role will partner closely with Clinical Operations, Clinical Development, Biometrics, Pharmacovigilance, Regulatory Affairs, Medical Writing, and external service providers to ensure that clinical studies are conducted in accordance with GCP, applicable global regulations, internal procedures, and protocol requirements. The Director, Clinical QA will provide proactive quality input across the clinical trial lifecycle, support continuous improvement, and help build a quality-focused culture as the organization advances its pipeline.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;Key Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;em\u0026gt;Clinical Quality Oversight\u0026lt;/em\u0026gt;: Provide Clinical QA oversight for new and ongoing clinical studies to ensure compliance with GCP, applicable regulatory requirements, and internal procedures. Serve as the primary quality business partner to Clinical Operations and other development functions to identify, assess, and mitigate quality and compliance risks across the clinical trial lifecycle. Review key study-level documents for quality and compliance, including protocols, informed consent forms, investigator brochures, monitoring plans, vendor oversight plans, data review plans, study reports, and essential trial documentation. Support development and implementation of phase-appropriate clinical quality procedures and processes.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;em\u0026gt;Quality Systems Support for Clinical Development\u0026lt;/em\u0026gt;: Provide quality support for clinical deviations, protocol deviations, investigations, root cause analysis, CAPA development, effectiveness checks, and change control activities related to clinical development. Ensure appropriate escalation, documentation, trending, and management visibility for significant quality issues. Partner cross-functionally to identify recurring themes, systemic risks, and opportunities for process improvement. Establish and maintain clinical quality metrics and dashboards to support management review and continuous improvement.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;em\u0026gt;Vendor and CRO Quality Oversight\u0026lt;/em\u0026gt;: Provide quality oversight of CROs, central laboratories, clinical software vendors, and other GCP-relevant service providers supporting Oruka’s clinical programs. Support qualification, selection, ongoing oversight, and performance evaluation of GCP vendors, including participation in vendor audits or due diligence activities as needed. Contribute to vendor governance processes to ensure appropriate quality expectations, responsibilities, and issue escalation pathways are defined and maintained.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;em\u0026gt;Audit Program Execution\u0026lt;/em\u0026gt;: Develop and execute a phase-appropriate GCP audit strategy and annual audit program based on risk, program priorities, and business needs. Conduct and/or manage investigator site, vendor, study-specific, and for-cause audits as needed. Author audit plans, reports, observations, and follow-up actions, and ensure timely resolution of audit findings through appropriate CAPA management and verification of effectiveness. Travel to clinical sites, vendors, and investigator meetings as needed.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;em\u0026gt;Inspection Readiness and Health Authority Support:\u0026lt;/em\u0026gt; Lead GCP inspection readiness activities across the organization, including development of inspection readiness plans, mock inspections, storyboards, SME preparation, document review, and inspection response coordination. Serve as the primary Clinical QA lead for FDA BIMO inspection readiness and support for other global regulatory inspections involving clinical trial activities. Partner with internal teams and external vendors to ensure inspection-facing documentation, processes, and responsibilities are inspection-ready at all times.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;em\u0026gt;Risk-Based Quality Management:\u0026lt;/em\u0026gt; Embed risk-based quality management principles into study oversight and clinical quality processes. Partner with Clinical Operations and cross-functional teams to support quality risk assessments, critical data/process identification, quality tolerance considerations where appropriate, and evaluation of key risk indicators and centralized quality signals. Ensure quality oversight activities are focused on matters most relevant to subject safety, rights, data integrity, and trial reliability.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;em\u0026gt;Inspection-Ready Documentation and TMF Support: \u0026lt;/em\u0026gt;Provide quality support and oversight related to Trial Master File (TMF) health, inspection-ready documentation practices, and completeness of essential records. Collaborate with study teams and vendors to ensure that documentation standards, reconciliation processes, and issue escalation practices support an inspection-ready state throughout study conduct.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Minimum Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related discipline; advanced degree preferred.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;10+ years of experience in Clinical QA/GCP Quality within biotechnology, pharmaceuticals, or a CRO environment.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong knowledge of GCP and applicable global clinical regulatory requirements.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience supporting quality oversight for Phase 1–3 clinical trials.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated experience with GCP audits, including investigator site and/or vendor audits.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience supporting clinical deviations, investigations, CAPAs, and related quality system activities.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience leading or supporting inspection readiness and regulatory inspections, including FDA BIMO inspections.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong working knowledge of sponsor oversight expectations for CROs and other outsourced clinical vendors.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent judgment, communication, and collaboration skills, with the ability to influence across functions in a fast-paced environment.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Willingness to travel as needed for audits, site visits, and inspection readiness activities (10-15%).\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Preferred Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Experience as an early Clinical QA hire in a growing biotech company.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience supporting biologics development programs.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Familiarity with eQMS tools and clinical systems relevant to quality oversight.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with risk-based quality management and quality metrics.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Compensation:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;The anticipated salary range for candidates is $213,000 - $240,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc.\u0026amp;nbsp;Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;Job Location:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Remote; Waltham, MA candidates preferred\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;We\u0026#39;re looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Salary Range for the Role\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$213,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$240,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What We Offer:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Competitive salary and benefits package.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Opportunities for professional growth and development.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4017356008,"name":"Quality","child_ids":[],"parent_id":null}],"offices":[{"id":4008137008,"name":"Oruka Tx-Waltham, MA","location":"Waltham, Massachusetts, United States","child_ids":[],"parent_id":null},{"id":4014100008,"name":"Remote","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/oruka/jobs/5234842008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_optional","internal_job_id":4481766008,"location":{"name":"Menlo Park, California, United States; Remote; Waltham, Massachusetts, United States"},"metadata":null,"id":5234842008,"updated_at":"2026-06-03T11:57:05-04:00","requisition_id":"111","title":"Director, GMP Quality Assurance","company_name":"Oruka Therapeutics","first_published":"2026-05-28T16:58:43-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Us:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit \u0026lt;a href=\u0026quot;http://www.orukatx.com\u0026quot;\u0026gt;www.orukatx.com\u0026lt;/a\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As we build our core team, we\u0026#39;re seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.\u0026amp;nbsp; Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. \u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Job Title:\u0026lt;/strong\u0026gt; Director, GMP Quality Assurance\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Location: \u0026lt;/strong\u0026gt;Hybrid – Waltham, MA or Menlo Park, CA.\u0026amp;nbsp; Candidates will be required to be in-office\u0026amp;nbsp;3 days/week.\u0026amp;nbsp; Open to remote for non-local candidates.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Role Overview:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Director of GMP Quality Assurance, reporting to the Senior Director of GMP Quality,\u0026amp;nbsp; \u0026amp;nbsp;will be responsible for providing quality oversight for Oruka’s clinical development programs and manufacturing.\u0026amp;nbsp; You will be responsible to ensure Oruka’s programs are advanced through the development pipeline in compliance with phase-appropriate regulatory requirements, applicable guidelines, and industry best practices.\u0026amp;nbsp; You have a strong background in GMP quality and manufacturing of biologics, with an emphasis on external manufacturing CDMO interaction and partnership.\u0026amp;nbsp; You should have an innate approach that is centered on integrity, collaboration, and organization and a proven track record of operational execution in a development environment.\u0026amp;nbsp; You are a hands on, natural self-starter with strong organizational skills who thrives in a busy, fast-paced environment and can communicate effectively with executive leaders and external partners and customers.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Key Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Provide GMP quality support and guidance for Oruka’s CMC programs, ensuring compliance with applicable GxP regulations and guidelines.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support the negotiation, implementation, and maintenance of quality agreements with GMP suppliers.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Review and approve GMP documentation, including master batch records, executed batch records, analytical methods, specifications, validation protocols and reports, tech transfer documentation, stability protocols and reports, and risk-assessment documentation.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Review and support GMP investigations related to deviations, ensuring appropriate root cause analysis and CAPA development and implementation.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Review change controls, CAPAs, and OOS/OOT investigations in collaboration with internal and external stakeholders.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Perform or support lot disposition activities.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure GMP quality documentation is appropriately archived and readily retrievable.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Investigate and assess quality events such as product complaints and temperature excursions, and manage associated follow-up actions.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Contribute to the development and maintenance of Oruka’s Quality Management System (QMS), including authoring and reviewing SOPs and quality procedures as needed.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Review and approve clinical product labeling, ensure proper controls in place across label management lifecycle.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Assist with the development, tracking, and reporting of GMP quality metrics and KPIs; identify trends and support continuous improvement initiatives.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support inspection readiness activities for both Oruka and its GMP suppliers.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide GMP quality review and input for regulatory submissions and agency responses.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Escalate quality risks and compliance issues appropriately and support risk-based decision making.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Promote a culture of quality and continuous improvement across the organization.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Approximately \u0026lt;strong\u0026gt;15–20% travel\u0026lt;/strong\u0026gt; (domestic and international) to GMP suppliers and Oruka offices.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026lt;em\u0026gt;Required\u0026lt;/em\u0026gt;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Bachelor’s degree in a scientific field with a minimum of 10 years of experience in GMP Quality or Manufacturing in a biotechnology or pharmaceutical setting; experience in biologics is required.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;In depth knowledge of cGMP, FDA/EMA regulations, and applicable guidelines (e.g., ICH, WHO)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience supporting early phase clinical through commercial manufacturing, including the use of contract manufacturers\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong analytical, investigative, and problem-solving skills, with the ability to design creative solutions to complex challenges.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent interpersonal and communication skills, with a strong team orientation and an ability to mentor and develop junior staff.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to work in a fast-paced, ever-changing environment, prioritizing and managing multiple tasks simultaneously.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;Able to travel domestically and internationally.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026lt;em\u0026gt;Preferred\u0026lt;/em\u0026gt;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Experience supporting the onboarding and oversight of new GMP vendors or CDMOs.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Prior experience contributing to the build-out or enhancement of a QMS in a development-stage company.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with visual management dashboards (Excel/Smartsheet).\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Prior involvement in supporting regulatory inspections and authoring/reviewing regulatory submissions.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Compensation:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;The anticipated salary range is $213,000-$240,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;Job Location:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Hybrid – Waltham, MA or Menlo Park, CA.\u0026amp;nbsp; Candidates will be required to be in-office\u0026amp;nbsp;3 days/week.\u0026amp;nbsp; Open to remote for non-local candidates.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;We\u0026#39;re looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Salary Range for the Role\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$213,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$240,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What We Offer:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Competitive salary and benefits package.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Opportunities for professional growth and development.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4017356008,"name":"Quality","child_ids":[],"parent_id":null}],"offices":[{"id":4008136008,"name":"Oruka Tx-Menlo Park","location":"Menlo Park, California, United States","child_ids":[],"parent_id":null},{"id":4008137008,"name":"Oruka Tx-Waltham, MA","location":"Waltham, Massachusetts, United States","child_ids":[],"parent_id":null},{"id":4014100008,"name":"Remote","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/oruka/jobs/5210738008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_required","internal_job_id":4470018008,"location":{"name":"Remote"},"metadata":null,"id":5210738008,"updated_at":"2026-05-20T14:38:42-04:00","requisition_id":"96","title":"Director of Biostatistics","company_name":"Oruka Therapeutics","first_published":"2026-05-20T14:38:42-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Us:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit \u0026lt;a href=\u0026quot;http://www.orukatx.com\u0026quot;\u0026gt;www.orukatx.com\u0026lt;/a\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As we build our core team, we\u0026#39;re seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.\u0026amp;nbsp; Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. \u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Job Title: \u0026lt;/strong\u0026gt;Director of Biostatistics \u0026amp;nbsp; \u0026amp;nbsp;\u0026lt;strong\u0026gt; \u0026amp;nbsp; \u0026amp;nbsp;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Location: \u0026lt;/strong\u0026gt;Remote OR Hybrid 3 days/week if located near office in either Waltham, MA or Menlo Park, CA will be required.\u0026amp;nbsp; \u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Role Overview: \u0026lt;/strong\u0026gt;The Director of Biostatistics will provide statistical leadership and strategic direction for our clinical development programs. This individual will serve as the lead biostatistician and will be responsible for providing expert guidance on study design, statistical analysis plans, and the interpretation of clinical trial results as well as statistical support for regulatory submission activities. The candidate will represent the Biostatistics function at internal and external meetings. The ideal candidate will bring a strong foundation in statistical methodology, curiosity for staying informed on advances in statistics, proficiency in statistical programming languages, and the ability to work collaboratively across different functions in a fast-paced biotech environment.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Key Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Lead statistical strategy for Oruka’s clinical development programs, including study design, protocol input, and statistical analysis planning.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Plan and track biostatistics timeline and resources for assigned projects, ensuring timeline completion of quality deliverables. Proactively communicate resource needs.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide statistical input for data management and programming deliverables (e.g. data collection tools, analysis datasets) to ensure that they support the protocol specified goals and statistical analyses.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Develop statistical programs, as needed, in support of ad-hoc requests, manuscripts and presentations and provide statistical review of scientific reports and publications, ensuring appropriate and accurate data presentation.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Write the statistical sections of regulatory documents and collaborate with Clinical and Regulatory to support Oruka’s regulatory strategy.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Participate in the assessment, selection, and oversight of CROs within area of responsibility.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure compliance with company SOPs and working practices, industry and regulatory standards.\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Ph.D. in Biostatistics, Statistics, or a related field with 7+ years of experience in clinical trials, or a Masters degree with 10+ years of experience\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Up-to-date expertise/knowledge of statistical methodologies related to areas such as clinical trial design, statistical modeling and analysis\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Capability to provide statistical leadership to cross-functional teams at the study and project level, exercise independent judgement and provide oversight to junior statisticians\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Familiarity in the design, data capture, and analysis of clinical trials with potentially high placebo response\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience in the area of Immunology and Inflammation a plus.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Knowledge of applicable FDA regulations and ICH guidelines\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Expertise in CDISC standards, including ADaM requirements\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Advanced knowledge of the SAS programming language; knowledge of R or similar language a plus.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong organizational and time management skills, and the ability to prioritize multiple deliverables and ad-hoc requests.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent communication, leadership, and analytical skills.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated ability to work effectively in a dynamic, cross-functional, and fast-paced team environment.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Compensation:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;The anticipated salary range for candidates\u0026amp;nbsp;is $213,000 to $240,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;We\u0026#39;re looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Salary Range for the Role\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$213,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$240,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What We Offer:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Competitive salary and benefits package.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Opportunities for professional growth and development.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4031817008,"name":"Biometrics","child_ids":[],"parent_id":null}],"offices":[{"id":4014100008,"name":"Remote","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/oruka/jobs/5234803008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_optional","internal_job_id":4481694008,"location":{"name":"Menlo Park, California, United States; Remote; Waltham, Massachusetts, United States"},"metadata":null,"id":5234803008,"updated_at":"2026-05-28T16:47:14-04:00","requisition_id":"108","title":"Director, Quality Control","company_name":"Oruka Therapeutics","first_published":"2026-05-28T16:47:14-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Us:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit \u0026lt;a href=\u0026quot;http://www.orukatx.com\u0026quot;\u0026gt;www.orukatx.com\u0026lt;/a\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As we build our core team, we\u0026#39;re seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.\u0026amp;nbsp; Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. \u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Job Title: \u0026lt;/strong\u0026gt;Director, Quality Control\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Location: \u0026lt;/strong\u0026gt;Hybrid – Waltham, MA or Menlo Park, CA.\u0026amp;nbsp; Candidates will be required to be in-office\u0026amp;nbsp;3 days/week\u0026amp;nbsp;\u0026amp;nbsp; Open to remote for non-local candidates.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Role Overview:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Director, Quality Control – Combination Products will provide strategic and operational leadership for the Quality Control function supporting late-stage clinical development, analytical testing oversight for clinical drug substance and drug product, process performance qualification (PPQ), regulatory submissions, and commercial launch readiness for monoclonal antibody drug products and combination products, including pre-filled syringes and autoinjectors.\u0026amp;nbsp; This role will ensure timely, compliant, and scientifically sound oversight of release, stability, characterization, in-process, and method lifecycle activities performed at CMOs and contract testing laboratories.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This role is responsible for ensuring that all QC systems, analytical methods, and testing programs are inspection-ready and aligned with global regulatory expectations for commercial biologics. The Director will partner cross-functionally and externally to enable successful PPQ execution, analytical method validation, regulatory approval, and commercial launch readiness.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Key Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;QC Strategy, Clinical Execution \u0026amp;amp; Commercial Readiness\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Develop and execute the enterprise QC strategy to support clinical product testing, Phase 3 clinical trials, PPQ, BLA submission, and commercial launch.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Build scalable QC systems, processes, governance, and organizational capabilities aligned with commercial-stage operations.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Establish and maintain analytical control strategies for drug substance (DS), drug product (DP), and combination products.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure inspection readiness across QC operations, documentation, data integrity, and external partner networks.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Serve as a strategic advisor to Quality and CMC on analytical and QC-related risks, compliance considerations, and commercialization readiness.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Analytical Methods, Validation \u0026amp;amp; Lifecycle Management\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Lead and provide oversight of analytical method qualification, validation, transfer, verification, and lifecycle management in alignment with ICH, FDA, EMA, and global regulatory expectations.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure all release, characterization, and stability-indicating methods are validated and commercially sustainable prior to BLA submission.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Oversee analytical comparability strategies, method bridging activities, and technology transfers across CMOs and contract laboratories.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Drive continuous improvement of analytical control strategies and testing programs through data trending and lifecycle management principles.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure effective governance of reference standards, critical reagents, and assay performance monitoring programs.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;PPQ, Validation \u0026amp;amp; Continued Process Verification\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Partner cross-functionally with Manufacturing, MSAT, and CMC teams to ensure QC readiness for PPQ execution and commercial manufacturing.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide QC oversight for in-process, release, and stability testing supporting validation campaigns and commercial supply.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support continued process verification (CPV) programs through statistical trending, data analysis, and ongoing monitoring of product quality attributes.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure timely and compliant batch disposition support through robust data review and issue escalation processes.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Combination Product Quality Control Leadership\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Lead QC strategy and oversight for combination products, including pre-filled syringes, autoinjectors, and device constituent components.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure compliant testing strategies for container closure integrity, product-device compatibility, particulate matter, functionality, and device-related attributes.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Oversee QC support for extractables and leachables (E\u0026amp;amp;L), shipping validation, and stability programs associated with delivery systems.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure QC operations and external partners comply with applicable combination product regulations, including 21 CFR Part 4 and relevant global guidance.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support commercial readiness and lifecycle management for combination product manufacturing and release.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Clinical Product Analytical Testing Oversight and External Laboratory Management\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Provide QC oversight for analytical testing of clinical drug substance and drug product, including release, stability, in-process, characterization, and comparability testing.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide oversight of contract testing laboratories and CMOs, including selection, qualification, governance, performance management, and risk mitigation.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Establish and maintain Quality Agreements and analytical governance structures aligned with commercial and regulatory expectations.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lead oversight activities during critical manufacturing campaigns, investigations, audits, and inspection preparation activities.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Drive accountability and performance across the external analytical network to ensure reliable execution and compliance.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Investigations, Compliance \u0026amp;amp; Quality Systems\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lead complex investigations involving OOS, OOT, deviations, laboratory events, complaints, and analytical discrepancies.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure robust root cause analysis, effective CAPA implementation, and sustainable compliance solutions.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Champion data integrity principles (ALCOA+) and ensure compliance across QC systems, laboratories, and third-party partners.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Establish meaningful QC metrics, dashboards, and management review processes to drive operational excellence and continuous improvement.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Regulatory \u0026amp;amp; Inspection Support\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Author, review, and approve QC-related sections of regulatory submissions, including analytical methods, specifications, validation reports, comparability assessments, and stability data.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Serve as the QC Subject Matter Expert during regulatory inspections, pre-approval inspections (PAIs), and partner audits.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lead responses to health authority questions, observations, and deficiency letters related to analytical and QC activities.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Maintain current knowledge of evolving global regulatory expectations for biologics and combination products.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Required\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Bachelor’s degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or related scientific discipline; advanced degree preferred.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;10+ years of progressive Quality Control and analytical experience within GMP biopharmaceutical environments, including late-stage clinical and commercial readiness activities.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience overseeing GMP analytical testing for clinical-stage biologic DS and DP, including release, stability, in-process, and/or comparability testing performed by CMOs or contract testing laboratories.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated experience supporting BLA and/or MAA submissions, regulatory inspections, and commercial launch preparation.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Deep expertise in biologics analytical methods, including chromatographic, electrophoretic, cell-based, compendial, and microbiological techniques.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Extensive experience with analytical method validation, lifecycle management, comparability, and technology transfer.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong knowledge of cGMP regulations and global regulatory expectations, including 21 CFR Parts 210, 211, and 4.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Hands-on experience supporting combination products such as pre-filled syringes, autoinjectors, or related delivery systems.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proven success leading QC support for PPQ campaigns, validation activities, and commercial manufacturing readiness.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated experience managing CMOs, contract laboratories, and global external testing networks.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong understanding of data integrity principles, electronic systems, and QC compliance requirements.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proven ability to build and scale Quality organizations in a fast-paced biotech environment.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent leadership, communication, and cross-functional collaboration skills with the ability to influence at all organizational levels.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Preferred\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Direct experience supporting successful BLA approval and commercial product launch.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience in a rapidly growing biotechnology company transitioning to commercial operations.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Knowledge of extractables/leachables, container closure systems, and device constituent testing.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience implementing or optimizing LIMS, stability systems, and digital QC infrastructure.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience supporting global regulatory filings and international commercialization activities.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Compensation:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;The anticipated salary range is $213,000 - $240,000.\u0026amp;nbsp;The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc.\u0026amp;nbsp;Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;Location: \u0026lt;/strong\u0026gt;Hybrid – Waltham, MA or Menlo Park, CA.\u0026amp;nbsp; Candidates will be required to be in-office 3 days/week\u0026amp;nbsp;\u0026amp;nbsp; Open to remote for non-local candidates\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;We\u0026#39;re looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Salary Range for the Role\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$213,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$240,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What We Offer:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Competitive salary and benefits package.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Opportunities for professional growth and development.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4017356008,"name":"Quality","child_ids":[],"parent_id":null}],"offices":[{"id":4008136008,"name":"Oruka Tx-Menlo Park","location":"Menlo Park, California, United States","child_ids":[],"parent_id":null},{"id":4008137008,"name":"Oruka Tx-Waltham, MA","location":"Waltham, Massachusetts, United States","child_ids":[],"parent_id":null},{"id":4014100008,"name":"Remote","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/oruka/jobs/5184371008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_required","internal_job_id":4457697008,"location":{"name":"Waltham, Massachusetts, United States"},"metadata":null,"id":5184371008,"updated_at":"2026-04-10T12:49:23-04:00","requisition_id":"83","title":"Director / Senior Director, Regulatory CMC (Biologics)","company_name":"Oruka Therapeutics","first_published":"2026-04-10T12:49:23-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Us:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit \u0026lt;a href=\u0026quot;http://www.orukatx.com\u0026quot;\u0026gt;www.orukatx.com\u0026lt;/a\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As we build our core team, we\u0026#39;re seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.\u0026amp;nbsp; Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. \u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Job Title: \u0026lt;/strong\u0026gt;Director / Senior Director, Regulatory CMC (Biologics)\u0026lt;strong\u0026gt; \u0026amp;nbsp; \u0026amp;nbsp; \u0026amp;nbsp;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Location: \u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;Hybrid – Waltham, MA\u0026lt;/strong\u0026gt; Candidates will be required to be in-office\u0026lt;em\u0026gt;\u0026amp;nbsp;\u0026lt;/em\u0026gt;3 days/week.\u0026lt;strong\u0026gt;\u0026amp;nbsp; \u0026amp;nbsp; \u0026amp;nbsp; \u0026amp;nbsp; \u0026amp;nbsp;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Role Overview:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;We are seeking an experienced and motivated regulatory CMC leader to shape strategy and execution across early-to-late-stage biologics programs. In this role, you will own the development of high-quality regulatory CMC submissions and guide cross-functional teams on phase-appropriate global regulatory expectations. You are an ideal candidate if you bring deep expertise in biologics development and manufacturing, including strong experience with drug substance and drug product CMC submissions. You will have the opportunity to influence program strategy, foster collaboration across CMC, QA, RA, Supply Chain, and external partners, and drive key decisions that support multiple programs in our rapidly growing biologics pipeline. This is a highly visible role where you will be responsible for submissions that are aligned with FDA, EMA, ICH, and WHO guidelines while supporting corporate and program level objectives.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Key Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Own and drive global regulatory CMC strategy for drug substance and drug product across all stages (IND through BLA)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lead development of high-quality CMC dossiers, timelines, and submission strategies for global filings\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Serve as the CMC regulatory SME on program teams, influencing cross-functional decisions and overall development strategy\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaborate with CMC, Supply chain, QA and RA functions to support maintenance of product compliance, shelf life, and change control procedures\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lead cross-functional coordination to plan and deliver timely, high-quality responses to CMC regulatory information requests\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure all submissions meet phase-appropriate expectations and align with FDA, HC, EMA, ICH, and WHO guidelines\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Anticipate regulatory risks and proactively develop mitigation strategies to keep programs on track\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaborate effectively with internal teams and external partners including CDMOs to generate high quality source documents\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Guide late-stage development planning, including process characterization, PPQ, and readiness for commercial filings\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Bring a clear, proactive, solution-oriented mindset with the attitude to manage competing priorities\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Thrive in a fast-paced biotech environment where agility and accountability matter\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Contribute to a culture of collaboration, transparency, and continuous improvement\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;MS or PhD in life sciences with 10+ years of experience in a biologics focused CMC role and a minimum of 5+ years of direct regulatory CMC experience\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong command of cGMPs, biologics development (manufacturing, release, stability) and associated global regulatory expectations. Experience with drug device combinations (e.g., prefilled syringes, auto injectors) is preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proven track record of leading global CMC submissions and preparing briefings for milestone interactions with global health authorities (FDA, EMA etc.)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Broad experience across development stages from early development through late stage and commercialization; Hands-on experience with BLA CMC submission is ideal\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Working knowledge of drug substance and drug product CMC development, including process, analytical development, QC, and shelf-life strategy\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated ability to operate strategically while staying close to overall regulatory planning and execution\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience building alignment across teams (CMC, QA, Supply chain, QA, RA and PM) in a fast-paced biotech environment\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong scientific and communication skills with operational experience in tracking multiple activities, deliverables, and timelines\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Compensation:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;The anticipated salary range for candidates, who will work in Waltham, MA, is $213,000-240,000 for Director and $255,00-286,000 for Senior Director. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;We\u0026#39;re looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Salary Range for the Role\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$213,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$286,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What We Offer:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Competitive salary and benefits package.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Opportunities for professional growth and development.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4017352008,"name":"CMC","child_ids":[],"parent_id":null}],"offices":[{"id":4008137008,"name":"Oruka Tx-Waltham, MA","location":"Waltham, Massachusetts, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/oruka/jobs/5206495008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_required","internal_job_id":4467927008,"location":{"name":"Menlo Park, California, United States; Remote; Waltham, Massachusetts, United States"},"metadata":null,"id":5206495008,"updated_at":"2026-04-30T12:40:57-04:00","requisition_id":"95","title":"Executive Medical Director, Clinical Development ","company_name":"Oruka Therapeutics","first_published":"2026-04-30T12:36:16-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Us:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit \u0026lt;a href=\u0026quot;http://www.orukatx.com\u0026quot;\u0026gt;www.orukatx.com\u0026lt;/a\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As we build our core team, we\u0026#39;re seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.\u0026amp;nbsp; Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. \u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Job Title: \u0026lt;/strong\u0026gt;Executive Medical Director, Clinical Development\u0026lt;strong\u0026gt; \u0026amp;nbsp; \u0026amp;nbsp; \u0026amp;nbsp; \u0026amp;nbsp;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Location: \u0026lt;/strong\u0026gt;Remote OR Hybrid 3 days/week if located near office in either Waltham, MA or Menlo Park, CA will be required.\u0026amp;nbsp; \u0026lt;strong\u0026gt;\u0026amp;nbsp; \u0026amp;nbsp; \u0026amp;nbsp; \u0026amp;nbsp; \u0026lt;/strong\u0026gt;.\u0026lt;strong\u0026gt;\u0026amp;nbsp; \u0026amp;nbsp; \u0026amp;nbsp; \u0026amp;nbsp; \u0026amp;nbsp;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Role Overview: \u0026lt;/strong\u0026gt;The Executive Medical Director of Clinical Development plays a key role in leading the design, execution, and oversight of clinical trials at an asset level, ensuring high-quality data generation to support the safety and efficacy of our pipeline products.\u0026amp;nbsp; This role involves leading and developing a team and contributing to and influencing clinical development strategy across an asset, including study design, implementation, and data interpretation, while working cross-functionally to align clinical activities with overall development plans.\u0026amp;nbsp; The Executive Medical Director collaborates closely with internal and external stakeholders to ensure trial execution meets regulatory, scientific, and business objectives in a fast-paced environment.\u0026amp;nbsp; The role reports to the Vice President of Clinical Development.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Key Responsibilities: \u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;Strategic Leadership:\u0026lt;/strong\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Drives the clinical development strategy for one or more assets\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Identifies critical clinical development milestones and ensures team alignment and accountability toward meeting timelines\u0026lt;/li\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Provides leadership to the clinical team’s contribution to clinical study reports, key clinical documents, and regulatory submissions\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Directly manages and/or mentors Medical Directors, Clinical Scientists and other team members as appropriate\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;Clinical Trial Design and Oversight:\u0026lt;/strong\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Leads and contributes to the development of clinical trial protocols, including patient selection criteria, study endpoints, and data collection methods\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Oversees the conduct of clinical trials, ensuring adherence to protocols and good clinical practice (GCP) guidelines, working closely with CROs and external partners to ensure efficient execution\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Reviews and interprets clinical data to assess the safety and efficacy of the investigational drug, driving timely, data-driven decisions\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Manages the clinical contribution to documents required during development (including but not limited to: Clinical Study Protocols, Investigator Brochures, Clinical Study Reports)\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;Medical Expertise:\u0026lt;/strong\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Provides deep medical and scientific expertise in the therapeutic area, disease state, and potential drug effects\u0026amp;nbsp;\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Reviews clinical data to identify and analyze safety concerns and adverse events, working with the pharmacovigilance team on continual benefit-risk assessment\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Stays current with relevant medical literature and clinical trial methodologies\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Contributes medical expertise to external interactions, including \u0026lt;strong\u0026gt;KOL engagement, advisory boards, and regulatory interactions as appropriate\u0026lt;/strong\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;Cross-Functional Collaboration:\u0026lt;/strong\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Works closely with other functions including clinical operations, regulatory affairs, medical affairs, biometrics, pharmacovigilance, pre-clinical and project management teams to ensure alignment between clinical strategy and execution in a fast-paced environment\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Presents clinical data to internal and external stakeholders as appropriate\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;People Leadership \u0026amp;amp; Team Development:\u0026lt;/strong\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Leads and develops a high-impact team\u0026lt;strong\u0026gt; \u0026lt;/strong\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provides coaching, mentorship, and performance management\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Fosters a culture of accountability, collaboration, and scientific rigor\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Supports hiring and resource planning in partnership with leadership\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Medical degree (MD) ideally with board certification in a relevant specialty\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Extensive experience in clinical research and development, including within the pharmaceutical industry with progression of career demonstrating clinical leadership\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proven people leadership experience, including managing and developing direct reports in small or growing teams\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong understanding of clinical trial design, GCP guidelines, and regulatory requirements, ideally with Phase 2 and 3 clinical study experience\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent communication, leadership, and analytical skills\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated ability to contribute to and influence clinical strategy while driving hands-on execution\u0026amp;nbsp;\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Experience working in a small or emerging biotech environment, with comfort operating in a fast-paced setting\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Compensation:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;The anticipated salary range for candidates is $331,000 to $368,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;We\u0026#39;re looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Salary Range for the Role\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$331,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$368,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What We Offer:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Competitive salary and benefits package.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Opportunities for professional growth and development.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4015815008,"name":"Clinical Development","child_ids":[],"parent_id":null}],"offices":[{"id":4008136008,"name":"Oruka Tx-Menlo Park","location":"Menlo Park, California, United States","child_ids":[],"parent_id":null},{"id":4008137008,"name":"Oruka Tx-Waltham, MA","location":"Waltham, Massachusetts, United States","child_ids":[],"parent_id":null},{"id":4014100008,"name":"Remote","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/oruka/jobs/5234862008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_optional","internal_job_id":4481784008,"location":{"name":"Waltham, Massachusetts, United States"},"metadata":null,"id":5234862008,"updated_at":"2026-05-28T17:15:44-04:00","requisition_id":"112","title":"Manager/Sr. Manager QA Supply Chain","company_name":"Oruka Therapeutics","first_published":"2026-05-28T17:15:44-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Us:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit \u0026lt;a href=\u0026quot;http://www.orukatx.com\u0026quot;\u0026gt;www.orukatx.com\u0026lt;/a\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As we build our core team, we\u0026#39;re seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.\u0026amp;nbsp; Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. \u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Job Title: \u0026lt;/strong\u0026gt;Manager / Senior Manager, QA Supply Chain\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Location: \u0026lt;/strong\u0026gt;Hybrid – Waltham, MA\u0026lt;em\u0026gt;.\u0026lt;/em\u0026gt;\u0026amp;nbsp;Candidates will be required to be in-office\u0026amp;nbsp;3 days/week.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Role Overview:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Manager / Senior Manager, QA Supply Chain is responsible for providing quality oversight of clinical supply chain activities supporting Phase 2 and Phase 3 programs, including packaging, labeling, distribution, and cold chain management. This role ensures inspection readiness and compliance across all clinical supply operations.\u0026amp;nbsp; This role ensures that all supply chain operations are conducted in compliance with cGMP, GCP, and GDP requirements, with a focus on IRT-driven clinical supply management, temperature control, and investigational product traceability. The individual will partner cross-functionally with Clinical Operations, CMC, Regulatory, and external vendors to ensure uninterrupted clinical supply and inspection readiness.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Key Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;Clinical Supply Chain Quality Oversight\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Provide QA oversight of clinical supply chain activities, including packaging, labeling, storage, and distribution of investigational products.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure compliance with GMP, GDP, and GCP requirements across internal teams and external vendors.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support phase-appropriate quality systems and procedures as programs advance from Phase 2 to Phase 3.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;IRT (Interactive Response Technology) \u0026amp;amp; Clinical Supply Management\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Provide QA support and oversight for IRT systems, including review and approval of system specifications, user acceptance testing (UAT), and change controls.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure appropriate controls are in place for randomization, kit assignment, and drug accountability.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Partner with Clinical Operations and Supply Chain to ensure accurate and compliant IRT configuration and use.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaborate with cross-functional clinical teams to review and update study specific pharmacy manuals.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;Labeling \u0026amp;amp; Packaging Operations\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Review and approve clinical labeling content, including country-specific requirements and regulatory compliance.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide QA oversight of packaging and labeling operations at CMOs and depots.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure label reconciliation, issuance, and destruction processes are compliant and traceable.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;Temperature Excursions \u0026amp;amp; Cold Chain Management\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Oversee management of temperature excursions, including impact assessments, investigations, and disposition decisions.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure appropriate controls for cold chain logistics, including shipping qualification, lane validation, and temperature monitoring.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Review excursion data and ensure alignment with stability data and product quality requirements.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;Distribution \u0026amp;amp; Logistics Oversight\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Provide QA oversight of global distribution activities, including depot operations and comparator sourcing.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure chain of custody and chain of identity are maintained for all investigational products.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support qualification and oversight of depots, logistics providers, and distribution partners.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;Deviations, Product Complaints \u0026amp;amp; CAPA\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Lead or support investigations related to deviations, temperature excursions, shipment issues, product complaints, and labeling errors.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure timely and thorough root cause analysis and CAPA implementation.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Track and trend supply chain quality events to identify systemic improvements.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;Regulatory \u0026amp;amp; Inspection-Readiness\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Support QA Supply Chain activities for regulatory submissions and inspections.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure documentation and systems are inspection-ready for clinical and late-stage development programs.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support responses to health authority inquiries related to clinical supply chain operations.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026lt;em\u0026gt;Required\u0026lt;/em\u0026gt;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Bachelor’s degree in Life Sciences, Supply Chain, or related discipline.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;5+ years (Manager) or 8+ years (Senior Manager) of experience in Quality Assurance within GMP/GDP environments.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience supporting clinical supply chain operations in Phase 2 and/or Phase 3 trials.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Working knowledge of GMP, GDP, and GCP regulations applicable to investigational products.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with IRT systems and clinical supply management processes.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Hands-on experience with clinical labeling, packaging, and distribution oversight.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience managing temperature excursions and cold chain logistics.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Familiarity with deviation management, investigations, and CAPA systems.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong organizational and problem-solving skills with attention to detail.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to work cross-functionally and manage multiple priorities in a fast-paced environment.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Preferred\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Experience supporting global clinical trials and multi-region supply chains.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with comparator sourcing and depot management.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Familiarity with electronic quality systems (eQMS) and IRT platforms.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience participating in regulatory inspections.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Background in biologics or combination products.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Compensation:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;The anticipated salary range for candidates who will work in Waltham, MA for Manager level is $146,000 - $161,000 and for Sr. Manager is $161,000 - $187,000.\u0026amp;nbsp;The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc.\u0026amp;nbsp;Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;Job Location:\u0026amp;nbsp; \u0026lt;/strong\u0026gt;Hybrid – Waltham, MA\u0026lt;em\u0026gt;.\u0026lt;/em\u0026gt;\u0026amp;nbsp;Candidates will be required to be in-office\u0026amp;nbsp;3 days/week\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;We\u0026#39;re looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Salary Range for the Role\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$146,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$187,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What We Offer:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Competitive salary and benefits package.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Opportunities for professional growth and development.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4017356008,"name":"Quality","child_ids":[],"parent_id":null}],"offices":[{"id":4008137008,"name":"Oruka Tx-Waltham, MA","location":"Waltham, Massachusetts, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/oruka/jobs/5212486008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_required","internal_job_id":4470876008,"location":{"name":"Remote"},"metadata":null,"id":5212486008,"updated_at":"2026-05-06T19:31:29-04:00","requisition_id":"101","title":"Medical Science Liaison-North Central","company_name":"Oruka Therapeutics","first_published":"2026-05-06T19:31:29-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Us:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit \u0026lt;a href=\u0026quot;http://www.orukatx.com\u0026quot;\u0026gt;www.orukatx.com\u0026lt;/a\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As we build our core team, we\u0026#39;re seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.\u0026amp;nbsp; Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. \u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Job Title:\u0026lt;/strong\u0026gt; Medical Science Liaison-\u0026lt;strong\u0026gt;North Central\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Location: \u0026lt;/strong\u0026gt;Field-based,\u0026lt;strong\u0026gt; \u0026lt;/strong\u0026gt;covering\u0026lt;strong\u0026gt;\u0026amp;nbsp;IL, IN, MI, WI, MO, OH, Western PA/Pittsburgh\u0026amp;nbsp;\u0026lt;/strong\u0026gt;. \u0026lt;strong\u0026gt;The candidate is required to live in the territory.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Role Overview:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Oruka is looking for a Medical Science Liaison’s (MSL), a field based scientific expert that strategically supports medical affairs objectives and serves as a conduit of communication between clinical community and Oruka’s internal team.\u0026amp;nbsp; The MSL is responsible for developing and managing peer-to-peer relationships with a variety of health care professionals and engaging in high quality communications about Oruka’s products and clinical trials in their territory. There is a special emphasis on working with clinical trial sites.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Summary:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;MSL will build and execute territory engagement plan that establishes relationships with key external stakeholders and supports Oruka’s medical strategy.\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Key Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Identify, develop, and maintain collaborative relationships with current and future national and regional key opinion leaders, speakers and investigators through meaningful scientific exchange\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Stay\u0026amp;nbsp;informed of medical and scientific developments in Dermatology and related fields by continuously reviewing relevant literature, monitoring competitor activities, networking with experts, and attending relevant conferences\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support national and regional scientific congresses with KOL engagements, poster /abstract coverage, booth staffing, and company debriefs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide internal stakeholders with feedback and actionable insights from interactions and discussions with HCPs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Identify, engage, and support investigators and site staff of high-impact, high-performing clinical research sites for Oruka’s clinical development programs\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Advanced degree in life sciences (PharmD, PhD, MD/DO, MSN, NP/DNP, DMS/PA or equivalent) is required\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Minimum of 5 years relevant clinical and/or industry experience required, experience in Dermatology strongly preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Prior experience as a field medical science liaison required, experience in Dermatology preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Routine and tangible experience in a field medical role working with CRO and clinical operations preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Relevant therapeutic area knowledge, comprehensive understanding of drug development process, clinical trial design, safety monitoring, and regulatory landscape in the pharmaceutical/biotechnology industry\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Self-driven and ability to work independently with minimal direct supervision\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Exceptional communication and time management skills\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Applicants must live within applicable territory with convenient access to national/international airport.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Travel Requirements:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Business travel, by air or car, is required for regular external business meetings with customers and intermittent internal company meetings (up to 75% of time)\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Compensation:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;The anticipated salary range for candidates who will work remotely is $182,00 to $235,00. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer, and this salary range may not reflect positions that work in other states.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;We\u0026#39;re looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Salary Range for the Role\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$182,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$235,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What We Offer:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Competitive salary and benefits package.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Opportunities for professional growth and development.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4017354008,"name":"Medical Affairs","child_ids":[],"parent_id":null}],"offices":[{"id":4014100008,"name":"Remote","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/oruka/jobs/5212107008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_required","internal_job_id":4470700008,"location":{"name":"Remote"},"metadata":null,"id":5212107008,"updated_at":"2026-05-06T19:28:28-04:00","requisition_id":"98","title":"Medical Science Liaison-Northeast","company_name":"Oruka Therapeutics","first_published":"2026-05-06T19:28:28-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Us:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit \u0026lt;a href=\u0026quot;http://www.orukatx.com\u0026quot;\u0026gt;www.orukatx.com\u0026lt;/a\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As we build our core team, we\u0026#39;re seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.\u0026amp;nbsp; Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. \u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Job Title:\u0026lt;/strong\u0026gt; Medical Science Liaison-\u0026lt;strong\u0026gt;Northeast\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Location: \u0026lt;/strong\u0026gt;Field-based,\u0026lt;strong\u0026gt; \u0026lt;/strong\u0026gt;covering\u0026lt;strong\u0026gt; MA, ME, NH, VT, CT, RI, NY, NJ, MD/DC, Eastern PA\u0026lt;/strong\u0026gt;. \u0026lt;strong\u0026gt;The candidate is required to live in the territory.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Role Overview:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Oruka is looking for a Medical Science Liaison’s (MSL), a field based scientific expert that strategically supports medical affairs objectives and serves as a conduit of communication between clinical community and Oruka’s internal team.\u0026amp;nbsp; The MSL is responsible for developing and managing peer-to-peer relationships with a variety of health care professionals and engaging in high quality communications about Oruka’s products and clinical trials in their territory. There is a special emphasis on working with clinical trial sites.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Summary:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;MSL will build and execute territory engagement plan that establishes relationships with key external stakeholders and supports Oruka’s medical strategy.\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Key Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Identify, develop, and maintain collaborative relationships with current and future national and regional key opinion leaders, speakers and investigators through meaningful scientific exchange\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Stay\u0026amp;nbsp;informed of medical and scientific developments in Dermatology and related fields by continuously reviewing relevant literature, monitoring competitor activities, networking with experts, and attending relevant conferences\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support national and regional scientific congresses with KOL engagements, poster /abstract coverage, booth staffing, and company debriefs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide internal stakeholders with feedback and actionable insights from interactions and discussions with HCPs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Identify, engage, and support investigators and site staff of high-impact, high-performing clinical research sites for Oruka’s clinical development programs\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Advanced degree in life sciences (PharmD, PhD, MD/DO, MSN, NP/DNP, DMS/PA or equivalent) is required\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Minimum of 5 years relevant clinical and/or industry experience required, experience in Dermatology strongly preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Prior experience as a field medical science liaison required, experience in Dermatology preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Routine and tangible experience in a field medical role working with CRO and clinical operations preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Relevant therapeutic area knowledge, comprehensive understanding of drug development process, clinical trial design, safety monitoring, and regulatory landscape in the pharmaceutical/biotechnology industry\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Self-driven and ability to work independently with minimal direct supervision\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Exceptional communication and time management skills\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Applicants must live within applicable territory with convenient access to national/international airport.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Travel Requirements:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Business travel, by air or car, is required for regular external business meetings with customers and intermittent internal company meetings (up to 75% of time)\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Compensation:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;The anticipated salary range for candidates who will work remotely is $182,00 to $235,00. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer, and this salary range may not reflect positions that work in other states.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;We\u0026#39;re looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Salary Range for the Role\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$182,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$235,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What We Offer:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Competitive salary and benefits package.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Opportunities for professional growth and development.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4017354008,"name":"Medical Affairs","child_ids":[],"parent_id":null}],"offices":[{"id":4014100008,"name":"Remote","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/oruka/jobs/5212489008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_required","internal_job_id":4470879008,"location":{"name":"Remote"},"metadata":null,"id":5212489008,"updated_at":"2026-05-06T19:32:30-04:00","requisition_id":"102","title":"Medical Science Liaison-Northwest","company_name":"Oruka Therapeutics","first_published":"2026-05-06T19:32:30-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Us:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit \u0026lt;a href=\u0026quot;http://www.orukatx.com\u0026quot;\u0026gt;www.orukatx.com\u0026lt;/a\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As we build our core team, we\u0026#39;re seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.\u0026amp;nbsp; Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. \u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Job Title:\u0026lt;/strong\u0026gt; Medical Science Liaison-\u0026lt;strong\u0026gt;Northwest\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Location: \u0026lt;/strong\u0026gt;Field-based,\u0026lt;strong\u0026gt; \u0026lt;/strong\u0026gt;covering \u0026lt;strong\u0026gt;CO, WY, UT, MT, ID, OR, WA, IA, ND, SD\u0026lt;/strong\u0026gt;. \u0026lt;strong\u0026gt;The candidate is required to live in the territory.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Role Overview:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Oruka is looking for a Medical Science Liaison’s (MSL), a field based scientific expert that strategically supports medical affairs objectives and serves as a conduit of communication between clinical community and Oruka’s internal team.\u0026amp;nbsp; The MSL is responsible for developing and managing peer-to-peer relationships with a variety of health care professionals and engaging in high quality communications about Oruka’s products and clinical trials in their territory. There is a special emphasis on working with clinical trial sites.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Summary:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;MSL will build and execute territory engagement plan that establishes relationships with key external stakeholders and supports Oruka’s medical strategy.\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Key Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Identify, develop, and maintain collaborative relationships with current and future national and regional key opinion leaders, speakers and investigators through meaningful scientific exchange\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Stay\u0026amp;nbsp;informed of medical and scientific developments in Dermatology and related fields by continuously reviewing relevant literature, monitoring competitor activities, networking with experts, and attending relevant conferences\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support national and regional scientific congresses with KOL engagements, poster /abstract coverage, booth staffing, and company debriefs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide internal stakeholders with feedback and actionable insights from interactions and discussions with HCPs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Identify, engage, and support investigators and site staff of high-impact, high-performing clinical research sites for Oruka’s clinical development programs\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Advanced degree in life sciences (PharmD, PhD, MD/DO, MSN, NP/DNP, DMS/PA or equivalent) is required\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Minimum of 5 years relevant clinical and/or industry experience required, experience in Dermatology strongly preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Prior experience as a field medical science liaison required, experience in Dermatology preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Routine and tangible experience in a field medical role working with CRO and clinical operations preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Relevant therapeutic area knowledge, comprehensive understanding of drug development process, clinical trial design, safety monitoring, and regulatory landscape in the pharmaceutical/biotechnology industry\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Self-driven and ability to work independently with minimal direct supervision\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Exceptional communication and time management skills\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Applicants must live within applicable territory with convenient access to national/international airport.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Travel Requirements:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Business travel, by air or car, is required for regular external business meetings with customers and intermittent internal company meetings (up to 75% of time)\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Compensation:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;The anticipated salary range for candidates who will work remotely is $182,00 to $235,00. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer, and this salary range may not reflect positions that work in other states.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;We\u0026#39;re looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Salary Range for the Role\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$182,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$235,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What We Offer:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Competitive salary and benefits package.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Opportunities for professional growth and development.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4017354008,"name":"Medical Affairs","child_ids":[],"parent_id":null}],"offices":[{"id":4014100008,"name":"Remote","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/oruka/jobs/5212478008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_required","internal_job_id":4470870008,"location":{"name":"Remote"},"metadata":null,"id":5212478008,"updated_at":"2026-05-06T19:35:39-04:00","requisition_id":"100","title":"Medical Science Liaison-South Central","company_name":"Oruka Therapeutics","first_published":"2026-05-06T19:33:12-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Us:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit \u0026lt;a href=\u0026quot;http://www.orukatx.com\u0026quot;\u0026gt;www.orukatx.com\u0026lt;/a\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As we build our core team, we\u0026#39;re seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.\u0026amp;nbsp; Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. \u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Job Title:\u0026lt;/strong\u0026gt; Medical Science Liaison-\u0026lt;strong\u0026gt;South Central\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Location: \u0026lt;/strong\u0026gt;Field-based,\u0026lt;strong\u0026gt; \u0026lt;/strong\u0026gt;covering\u0026lt;strong\u0026gt; MS, LA, AR, OK, TX, AL, KS\u0026lt;/strong\u0026gt;. \u0026lt;strong\u0026gt;The candidate is required to live in the territory.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Role Overview:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Oruka is looking for a Medical Science Liaison’s (MSL), a field based scientific expert that strategically supports medical affairs objectives and serves as a conduit of communication between clinical community and Oruka’s internal team.\u0026amp;nbsp; The MSL is responsible for developing and managing peer-to-peer relationships with a variety of health care professionals and engaging in high quality communications about Oruka’s products and clinical trials in their territory. There is a special emphasis on working with clinical trial sites.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Summary:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;MSL will build and execute territory engagement plan that establishes relationships with key external stakeholders and supports Oruka’s medical strategy.\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Key Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Identify, develop, and maintain collaborative relationships with current and future national and regional key opinion leaders, speakers and investigators through meaningful scientific exchange\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Stay\u0026amp;nbsp;informed of medical and scientific developments in Dermatology and related fields by continuously reviewing relevant literature, monitoring competitor activities, networking with experts, and attending relevant conferences\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support national and regional scientific congresses with KOL engagements, poster /abstract coverage, booth staffing, and company debriefs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide internal stakeholders with feedback and actionable insights from interactions and discussions with HCPs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Identify, engage, and support investigators and site staff of high-impact, high-performing clinical research sites for Oruka’s clinical development programs\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Advanced degree in life sciences (PharmD, PhD, MD/DO, MSN, NP/DNP, DMS/PA or equivalent) is required\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Minimum of 5 years relevant clinical and/or industry experience required, experience in Dermatology strongly preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Prior experience as a field medical science liaison required, experience in Dermatology preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Routine and tangible experience in a field medical role working with CRO and clinical operations preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Relevant therapeutic area knowledge, comprehensive understanding of drug development process, clinical trial design, safety monitoring, and regulatory landscape in the pharmaceutical/biotechnology industry\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Self-driven and ability to work independently with minimal direct supervision\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Exceptional communication and time management skills\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Applicants must live within applicable territory with convenient access to national/international airport.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Travel Requirements:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Business travel, by air or car, is required for regular external business meetings with customers and intermittent internal company meetings (up to 75% of time)\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Compensation:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;The anticipated salary range for candidates who will work remotely is $182,00 to $235,00. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer, and this salary range may not reflect positions that work in other states.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;We\u0026#39;re looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Salary Range for the Role\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$182,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$235,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What We Offer:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Competitive salary and benefits package.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Opportunities for professional growth and development.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4017354008,"name":"Medical Affairs","child_ids":[],"parent_id":null}],"offices":[{"id":4014100008,"name":"Remote","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/oruka/jobs/5212447008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_required","internal_job_id":4470854008,"location":{"name":"Remote"},"metadata":null,"id":5212447008,"updated_at":"2026-05-06T19:36:47-04:00","requisition_id":"99","title":"Medical Science Liaison-Southeast","company_name":"Oruka Therapeutics","first_published":"2026-05-06T19:33:32-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Us:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit \u0026lt;a href=\u0026quot;http://www.orukatx.com\u0026quot;\u0026gt;www.orukatx.com\u0026lt;/a\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As we build our core team, we\u0026#39;re seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.\u0026amp;nbsp; Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. \u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Job Title:\u0026lt;/strong\u0026gt; Medical Science Liaison-\u0026lt;strong\u0026gt;Southeast\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Location: \u0026lt;/strong\u0026gt;Field-based,\u0026lt;strong\u0026gt; \u0026lt;/strong\u0026gt;covering\u0026lt;strong\u0026gt; \u0026lt;/strong\u0026gt;VA, WV, NC, SC, GA, FL, TN. \u0026lt;strong\u0026gt;The candidate is required to live in the territory.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Role Overview:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Oruka is looking for a Medical Science Liaison’s (MSL), a field based scientific expert that strategically supports medical affairs objectives and serves as a conduit of communication between clinical community and Oruka’s internal team.\u0026amp;nbsp; The MSL is responsible for developing and managing peer-to-peer relationships with a variety of health care professionals and engaging in high quality communications about Oruka’s products and clinical trials in their territory. There is a special emphasis on working with clinical trial sites.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Summary:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;MSL will build and execute territory engagement plan that establishes relationships with key external stakeholders and supports Oruka’s medical strategy.\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Key Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Identify, develop, and maintain collaborative relationships with current and future national and regional key opinion leaders, speakers and investigators through meaningful scientific exchange\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Stay\u0026amp;nbsp;informed of medical and scientific developments in Dermatology and related fields by continuously reviewing relevant literature, monitoring competitor activities, networking with experts, and attending relevant conferences\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support national and regional scientific congresses with KOL engagements, poster /abstract coverage, booth staffing, and company debriefs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide internal stakeholders with feedback and actionable insights from interactions and discussions with HCPs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Identify, engage, and support investigators and site staff of high-impact, high-performing clinical research sites for Oruka’s clinical development programs\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Advanced degree in life sciences (PharmD, PhD, MD/DO, MSN, NP/DNP, DMS/PA or equivalent) is required\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Minimum of 5 years relevant clinical and/or industry experience required, experience in Dermatology strongly preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Prior experience as a field medical science liaison required, experience in Dermatology preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Routine and tangible experience in a field medical role working with CRO and clinical operations preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Relevant therapeutic area knowledge, comprehensive understanding of drug development process, clinical trial design, safety monitoring, and regulatory landscape in the pharmaceutical/biotechnology industry\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Self-driven and ability to work independently with minimal direct supervision\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Exceptional communication and time management skills\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Applicants must live within applicable territory with convenient access to national/international airport.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Travel Requirements:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Business travel, by air or car, is required for regular external business meetings with customers and intermittent internal company meetings (up to 75% of time)\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Compensation:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;The anticipated salary range for candidates who will work remotely is $182,00 to $235,00. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer, and this salary range may not reflect positions that work in other states.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;We\u0026#39;re looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Salary Range for the Role\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$182,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$235,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What We Offer:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Competitive salary and benefits package.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Opportunities for professional growth and development.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4017354008,"name":"Medical Affairs","child_ids":[],"parent_id":null}],"offices":[{"id":4014100008,"name":"Remote","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/oruka/jobs/5232207008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_required","internal_job_id":4480548008,"location":{"name":"Waltham, Massachusetts, United States"},"metadata":null,"id":5232207008,"updated_at":"2026-05-27T09:38:36-04:00","requisition_id":"106","title":"Scientist, Downstream, Process Development and Manufacturing (PD/MFG) (Biologics)","company_name":"Oruka Therapeutics","first_published":"2026-05-27T09:38:36-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Us:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit \u0026lt;a href=\u0026quot;http://www.orukatx.com\u0026quot;\u0026gt;www.orukatx.com\u0026lt;/a\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As we build our core team, we\u0026#39;re seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.\u0026amp;nbsp; Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. \u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Job Title: \u0026lt;/strong\u0026gt;Scientist, Downstream, Process Development and Manufacturing (PD/MFG) (Biologics) \u0026amp;nbsp; \u0026amp;nbsp; \u0026amp;nbsp; \u0026amp;nbsp;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Location: \u0026lt;/strong\u0026gt;Hybrid – Waltham, MA\u0026lt;em\u0026gt;.\u0026lt;/em\u0026gt; Candidates will be required to be in-office\u0026amp;nbsp;3 days/week.\u0026lt;strong\u0026gt;\u0026amp;nbsp; \u0026amp;nbsp; \u0026amp;nbsp; \u0026amp;nbsp; \u0026amp;nbsp;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Role Overview: \u0026lt;/strong\u0026gt;We are seeking a motivated Process Development individual to lead downstream pre-clinical to early stage enabling process development, optimization, scale-up and transfer of manufacturing activities. In this role, the ideal candidate will be responsible for early-stage process development, tox batch production, optimization, scale up to GMP and late stage pivotal development. The successful candidate will be involved in pre-clinical development to pre-pivotal early-stage development in support of IND filing. This role involves working in a fast-paced environment and drafting high quality reports, finalization of source documents and active participation in writing regulatory submissions. You will be an integral part of a growing team with an opportunity to contribute towards developing best in class biotherapeutics. \u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Key Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Oversee the transfer of manufacturing processes from pre clinic to early-stage development to production at the CDMOs for multiple programs.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Work with CDMOs to identify gaps and implement improvements towards enhancing product quality, robustness, and cost-effectiveness with line of sight to clinical manufacturing.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Build strong relationships and partners cross-functionally with process development, analytical, formulation, quality, regulatory and program management.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Oversee tox production and GMP manufacturing campaigns ensuring seamless execution, timely completion and handoff to drug product manufacturing teams.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Serve as person-in-plant (PIP) during drug substance manufacturing campaigns.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Partner with stakeholders to support timely approval and execution of reports, batch records, in-process sampling plans, review SOPs, change controls, deviations, OOS/OOT investigations, and CAPAs.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support regulatory filings by authoring high quality reports enabling timely submissions for multiple jurisdictions (INDs, CTAs).\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;15-20% travel in support of manufacturing activities at CDMOs\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Bachelor’s or Master’s degree in Biochemistry, Biochemical Engineering, Biotechnology, or a related field.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Minimum of 4 years of relevant industry experience in the development, scale-up, and technology transfer of downstream processes for biologics.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Significant laboratory experience with early-stage development. Direct hands-on experience with monoclonal antibodies is a plus.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Expertise in purification process optimization with an emphasis on scale-up, process robustness, and facility fit.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Must have a solid understanding of all downstream unit operations, process parameters, product quality, and troubleshooting strategies enabling successful scale up.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Direct experience in design-of-experiments (DoE) and robust data analysis via industry standard statistical tools.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent writing, organization, communication and people management skills with the ability to work effectively with a diverse group of internal and external stakeholders.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Compensation:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;The anticipated salary range for candidates, who will work in 130,000 is $146,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;We\u0026#39;re looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Salary Range for the Role\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$130,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$146,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What We Offer:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Competitive salary and benefits package.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Opportunities for professional growth and development.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4017352008,"name":"CMC","child_ids":[],"parent_id":null}],"offices":[{"id":4008137008,"name":"Oruka Tx-Waltham, MA","location":"Waltham, Massachusetts, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/oruka/jobs/5192663008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_required","internal_job_id":4461444008,"location":{"name":"Remote; Waltham, Massachusetts, United States"},"metadata":null,"id":5192663008,"updated_at":"2026-04-29T11:30:00-04:00","requisition_id":"87","title":"Scientist/Senior Scientist, Upstream, Process Development \u0026 Manufacturing (Biologics)","company_name":"Oruka Therapeutics","first_published":"2026-04-17T15:11:44-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Us:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit \u0026lt;a href=\u0026quot;http://www.orukatx.com\u0026quot;\u0026gt;www.orukatx.com\u0026lt;/a\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As we build our core team, we\u0026#39;re seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.\u0026amp;nbsp; Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. \u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Job Title:\u0026amp;nbsp;\u0026lt;/strong\u0026gt;Scientist\u0026lt;strong\u0026gt;/\u0026lt;/strong\u0026gt;Senior Scientist, Upstream, Process Development \u0026amp;amp; Manufacturing (Biologics)\u0026amp;nbsp;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Location:\u0026amp;nbsp;Hybrid –\u0026amp;nbsp;\u0026lt;/strong\u0026gt;Waltham, MA required to be in-office 3 days/week -OR- Remote\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Position Overview:\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;We are seeking an experienced and motivated Scientist/Senior Scientist to support upstream manufacturing activities. This role will be instrumental in contributing to process development and delivery of clinical trial material at CDMOs. The ideal candidate will collaborate cross-functionally within the CMC team including downstream, analytical, and drug product and other stakeholders such as QA, regulatory, and program management. \u0026amp;nbsp;The successful candidate will help support CMC strategy in a fast-paced, innovative environment. You will be an integral part of a growing team with an opportunity to contribute towards developing best-in-class biotherapeutics.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Key Responsibilities\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Support cell culture process development and manufacturing activities at external CDMOs.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Execute and support upstream process development, scale-up, and tech transfer to enable drug substance supply.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Partner closely with CDMOs to execute fit‑for‑purpose upstream processes aligned with development timelines.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support planning and execution of drug substance manufacturing campaigns, including batch record review, sampling plans, deviations, investigations, and change management.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Serve as person‑in‑plant (PIP) during key manufacturing campaigns to support real‑time issue resolution.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Identify and mitigate technical and development risks using phase‑appropriate strategies.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Manage upstream timelines and deliverables to ensure on‑time material delivery and effective cross‑functional handoffs.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Apply phase‑appropriate QbD principles and analyze process data to support development decisions.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Contribute to upstream sections of regulatory submissions (INDs, IMPDs).\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Travel up to 20–25% to support CDMO activities.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Qualifications\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;PhD or Master’s degree in Engineering or Biological Sciences with\u0026amp;nbsp;~3-5 years\u0026amp;nbsp;of experience in upstream process development and/or manufacturing of biologics.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong hands‑on expertise in CHO cell culture process development, scale‑up, media optimization, and bioreactor operations; mAb experience preferred.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Solid understanding of upstream process parameters, product quality attributes, and troubleshooting in clinical manufacturing.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience supporting or leading upstream tech transfer to CDMOs.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Familiarity with phase‑appropriate cGMP and development regulatory expectations.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated ability to analyze and interpret process and manufacturing data.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Exposure to upstream process characterization (PC) and process performance qualification (PPQ) is a plus\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong written and verbal communication skills and ability to work effectively with cross‑functional and external partners.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Self‑motivated, execution‑focused, and comfortable operating in a fast‑paced, early‑stage biotech environment.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Compensation:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;The anticipated salary range for candidates is $130,000 to $208,000, who will work in Waltham, MA or remote if not living within commutable distance to Waltham. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;We\u0026#39;re looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Salary Range for the Role\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$130,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$208,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What We Offer:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Competitive salary and benefits package.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Opportunities for professional growth and development.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4017352008,"name":"CMC","child_ids":[],"parent_id":null}],"offices":[{"id":4008137008,"name":"Oruka Tx-Waltham, MA","location":"Waltham, Massachusetts, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/oruka/jobs/5250171008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_optional","internal_job_id":4487160008,"location":{"name":"Menlo Park, California, United States; Remote; Waltham, Massachusetts, United States"},"metadata":null,"id":5250171008,"updated_at":"2026-06-05T21:23:24-04:00","requisition_id":"116","title":"Senior Manager/Associate Director Clinical Monitoring Strategy \u0026 Optimization","company_name":"Oruka Therapeutics","first_published":"2026-06-05T21:23:24-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Us:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit \u0026lt;a href=\u0026quot;http://www.orukatx.com\u0026quot;\u0026gt;www.orukatx.com\u0026lt;/a\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As we build our core team, we\u0026#39;re seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.\u0026amp;nbsp; Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. \u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Job Title:\u0026amp;nbsp;\u0026amp;nbsp;\u0026amp;nbsp;\u0026amp;nbsp;\u0026amp;nbsp;\u0026amp;nbsp;\u0026amp;nbsp;\u0026amp;nbsp;\u0026amp;nbsp;\u0026amp;nbsp;\u0026amp;nbsp; Sr. Manager/Associate Director, Clinical Monitoring Strategy and Optimization\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Location: \u0026lt;/strong\u0026gt;Remote OR Hybrid 3 days/week if located near office in either Waltham, MA or Menlo Park, CA will be required.\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026amp;nbsp;\u0026amp;nbsp; \u0026amp;nbsp; \u0026amp;nbsp; \u0026amp;nbsp;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Role Overview:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;We are seeking an experienced and highly motivated Sr. Manager/Associate Director of Clinical Monitoring Strategy and Optimization to provide strategic and operational leadership for clinical monitoring activities across our development programs. This individual will play a critical role in building and scaling clinical operations infrastructure within a fast-paced emerging biotech environment.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The successful candidate will oversee CRO monitoring performance, ensure high-quality execution of clinical trials, and contribute to the development of monitoring processes, vendor oversight strategies, and inspection readiness activities. This role requires a hands-on leader who is comfortable operating both strategically and tactically in a lean organization.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Key Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;Clinical Monitoring Leadership\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Lead and oversee clinical monitoring activities for Phase 1–3 clinical trials conducted globally and/or domestically.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Serve as the internal expert for monitoring strategy, site management, and risk-based monitoring approaches.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide oversight and management of CROs, CRAs, and other external vendors to ensure quality, timelines, and budget adherence.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Review monitoring plans, trip reports, metrics, and monitoring deliverables for quality and compliance.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Partner cross-functionally with Clinical Development, Clinical Science, Data Management, Biostatistics, Medical Writing, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Vendor and CRO Oversight\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Establish effective CRO oversight and governance processes.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Monitor CRO performance through KPIs, metrics, and regular operational reviews.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Escalate and resolve study conduct issues proactively.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Participate in vendor selection, qualification, and contract review activities.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Trial Execution and Compliance\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Ensure studies are conducted in compliance with ICH-GCP, SOPs, protocol requirements, and applicable regulations.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support development and review of key study documents including Monitoring Plans, Risk Management Plans, Study Oversight Plans, Clinical Trial Management Plans, and Site Management Plans.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Contribute to inspection readiness activities and support regulatory inspections and audits.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Operational Process Development\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Help build scalable clinical monitoring infrastructure appropriate for a growing biotech company.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Develop and refine SOPs, work instructions, templates, and monitoring processes.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Drive continuous improvement initiatives focused on quality, efficiency, and operational excellence.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Implement and optimize risk-based monitoring methodologies and centralized monitoring approaches where appropriate.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Team Leadership and Mentorship\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;May directly manage CRAs and/or Clinical Trial Managers as the organization grows.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Mentor junior clinical operations staff and contribute to team development.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Foster a collaborative, accountable, and quality-focused culture.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Required\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Bachelor’s degree in life sciences, nursing, or related discipline.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;6-8+ years of clinical operations experience within biotech, pharmaceutical, or CRO environments.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Significant experience overseeing clinical monitoring activities in interventional clinical trials.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience managing CROs and external vendors.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated ability to work effectively in a small, fast-moving biotech environment.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent communication, organizational, and problem-solving skills.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Extensive domestic and international travel as needed (approximately 60-80%).\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;Preferred\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Bachelor’s degree or equivalent required.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Advanced degree (MS, MPH, PharmD, PhD, or RN) preferred.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience in rare disease, immunology, oncology, or other relevant therapeutic areas.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience supporting NDA/BLA-enabling studies and regulatory inspections.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience implementing risk-based monitoring strategies and oversight models.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Prior people management experience.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Desired Leadership Competencies\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Strategic thinker with strong execution skills\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Comfortable with ambiguity and rapid change\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Hands-on and solutions-oriented\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong collaborator and relationship builder\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;High attention to detail and commitment to quality\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to influence cross-functional teams and external partners\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Compensation: \u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;The anticipated salary range for Sr. Manager is $161,000 - $187,000 and for Associate Director level is $182,000 - $208,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer, and this salary range may not reflect positions that work in other states.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Location: \u0026lt;/strong\u0026gt;Remote OR Hybrid 3 days/week if located near office in either Waltham, MA or Menlo Park, CA will be required.\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026amp;nbsp;\u0026amp;nbsp; \u0026amp;nbsp; \u0026amp;nbsp; \u0026amp;nbsp;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;We\u0026#39;re looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Salary Range for the Role\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$161,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$208,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What We Offer:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Competitive salary and benefits package.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Opportunities for professional growth and development.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4017355008,"name":"Clinical Operations","child_ids":[],"parent_id":null}],"offices":[{"id":4008136008,"name":"Oruka Tx-Menlo Park","location":"Menlo Park, California, United States","child_ids":[],"parent_id":null},{"id":4008137008,"name":"Oruka Tx-Waltham, MA","location":"Waltham, Massachusetts, United States","child_ids":[],"parent_id":null},{"id":4014100008,"name":"Remote","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/oruka/jobs/5202169008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_required","internal_job_id":4465931008,"location":{"name":"Waltham, Massachusetts, United States"},"metadata":null,"id":5202169008,"updated_at":"2026-04-27T16:46:05-04:00","requisition_id":"92","title":"Senior Manager, Clinical Supply Chain (Biologics)","company_name":"Oruka Therapeutics","first_published":"2026-04-27T16:44:59-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Us:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit \u0026lt;a href=\u0026quot;http://www.orukatx.com\u0026quot;\u0026gt;www.orukatx.com\u0026lt;/a\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As we build our core team, we\u0026#39;re seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.\u0026amp;nbsp; Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. \u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Job Title: \u0026lt;/strong\u0026gt;Senior Manager, Clinical Supply Chain (Biologics) \u0026amp;nbsp; \u0026lt;strong\u0026gt;\u0026amp;nbsp; \u0026amp;nbsp; \u0026amp;nbsp;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Location: \u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;Hybrid – \u0026lt;/strong\u0026gt;Waltham, MA\u0026lt;strong\u0026gt;\u0026lt;em\u0026gt;.\u0026lt;/em\u0026gt;\u0026lt;/strong\u0026gt; Candidates will be required to be in-office\u0026amp;nbsp;3 days/week.\u0026lt;strong\u0026gt;\u0026amp;nbsp; \u0026amp;nbsp; \u0026amp;nbsp; \u0026amp;nbsp; \u0026amp;nbsp;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Role Overview: \u0026lt;/strong\u0026gt;We are seeking an experienced and motivated candidate to execute clinical supply chain activities in support of early-to-late-stage clinical trials. In this role, you will be responsible for overseeing labeling, packaging, distribution, inventory management, forecasting, IRT initiation, maintenance and expiry of clinical supplies. You are an ideal candidate for this role if you enjoy working in a fast-paced, high-touch environment establishing strong relationships across CMC, Clinical, Program Management, Regulatory and Quality. You will be reporting to and working alongside the head of Clinical Supply Chain to help establish Clinical Supplies processes and best practices, while supporting multiple clinical trials across US, Canada and EU. You are highly communicative and motivated to produce results effectively, efficiently and early to support global clinical supply chain activities in support of vials and pre-filled syringes.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Key Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Execute clinical supply chain activities including but not limited to labeling, packaging, distribution, inventory management, forecasting, IRT initiation, maintenance and expiry of clinical supplies\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Author, review and/or approve clinical labels, packaging batch records, shipping documents, stability, clinical study, and pharmacy protocols\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Serve as subject matter expert to generate label texts, distribution lanes, randomization codes, packaging specifications, and designs in compliance with regulations and GMPs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support site initiation visits (SIV), trials and OLEs by providing timely delivery of supplies, CoAs, stability, expiration, handling and destruction information\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Plan and adapt to changes against clinical demands, trial and protocol changes, expiration, and inventory management\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support clinical supply and logistics planning in support of global regulatory filings\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Liaise with stakeholders to support timely approval and execution of SOPs, batch records, lot releases, change controls, deviations, and CAPAs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support clinical distribution across US, Canada and EU through both IRT and manual driven site shipments and depot transfers\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Verify with Quality the accuracy within blinded studies’ drug release, shipments \u0026amp;amp; IRT setup\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Identify and execute process improvements through report development and SOPs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Build strong relationships and partners with other leaders across CMC, quality, clinical operations, regulatory, and external CDMO/CPOs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Serve as person-in-plant (PIP) during label and packaging campaigns\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;20-25% travel in support of diligence and campaign execution at the CPOs\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Bachelor’s or Master’s in a scientific discipline with 6+ years of relevant experience in clinical supply chain and logistics\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Must have hands-on experience managing supply chain activities including but not limited to labeling, packaging, distribution, inventory management, forecasting, IRT initiation, maintenance and expiry of clinical supplies\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with clinical supply chain involving cold chain products is a plus\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Exposure to support clinical supply activities involving vials or pre-filled syringes is a plus\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated experience managing import/export for clinical studies in US, Canada and EU\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong clinical supply skills with operational experience in tracking multiple activities, deliverables, timelines, contracts and budgets\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;In-depth knowledge of quality and regulatory aspects of clinical supply chain in support of simple to complicated multi country clinical studies\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated track record of successful tech transfers to commercial CPOs with an eye towards late stage and commercial launch\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent writing, organization, communication and people management skills with the ability to work effectively with a diverse group of internal and external stakeholders\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Must have a creative, organized and strategic attitude with the ability to work in a fast-paced environment\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Compensation:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;The anticipated salary range for candidates, who will work in Waltham, MA, is $161,0000 to $187,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;We\u0026#39;re looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Salary Range for the Role\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$161,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$187,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What We Offer:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Competitive salary and benefits package.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Opportunities for professional growth and development.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4017352008,"name":"CMC","child_ids":[],"parent_id":null}],"offices":[{"id":4008137008,"name":"Oruka Tx-Waltham, MA","location":"Waltham, Massachusetts, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/oruka/jobs/5229654008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_optional","internal_job_id":4479322008,"location":{"name":"Menlo Park, California, United States"},"metadata":null,"id":5229654008,"updated_at":"2026-06-03T12:42:57-04:00","requisition_id":"105","title":"Senior Paralegal/Senior Contracts Manager","company_name":"Oruka Therapeutics","first_published":"2026-05-22T17:02:59-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Us:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit \u0026lt;a href=\u0026quot;http://www.orukatx.com\u0026quot;\u0026gt;www.orukatx.com\u0026lt;/a\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As we build our core team, we\u0026#39;re seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.\u0026amp;nbsp; Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. \u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Job Title:\u0026amp;nbsp;\u0026amp;nbsp;\u0026amp;nbsp;\u0026amp;nbsp;\u0026amp;nbsp;\u0026amp;nbsp;\u0026amp;nbsp;\u0026amp;nbsp;\u0026amp;nbsp;\u0026amp;nbsp; Senior Paralegal/Senior Contracts Manager\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Location:\u0026amp;nbsp;\u0026amp;nbsp;\u0026amp;nbsp;\u0026amp;nbsp;\u0026amp;nbsp;\u0026amp;nbsp;\u0026amp;nbsp;\u0026amp;nbsp;\u0026amp;nbsp; Hybrid – Menlo Park, CA.\u0026amp;nbsp; Onsite 3 days/week\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Role Overview:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Our Senior Paralegal/Senior Contracts Manager will play a key role in managing day-to-day contracts and supporting a wide range of legal matters for a growing public biopharma company. This position is ideal for a proactive, highly organized professional who thrives in a fast-paced, collaborative environment. The ideal candidate will bring experience supporting small to mid-size legal departments, preferably within the life sciences industry, and be comfortable working across multiple projects with minimal supervision.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Key Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Manage the full contracts lifecycle, including intake, review, negotiation support, execution, and archiving.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Maintain and enhance contract management systems, tracking key dates, renewals, obligations, and reporting metrics as needed.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lead the continued development of the contract management system, including optimizing workflow, implementing process improvements, and partnering cross-functionally to enhance contracts operations.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Draft and review routine agreements, such as confidentiality agreements, clinical trial agreements, amendments, and statements of work.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Serve as a key liaison with internal teams, ensuring timely contract execution and providing guidance on legal processes and requirements.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support corporate governance matters, including maintaining corporate records, board materials, and managing state filings.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Assist with public company obligations, including securities filings, compliance initiatives, and corporate policies.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Help other legal functions such as IP as needed.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Contribute to special projects and provide additional legal support as assigned.\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;Qualifications:\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Education: Bachelor’s degree required; paralegal certificate or equivalent preferred.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience: 5–7+ years of paralegal or contracts management experience, with prior work in life sciences or biopharma strongly preferred; public company experience a plus.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Skills \u0026amp;amp; Competencies:\u0026lt;/li\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Excellent written and verbal communication skills.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong organizational skills, with the ability to manage multiple projects and meet deadlines.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated ability to work independently, exercise sound judgment, and proactively manage competing priorities.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Familiarity with contract management systems (SharePoint or similar).\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong business acumen and ability to partner effectively with cross-functional stakeholders.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Compensation:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;The anticipated salary range is $161,000 - $187,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Salary Range For the Role\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$161,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$187,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What We Offer:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Competitive salary and benefits package.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Opportunities for professional growth and development.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4017361008,"name":"Legal","child_ids":[],"parent_id":null}],"offices":[{"id":4008136008,"name":"Oruka Tx-Menlo Park","location":"Menlo Park, California, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/oruka/jobs/5202403008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_required","internal_job_id":4466052008,"location":{"name":"Remote"},"metadata":null,"id":5202403008,"updated_at":"2026-04-27T19:03:29-04:00","requisition_id":"93","title":"Senior Publications Manager","company_name":"Oruka Therapeutics","first_published":"2026-04-27T19:03:29-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Us:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit \u0026lt;a href=\u0026quot;http://www.orukatx.com\u0026quot;\u0026gt;www.orukatx.com\u0026lt;/a\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As we build our core team, we\u0026#39;re seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.\u0026amp;nbsp; Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. \u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Job Title: \u0026lt;/strong\u0026gt;Senior Publications Manager \u0026amp;nbsp; \u0026lt;strong\u0026gt;\u0026amp;nbsp; \u0026amp;nbsp; \u0026amp;nbsp;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Location: \u0026lt;/strong\u0026gt;Remote\u0026amp;nbsp;\u0026lt;strong\u0026gt; \u0026amp;nbsp; \u0026amp;nbsp; \u0026amp;nbsp; \u0026amp;nbsp;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Role Overview: \u0026lt;/strong\u0026gt;We are looking for a \u0026lt;strong\u0026gt;Senior Publications Manager\u0026lt;/strong\u0026gt; to lead publication planning and execution across our clinical and scientific programs. This role will be responsible for driving high-quality, timely development of manuscripts, abstracts, posters, and related scientific communications in close partnership with internal cross-functional teams and external medical writing vendors.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This is a highly collaborative, hands-on role for someone who understands the strategic importance of publications in biotech and can manage multiple deliverables across a fast-moving environment. The right person will be comfortable building processes, partnering with subject matter experts, and ensuring scientific outputs are accurate, compliant, and aligned with broader medical affairs and development objectives.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This role is ideal for someone who enjoys both strategy and execution and is excited to help build the publications function within a growing biotech company.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Key Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Publications Strategy and Planning\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Lead development and execution of publication plans aligned with company strategy, clinical milestones, and medical affairs objectives\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Partner with Medical Affairs, Clinical Development, Biostatistics, Regulatory, and other internal stakeholders to identify publication opportunities and priorities\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Help define publication strategy across manuscripts, abstracts, posters, congress presentations, and other scientific outputs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Maintain visibility into timelines, dependencies, and milestone-driven deliverables across programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Track relevant congress deadlines and publication opportunities to support proactive planning\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Publication Development and Execution\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Manage end-to-end development of scientific publications, including:\u0026lt;/li\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;manuscripts\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;review articles\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;abstracts\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;posters\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;oral presentations\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;encore materials, as appropriate\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;li\u0026gt;Coordinate author review, internal review, and approval workflows to support on-time delivery\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure materials accurately reflect scientific data and are consistent with agreed messaging and publication objectives\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Partner with internal subject matter experts to shape content direction, interpret data, and resolve comments efficiently\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support preparation for scientific congresses by driving abstract and poster development from concept through final delivery\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Oversee publication timelines, status trackers, and document version control\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Vendor and Agency Management\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Serve as the primary point of contact for external medical writing vendors and publications agencies\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Manage vendor scope, timelines, budgets, and deliverable quality\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide clear direction and feedback to vendors to ensure content meets scientific, stylistic, and strategic expectations\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Review drafts critically for scientific accuracy, clarity, completeness, and consistency\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Help establish productive, scalable ways of working with external writing partners\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Monitor vendor performance and help identify opportunities to improve efficiency, quality, and collaboration\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Process and Compliance\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Help build and refine publications processes\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure publication activities are conducted in accordance with internal policies, publication standards, and applicable industry guidelines\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support documentation of publication decisions, authorship rationale, and review history as needed\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Contribute to publication governance, tracking, and planning tools that improve transparency and execution\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Promote high standards for scientific integrity, authorship practices, and publication quality\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Required BA/BS in related discipline, a combination of relevant education and applicable job experience may be considered\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Advanced degree in life sciences preferred\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Experience in the dermatology or immunology therapeutic areas highly preferred.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;5+ years of relevant experience in publications, medical affairs, scientific communications, or medical writing within biotech, pharma, or a medical communications environment\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Knowledge of ICMJE recommendations, Good Publication Practice guidelines, and standard publication planning processes.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong experience managing scientific publications, including manuscripts, abstracts, and posters\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated experience working with and managing external medical writing vendors or publications agencies\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong understanding of publication planning, congress execution, and scientific data communication\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent project management skills with the ability to manage multiple complex deliverables simultaneously\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong written and verbal communication skills, including the ability to provide thoughtful editorial and strategic feedback\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;High attention to detail and commitment to scientific accuracy, quality, and compliance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to work cross-functionally and build strong relationships in a collaborative, fast-paced environment\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to operate with autonomy and help build processes where structure is still evolving\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;The ability to travel twice yearly to company all hands meetings and optionally to scientific conferences where presence is of value\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Compensation:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;The anticipated salary range for candidates, who will work remotely\u0026amp;nbsp;is $161,000 to $187,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;We\u0026#39;re looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Salary Range for the Role\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$161,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$187,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What We Offer:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Competitive salary and benefits package.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Opportunities for professional growth and development.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4017354008,"name":"Medical Affairs","child_ids":[],"parent_id":null}],"offices":[{"id":4008137008,"name":"Oruka Tx-Waltham, MA","location":"Waltham, Massachusetts, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/oruka/jobs/5202407008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_required","internal_job_id":4466056008,"location":{"name":"Menlo Park, California, United States; Remote; Waltham, Massachusetts, United States"},"metadata":null,"id":5202407008,"updated_at":"2026-05-20T18:04:02-04:00","requisition_id":"94","title":"Senior Scientific Communications Manager","company_name":"Oruka Therapeutics","first_published":"2026-04-27T19:24:21-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Us:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit \u0026lt;a href=\u0026quot;http://www.orukatx.com\u0026quot;\u0026gt;www.orukatx.com\u0026lt;/a\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As we build our core team, we\u0026#39;re seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.\u0026amp;nbsp; Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. \u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Job Title: \u0026lt;/strong\u0026gt;Senior Scientific Communications Manager\u0026amp;nbsp;\u0026amp;nbsp;\u0026lt;strong\u0026gt;\u0026amp;nbsp; \u0026amp;nbsp; \u0026amp;nbsp;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Location:\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;Remote OR Hybrid 3 days/week if located near office in either Waltham, MA or Menlo Park, CA will be required \u0026amp;nbsp;\u0026lt;strong\u0026gt; \u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Role Overview: \u0026lt;/strong\u0026gt;We’re looking for a \u0026lt;strong\u0026gt;Senior Scientific Communications Manager\u0026lt;/strong\u0026gt; to join our growing biotech team. This is a hands-on role for someone who enjoys turning complex scientific and clinical information into clear, accurate, and useful communications for a variety of audiences.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;At a small startup, this person will wear multiple hats. You’ll help shape our scientific story externally and internally, while also building and supporting core Medical Information capabilities. That means creating high-quality scientific materials and helping ensure that medical inquiries are addressed in a timely, accurate, balanced, and compliant way.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This role is a great fit for someone who is scientifically strong, highly organized, comfortable with ambiguity, and excited to build processes in a fast-moving environment.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Key Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Scientific Communications\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Develop and refine clear, compelling scientific messaging across programs and stages of development\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Draft and manage scientific content such as:\u0026lt;/li\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;slide decks\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;congress materials\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;medical Information letters\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;medical affairs and training materials\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;FAQs and background documents\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;external sci comm projects (e.g. webinars, podcast, product theaters, symposia)\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;li\u0026gt;Translate preclinical, translational, and clinical data into audience-appropriate communications\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Partner cross-functionally with Medical Affairs, Clinical Development, Regulatory, and company leadership to ensure scientific accuracy and message consistency\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Help prepare materials for advisory boards, investigator meetings, and scientific congresses\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Contribute to the development of the company’s scientific narrative as programs advance\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Medical Information\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Help build and maintain core Medical Information content and processes in an early-stage company environment\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Develop, review, and update standard medical response documents and reference materials\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Research and synthesize literature and internal data to support responses to unsolicited medical inquiries\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure responses are accurate, balanced, evidence-based, and compliant with internal and external requirements\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Partner with Medical Affairs, Regulatory, and Pharmacovigilance to support appropriate documentation and escalation of medical inquiries, adverse events, and product complaints, as applicable\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Maintain a library of response letters, FAQs, and scientific references\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Identify trends in incoming medical questions and share insights with internal stakeholders\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support training of internal teams on scientific messaging and Medical Information processes\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Help manage external Medical Information vendors or agency partners, when applicable\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Other Requirements\u0026lt;/strong\u0026gt;: the ability to travel at least twice yearly to company all hands meetings and optionally to scientific conferences where you feel your presence is of value\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Qualifications:\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Advanced degree in life sciences preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Approximately \u0026lt;strong\u0026gt;5+ years of relevant experience\u0026lt;/strong\u0026gt; in scientific communications, medical communications, medical affairs, medical information, or a related biotech/pharma function\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience in dermatology or immunology strongly preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong scientific writing and editing skills, with the ability to tailor content to different audiences\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Solid understanding of drug development, clinical research, and interpretation of scientific data\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience supporting scientific communications deliverables such as presentations and congress materials\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience developing or reviewing Medical Information content is strongly preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong attention to detail and commitment to scientific accuracy and compliance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Able to work independently, manage multiple priorities, and adapt quickly in a startup setting\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience working with vendors, medical writers, or outsourced contact center/Med Info partners\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaborative, practical, and comfortable working across functions with limited structure\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Required BA/BS in related discipline, a combination of relevant education and applicable job experience may be considered\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Advanced degree in life sciences preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience in the dermatology or immunology therapeutic areas highly preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;5+ years of relevant experience in publications, medical affairs, scientific communications, or medical writing within biotech, pharma, or a medical communications environment\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Knowledge of ICMJE recommendations, Good Publication Practice guidelines, and standard publication planning processes\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong experience managing scientific publications, including manuscripts, abstracts, and posters\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated experience working with and managing external medical writing vendors or publications agencies\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong understanding of publication planning, congress execution, and scientific data communication\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent project management skills with the ability to manage multiple complex deliverables simultaneously\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong written and verbal communication skills, including the ability to provide thoughtful editorial and strategic feedback\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;High attention to detail and commitment to scientific accuracy, quality, and compliance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to work cross-functionally and build strong relationships in a collaborative, fast-paced environment\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to operate with autonomy and help build processes where structure is still evolving\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;The ability to travel twice yearly to company all hands meetings and optionally to scientific conferences where presence is of value\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Compensation:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;The anticipated salary range for candidates, who will work remotely\u0026amp;nbsp;is $161,000 to $187,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;We\u0026#39;re looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Salary Range for the Role\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$161,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$187,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What We Offer:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Competitive salary and benefits package.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Opportunities for professional growth and development.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4017354008,"name":"Medical Affairs","child_ids":[],"parent_id":null}],"offices":[{"id":4014100008,"name":"Remote","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/oruka/jobs/5250377008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_required","internal_job_id":4487272008,"location":{"name":"Menlo Park, California, United States; Remote; Waltham, Massachusetts, United States"},"metadata":null,"id":5250377008,"updated_at":"2026-06-06T13:50:11-04:00","requisition_id":"117","title":"Sr. Manager/Associate Director, Regulatory Affairs","company_name":"Oruka Therapeutics","first_published":"2026-06-06T13:50:11-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Us:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit \u0026lt;a href=\u0026quot;http://www.orukatx.com\u0026quot;\u0026gt;www.orukatx.com\u0026lt;/a\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As we build our core team, we\u0026#39;re seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.\u0026amp;nbsp; Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. \u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Job Title: \u0026lt;/strong\u0026gt;Sr. Manager/Associate Director, Regulatory Affairs\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Location\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;:\u0026lt;/strong\u0026gt; Preferred: Hybrid 3 days/week in office (Menlo Park, CA or Waltham, MA). Remote will be considered.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Position Summary\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Senior Manager / Associate Director, Regulatory Affairs will support regulatory activities for one or more development programs and contribute to the development and execution of global regulatory plans that support the advancement of Oruka’s biologics portfolio. This individual will work closely with cross-functional teams to provide regulatory guidance throughout product development, support health authority interactions, and help ensure the timely preparation and submission of high-quality regulatory applications.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The successful candidate will be a collaborative partner who can balance strategic thinking with strong operational execution in a fast-paced biotechnology environment.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Key Responsibilities\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Regulatory Development Support\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Serve as a regulatory representative on multidisciplinary program teams for one or more investigational products\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Contribute to the development and execution of global regulatory plans aligned with program objectives and development timelines\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support regulatory planning across the product lifecycle, from early clinical development through registration planning and lifecycle management\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Evaluate regulatory precedent, guidance, and competitive intelligence to inform regulatory recommendations and development planning\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Partner closely with cross functional development team and program leadership to support development objectives and regulatory requirements\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support regulatory assessments related to development pathways, expedited programs, pediatric requirements, and regional filing considerations\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Health Authority Interactions\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Support the planning, preparation, and execution of health authority interactions, including FDA meetings, scientific advice procedures, and other agency engagements\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Contribute to the development of briefing documents, meeting requests, responses to regulatory questions, and other regulatory communications\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Participate in interactions with health authorities and support follow-up activities and action plans\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Help translate regulatory feedback into clear recommendations for cross-functional teams\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Submissions and Regulatory Execution\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Independently manage assigned regulatory submission activities, including preparation and coordination of INDs/CTAs and amendments, annual reports, investigator brochure updates, briefing packages, and other regulatory documents\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Contribute to major regulatory submissions and health authority deliverables for assigned development programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Coordinate submission planning, timelines, content development, and review activities\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Partner with Regulatory Operations and external vendors to support dossier planning, publishing, and electronic submissions\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure regulatory documents are scientifically accurate, compliant, and aligned with development objectives\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Regulatory Compliance\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Monitor and interpret global regulatory requirements, guidance documents, and policy developments relevant to assigned programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support compliance with applicable regulations, ICH guidelines, and company procedures\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Contribute to the development and continuous improvement of regulatory processes, templates, and SOPs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Assist with tracking and fulfillment of regulatory commitments\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Leadership and Collaboration\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Build strong partnerships across functional teams through effective communication and collaboration\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide regulatory input and risk-based recommendations to support cross-functional decision-making\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Qualifications\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Education\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Bachelor’s degree in a life sciences discipline required\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Advanced degree (MS, PharmD, PhD, or equivalent) preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;RAC certification is a plus\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Experience\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;8 - 10 years of progressive Regulatory Affairs experience in biotechnology or pharmaceutical development\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience supporting regulatory activities for drugs and/or biologics in clinical development, including health authority interactions and global submissions\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience authoring and/or coordinating regulatory submissions and agency briefing documents\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience in dermatology, immunology, inflammation, or related therapeutic areas is advantageous\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Skills\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Strong understanding of global regulatory requirements, including US/EU regulations, ICH guidelines, and ex-US development considerations for drugs and biologics\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to interpret regulatory guidance and apply it in a practical, risk-based manner\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent communication, collaboration, organizational, and project management skills\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong scientific and analytical thinking with the ability to connect regulatory requirements to development objectives\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to manage multiple priorities and work effectively in a dynamic environment\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Willingness to travel up to 20%\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Compensation:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;The anticipated salary range for the Senior Manager level is $161,000 - $187,000 and the Associate Director level is $182,000 - $208,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What We Offer\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Competitive salary and benefits package\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Eligibility for matching 401(k) and participation in ESPP\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Comprehensive health, dental, vision, and life insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Flexible working arrangements\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A collaborative, mission-driven culture\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;The opportunity to play a meaningful role in advancing a differentiated biologics portfolio with the potential to redefine treatment expectations for patients with chronic skin diseases\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;This role is ideal for a regulatory professional who enjoys working across multiple aspects of Regulatory Affairs and wants to play a meaningful role in advancing innovative therapies through clinical development and regulatory approval.\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Salary Range For the Role\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$161,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$208,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What We Offer:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Competitive salary and benefits package.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Opportunities for professional growth and development.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4017353008,"name":"Regulatory Affairs","child_ids":[],"parent_id":null}],"offices":[{"id":4008136008,"name":"Oruka Tx-Menlo Park","location":"Menlo Park, California, United States","child_ids":[],"parent_id":null},{"id":4008137008,"name":"Oruka Tx-Waltham, MA","location":"Waltham, Massachusetts, United States","child_ids":[],"parent_id":null},{"id":4014100008,"name":"Remote","location":null,"child_ids":[],"parent_id":null}]}],"meta":{"total":27}}