{"jobs":[{"absolute_url":"https://job-boards.greenhouse.io/kailera/jobs/5230971008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":4159286008,"location":{"name":"Waltham, Massachusetts"},"metadata":null,"id":5230971008,"updated_at":"2026-06-16T13:31:05-04:00","requisition_id":"188","title":"Associate Director, Analytical Development and Quality Control","company_name":"Kailera Therapeutics, Inc.","first_published":"2026-05-26T11:54:20-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. \u0026lt;br\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What You’ll Do:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Associate Director, Analytical Development and Quality Control will support analytical development and QC operations for clinical development and commercialization of Kailera’s pipeline compounds. The individual will provide technical expertise and will work closely with cross-functional stakeholders to ensure end-to-end drug development and manufacturing activities are executed seamlessly and in alignment with the company’s integrated development plans and program timelines.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Required location: Waltham, MA\u0026amp;nbsp;(hub-based, onsite 3-4 days per week)\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Support analytical development and QC activities related to characterization of peptide drug substances and drug products from early-stage clinical development through commercialization\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Maintain current knowledge in analytical methods and control strategies supporting a variety of molecule platforms and dosage forms\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support development of analytical methods that support Kailera’s product pipeline, including analytical transfers and troubleshooting in CDMO laboratories\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide input for developing and implementing analytical development strategies, including managing execution of functional activities in support of clinical development, regulatory filings (IND/NDA/MAA), product approvals, and commercialization\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support authoring of relevant CMC sections to enable global regulatory filings\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Participate on cross-functional CMC teams for the project(s) assigned to ensure adequate development and execution of CMC plan/strategies as needed\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Communicate CMC project status to key stakeholders cross-functionally and assist in driving decision-making\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaborate with cross-functional line functions to ensure CMC and program goals are met\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Travel to CDMOs and other service providers as needed for vendor technology transfers and analytical activities oversight\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Required Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;A bachelor’s degree and 10+ years of experience in the pharmaceutical/biotech industry with experience in all phases of innovative drug development and commercial launch in accordance with global CMC regulatory filings (IND/NDA/MAA, etc.)\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Or an advanced degree with 5+ years\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Knowledge of peptide chemistry is required\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated project and cross-functional team participation\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience in authoring regulatory documents\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Knowledge of drug development activities with respect to cGMP, quality systems, ICH guidelines, global regulatory requirements, and USP, EP, JP, and CHP requirements\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with oversight of the analytical activities at CDMOs and/or CTLs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Sound problem-solving skills with technically driven decision-making ability\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Effective written and verbal communication and interpersonal skills\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Innovative team-player with high energy for our dynamic company environment\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;Preferred Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Knowledge and experience in analytical development of peptide therapeutics (DS and DP)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Knowledge and experience in analytical development of injectable products, and associated control strategies\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;Education:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;A Bachelors degree with 10+ years or an advanced degree with 5+ years of relevant experience\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Degree in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, or closely related field.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Additional Information:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;This position requires some travel to domestic and international destinations\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;This position requires working in environments where there may be specific gowning or dress code requirements\u0026lt;/li\u0026gt;\n\u0026lt;/ul\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\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$155,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$190,000 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;For Full Time Roles:\u0026lt;/strong\u0026gt; This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;E-Verify:\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;color: rgb(255, 255, 255);\u0026quot;\u0026gt;\u0026amp;nbsp;#LI-Hybrid\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4036428008,"name":"Analytical Dev and QC","child_ids":[],"parent_id":null}],"offices":[{"id":4018220008,"name":"Massachusetts","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kailera/jobs/5230975008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":4380135008,"location":{"name":"Waltham, Massachusetts"},"metadata":null,"id":5230975008,"updated_at":"2026-06-16T13:31:05-04:00","requisition_id":"278","title":"Associate Director, Bioanalytical Sciences","company_name":"Kailera Therapeutics, Inc.","first_published":"2026-05-26T11:55:11-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. \u0026lt;br\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What You’ll Do:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Associate Director, Bioanalytical Sciences at Kailera Therapeutics will report to the Director, Bioanalytical Sciences and will be responsible for designing and executing bioanalytical strategies to support development programs for patients with obesity-related diseases. This role will oversee GLP-compliant bioanalytical work for non-clinical and clinical studies. The Associate Director will manage CRO-outsourced bioanalysis to advance drug candidates through various development stages while partnering with cross-functional teams to ensure the seamless integration of data into Kailera’s broader development programs.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Required location: Waltham, MA (hub-based, onsite 3-4 days per week)\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Lead bioanalytical strategy and execution in clinical and non-clinical studies\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaborate with cross-functional teams to design and implement bioanalytical aspects of clinical development programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Identify, select, and oversee CROs, ensuring adherence to timelines, budgets, and regulatory requirements\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Manage and oversee outsourced bioanalysis of small molecules, peptides, and biomarkers\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Direct the development, validation, and implementation of bioanalytical assays\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Review validation protocols, test procedures, raw data, and technical reports to ensure scientific rigor and compliance with regulatory guidelines\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide leadership in ensuring GLP compliance for bioanalysis in both non-clinical and clinical trials\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Author and review bioanalytical sections of regulatory submissions\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Represent the bioanalytical function in cross-functional project teams\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;Required Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;10+ years of relevant industry experience in bioanalytical sciences with a Bachelor’s degree or 5+ years with an advanced degree\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Expertise in regulated bioanalysis and clinical-stage drug development\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;In-depth knowledge of GLP/GCP requirements and industry best practices in bioanalytical laboratories\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proven experience in the regulatory requirements for method development and validation\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong track record of managing CRO-outsourced bioanalysis and vendor relationships\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent project management skills with the ability to manage multiple priorities effectively\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with regulatory interactions is highly desirable\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience contributing to regulatory filings for biologics and small molecules\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\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 GLP-1 receptor agonists or related therapeutic areas\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong understanding of bioanalytical considerations for incretin-based therapies\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;Education:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Bachelor\u0026#39;s degree in a relevant scientific discipline required (e.g., bioanalytical chemistry, pharmacology, or related field); PhD preferred\u0026lt;/li\u0026gt;\n\u0026lt;/ul\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\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$159,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$195,000 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;For Full Time Roles:\u0026lt;/strong\u0026gt; This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;E-Verify:\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;color: rgb(255, 255, 255);\u0026quot;\u0026gt;\u0026amp;nbsp;#LI-Hybrid\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4036418008,"name":"Non-Clinical","child_ids":[],"parent_id":null}],"offices":[{"id":4018220008,"name":"Massachusetts","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kailera/jobs/5252773008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":4379049008,"location":{"name":"Waltham, Massachusetts"},"metadata":null,"id":5252773008,"updated_at":"2026-06-16T13:31:05-04:00","requisition_id":"250","title":"Associate Director, Clinical Oversight","company_name":"Kailera Therapeutics, Inc.","first_published":"2026-06-09T14:42:19-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. \u0026lt;br\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What You’ll Do:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Associate Director, Clinical Oversight (ADCO) provides strategic leadership and operational direction for Clinical Monitoring Oversight across Kailera’s clinical development programs. This role is accountable for designing and executing a comprehensive oversight framework that ensures high-quality trial execution, regulatory compliance, and inspection readiness globally.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The ADCO serves as a senior leader and key partner to Clinical Operations, Quality, and external vendors, driving oversight strategy, performance management, and continuous improvement across studies and programs. This individual represents Kailera in oversight activities and plays a critical role in scaling processes, strengthening vendor governance, and advancing operational excellence.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Required location: Waltham, MA\u0026amp;nbsp;(hub-based, onsite 3-4 days per week)\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Define and lead the Clinical Monitoring Oversight strategy across studies, including development and oversight of Clinical Monitoring Oversight SOPs and templates, Clinical Oversight Monitoring plans, ensuring alignment with corporate goals, regulatory expectations, and evolving risk-based monitoring approaches\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Establish and continuously improve oversight SOPs, standards, tools, and governance models\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide executive oversight of clinical service providers (SPs), ensuring performance, quality, and compliance expectations are met\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Evaluates and provides recommendations to the study team on Oversight Service Provider activities to ensure the appropriate scope of work, oversight, and training of clinical oversight CRAs to achieve study milestones within agreed upon timelines, budget, and quality\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Oversee the planning and execution of clinical oversight visits and ensure consistent application of risk-based approaches\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provides oversight on service provider execution of clinical trial activities in accordance with Kailera SOPs, ICH Guidelines, and Good Clinical Practice (GCP)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Develops key performance indicators (KPIs) and evaluates service provider operational data against KPIs to proactively identify risks and drive data-informed decisions\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaborates with the Clinical Oversight team, Clinical Quality Management, and Clinical Study Team to implement corrective actions and monitor progress through resolution\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Facilitate resolution of region specific and site management related challenges\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Acts on behalf of Business Operations on cross-functional project teams; interacts with internal and external groups\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Assist with creation and delivery of department initiatives, improvement plans and/or training\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lead, mentor, and develop a high-performing global team of Clinical Oversight professionals\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Establish clear performance expectations and foster a culture of accountability, collaboration, and continuous improvement in accordance with applicable SOPs, regulations, GCP, Key Performance Indicators (KPIs), and study-specific requirements\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure robust oversight of data integrity, subject safety, and protocol compliance at investigator sites\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lead and contribute to inspection readiness activities, audits, and regulatory interactions as needed\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Conduct periodic quality visits for Oversight CRAs, as needed\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure the oversight CRAs are reviewing and ensuring data integrity, accuracy, and completeness at the clinical study sites\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Review contracts and approve vendor invoices\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;ul\u0026gt;\n\u0026lt;li\u0026gt;10+ years of clinical trial experience with significant leadership experience in clinical oversight, monitoring, or operations\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated expertise with Phase I–III clinical trials, risk-based monitoring, and CRA Management\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proficient in oversight tools and systems (CTMS, eTMF, dashboards, Microsoft Office)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong experience with Vendor oversight, KPI tracking, and issue management\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proven ability to lead and develop high-performing teams in a complex, fast-paced environment\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent organizational, analytical, and interpersonal skills; able to work independently and in teams\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong strategic thinking, problem-solving, and decision-making capabilities\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent communication, influencing, and stakeholder management skills\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proficiency with clinical systems (CTMS, eTMF, dashboards, Microsoft Office)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to travel as needed\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;Education:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Bachelor’s degree in a scientific or healthcare-related field\u0026lt;/li\u0026gt;\n\u0026lt;/ul\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\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$159,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$195,000 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;For Full Time Roles:\u0026lt;/strong\u0026gt; This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;E-Verify:\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;color: rgb(255, 255, 255);\u0026quot;\u0026gt;\u0026amp;nbsp;#LI-Hybrid\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4036420008,"name":"Clinical Dev Ops","child_ids":[],"parent_id":null}],"offices":[{"id":4018220008,"name":"Massachusetts","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kailera/jobs/5230977008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":4380164008,"location":{"name":"Waltham, Massachusetts"},"metadata":null,"id":5230977008,"updated_at":"2026-06-16T13:31:05-04:00","requisition_id":"290","title":"Associate Director, Clinical Quality Assurance","company_name":"Kailera Therapeutics, Inc.","first_published":"2026-05-26T11:56:01-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. \u0026lt;br\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Oversee and ensure compliance with GCP/GVP regulations, guidelines, and internal policies throughout clinical trial and pharmacovigilance activities\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Develop and implement quality assurance plans and strategies for clinical studies and related activities\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;In collaboration with internal stakeholders, ensure risk-based quality management is applied as appropriate to specific studies (e.g. through helping to facilitate the identification of critical data and critical data processes, and risks associated with them, establishing, monitoring and reporting out on Quality Tolerance Limits (QTLS))\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Monitor and track quality metrics to identify trends and areas of improvement\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure the timely completion of quality assurance activities, including audits, investigations, and inspection readiness\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Facilitate review of potential Serious Breach and Urgent Safety Measure assessments arising from clinical program\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Plan, coordinate, review and approve internal, external, and clinical site audits using risk-informed strategy to ensure GCP/GVP compliance in clinical studies and pharmacovigilance operations\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Assess audit findings and develop corrective and preventative actions (CAPA)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lead investigations into quality issues and deviations, identifying root causes and implementing appropriate CAPA\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure that investigations are conducted in a timely and thorough manner, following established procedures\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Develop and implement inspection readiness plans and procedures, ensuring that clinical studies and related activities are ready for Health Authority inspections\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide guidance and support to cross-functional teams during Health Authority inspections\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaborate with cross-functional teams to support data integrity during audits, inspections and clinical trial activities by adhering to GxPs standards and applicable regulations governing clinical data\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide training and guidance to cross-functional teams on GCP/GVP regulations, Quality Assurance procedures, and audit protocols\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Serve as a subject matter expert on GCP/GVP quality assurance matters\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Participate in the selection and evaluation of Vendors, ensuring that they meet quality standards and regulatory requirements\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Review and approve GCP/GVP-related documentation, including study protocols, study reports, and other relevant documents\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure that documentation is accurate, complete, and compliant with regulations\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Facilitate/participate in Quality Oversight Committee meetings with Vendors and develop and maintain quality agreements with Vendors\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;ul\u0026gt;\n\u0026lt;li\u0026gt;Minimum of 10 or more years of experience in FDA regulated industry\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Previous hands-on experience with Veeva Quality Docs, Veeva Training, and Veeva QMS required\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A strong customer focus and ability to prioritize and adapt to business needs are required\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong business partner with a focus on collaborating and delivering results\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Self-motivated, detail oriented, well organized, and able to demonstrate success with managing multiple projects simultaneously and other priorities\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Understanding and knowledge of applicable industry regulations\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to interact constructively and efficiently within and across functional areas and management\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to resolve day-to-day issues efficiently while maintaining compliance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Clear, concise writing skills and good verbal communication and presentation skills\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proficiency in Microsoft Word, Power Point, Excel, Adobe, and SharePoint\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Comply with Company quality standards/SOPs and implementation of new quality systems\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide imaginative, thorough, and practical solutions to problems\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Solve conflict and address workplace issues in a professional and collaborative manner\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\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 required\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\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$155,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$190,000 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;For Full Time Roles:\u0026lt;/strong\u0026gt; This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;E-Verify:\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;color: rgb(255, 255, 255);\u0026quot;\u0026gt;\u0026amp;nbsp;#LI-Hybrid\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4036430008,"name":"Quality","child_ids":[],"parent_id":null}],"offices":[{"id":4018220008,"name":"Massachusetts","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kailera/jobs/5127479008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":4380089008,"location":{"name":"Waltham, Massachusetts"},"metadata":null,"id":5127479008,"updated_at":"2026-06-16T13:31:05-04:00","requisition_id":"268","title":"Associate Director, Device Engineering","company_name":"Kailera Therapeutics, Inc.","first_published":"2026-02-20T15:00:32-05:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. \u0026lt;br\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What You’ll Do:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;We are seeking an experienced Associate Director, Device Engineering, to lead the development and launch of drug-device combination products, with a strong emphasis on autoinjectors, pre-filled syringes, and multidose pens. This role will drive cross-functional collaboration across CMC, quality, regulatory, manufacturing, clinical, and commercial teams to ensure robust product development aligned with meeting patient needs, global standards, and regulatory expectations.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Required location: Waltham, MA (hub-based, onsite 3-4 days per week)\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Lead combination product development projects (prefilled syringes, autoinjectors, and/or multidose pens) from concept through commercialization\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Build and execute project plans with clearly defined risks and milestones\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Develop device and combination product requirements, including user and stakeholder needs and technical requirements, and ensure appropriate engineering translation and subsequent verification and validation of requirements\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Oversee and ensure compliance with design controls per FDA and ISO 13485 requirements\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Manage risk management activities in accordance with ISO 14971, including hazard analysis, FMEA, and risk mitigation strategies\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Drive design verification and validation activities, including test method development, protocol execution, and documentation\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Oversee human factors and usability engineering efforts, ensuring compliance with FDA guidance and IEC 62366\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Facilitate design transfer to manufacturing, ensuring smooth transition and scalability\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Partner cross-functionally with CMC, quality, regulatory, clinical development, commercial/marketing, supply chain, and other key functions to ensure critical inputs are integrated into device development activities\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Author relevant portions of regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for devices and combination product programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Manage and collaborate with vendors, including Contract Design and Manufacturing Organizations (CDMOs) and suppliers, to ensure components and products meet quality and technical requirements and to integrate deliverables into the project Design History File at various stages of development and manufacturing\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Manage and collaborate with contract test labs to ensure testing strategy, method validation, and test execution are aligned with relevant standards and quality and technical requirements and integrate testing results into the Design History File\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure product development aligns with relevant standards including ISO 11608-1, ISO 11040, ASTM D4169, ISO 14971, IEC 62366\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Required Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Minimum of 10+ years of experience in medical device or combination product development, with at least 3 years in a team leadership role\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proven experience with autoinjector, pre-filled syringe, or multidose pen development and launch, including authoring clinical and commercial regulatory submissions\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Deep understanding of design controls, design verification, test method development and validation, risk management, human factors, and design transfer\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong knowledge of applicable regulatory standards and guidance documents\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent communication, leadership, and cross-functional collaboration skills\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;Preferred Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Experience working in a regulated pharmaceutical or biotech environment\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Familiarity with combination product regulations (21 CFR Part 4)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with supplier management of external development, testing, and manufacturing partners\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;PMP certification or formal project management training is a plus\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\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 mechanical engineering, Biomedical Engineering, or related field. Advanced degree preferred.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\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\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$159,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$195,000 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;For Full Time Roles:\u0026lt;/strong\u0026gt; This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;E-Verify:\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;color: rgb(255, 255, 255);\u0026quot;\u0026gt;\u0026amp;nbsp;#LI-Hybrid\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4036426008,"name":"Drug Product","child_ids":[],"parent_id":null}],"offices":[{"id":4018220008,"name":"Massachusetts","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kailera/jobs/5230981008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":4379005008,"location":{"name":"Waltham, Massachusetts"},"metadata":null,"id":5230981008,"updated_at":"2026-06-16T13:31:05-04:00","requisition_id":"240","title":"Associate Director/Director, Program Management (Regulatory Submissions)","company_name":"Kailera Therapeutics, Inc.","first_published":"2026-05-26T11:58:05-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. \u0026lt;br\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What You’ll Do:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Associate Director/Director, Program Management will collaborate with cross-functional teams, including clinical, regulatory, non-clinical, and technical operations, to lead regional and global cross-functional teams in the planning, preparation, and delivery of compliant marketing authorization filings. This individual will oversee the development and execution of project plans from initiation to completion, ensuring the plan is completed on time, in scope, and within budget. Additionally, they will work closely with teams to proactively identify potential risks and implement effective solutions. A successful candidate must have experience managing drug development projects, particularly initial marketing authorization applications, in a fast-paced environment, with a strong willingness to build relationships with cross-functional teams, dive into details, and address gaps as needed to ensure program success.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Required location: Waltham, MA\u0026amp;nbsp;(hub-based, onsite 3-4 days per week)\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Contribute to and lead the execution of submission strategies in alignment with corporate objectives and regulatory requirements\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lead and manage cross-functional submission team meetings and workstreams (Regulatory, Clinical, Quality, CMC, Medical Writing)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Oversee project team delivery of the marketing authorization applications\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Develop and own detailed integrated marketing authorization plans, including goals, deliverables, timelines, and resource requirements\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Monitor project progress and provide regular updates to Program Leader and other stakeholders, ensuring clear communication and transparency\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Own program reports / dashboards to executive and other governance teams\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Establish best practices and SOPs as needed for marketing application related submission processes\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\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;Required Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;10+ years of relevant experience of project management experience in the biotech, pharmaceutical, or life sciences industry\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong understanding of drug development and how biotech functions integrate\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience in managing cross-functional teams and complex projects inate-stage drug development, with experience managing global marketing authorization submissions (NDA, BLA, MAA) preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated project management and interpersonal skills\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent problem-solving and organizational skills, attention to detail, and analytical skills\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to manage multiple priorities in a fast-paced, dynamic environment\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Comfortable navigating ambiguity and driving clarity\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Responds to changing priorities and uncertainty by maintaining composure, resilience, and an open mind while embracing change in an evolving environment\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proven record of collaboration and excellent communication\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proficient in project management tools (e.g., Smartsheet, MS Project, Excel, think-cell, OnePager)\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;Education:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Bachelor’s degree in science, engineering, or a related field; advanced degree preferred\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Associate Director: advanced degree 5+ years of experience\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Director: advanced degree 8+ years of experience\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;This role may be hired at the Associate Director or Director level depending on candidate experience or business need.\u0026lt;/em\u0026gt;\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\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$155,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$190,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Salary Range (Associate Director)\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$155,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$190,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Salary Range (Director)\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$192,000\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;For Full Time Roles:\u0026lt;/strong\u0026gt; This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;E-Verify:\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;color: rgb(255, 255, 255);\u0026quot;\u0026gt;\u0026amp;nbsp;#LI-Hybrid\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4036406008,"name":"Program Management","child_ids":[],"parent_id":null}],"offices":[{"id":4018220008,"name":"Massachusetts","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kailera/jobs/5230986008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":4380187008,"location":{"name":"Waltham, Massachusetts"},"metadata":null,"id":5230986008,"updated_at":"2026-06-16T13:31:05-04:00","requisition_id":"296","title":"Associate Director, Program Management","company_name":"Kailera Therapeutics, Inc.","first_published":"2026-05-26T11:58:58-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. \u0026lt;br\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What You’ll Do:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Associate Director, Program Management will collaborate with cross-functional teams, including clinical, regulatory, non-clinical, and technical operations, to drive the overall program and several ad hoc projects forward. This individual will oversee the development and execution of project plans from initiation to completion, ensuring the plan is completed on time, in scope, and within budget. Additionally, they will work closely with teams to proactively identify potential risks and implement effective solutions. A successful candidate must have experience managing drug development projects in a fast-paced environment, with a strong willingness to build relationships with cross-functional teams, dive into details, and address gaps as needed to ensure program success.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Required location: Waltham, MA\u0026amp;nbsp;(hub-based, onsite 3-4 days per week)\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Support the Program Leader with planning, execution, and delivery of multiple projects across asset development\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaborate with cross-functional teams (e.g. clinical, regulatory, nonclinical, and technical operations, etc.) to ensure alignment with company and program objectives\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaborate with Program Leader to ensure agenda topics and outputs are aligned with the overall strategic development plan for the program\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Develop and own detailed integrated project plans, including goals, deliverables, timelines, and resource requirements\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Identify and manage program risks, issues, and dependencies, and proactively implement mitigation strategies\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Monitor project progress and provide regular updates to Program Leader and other stakeholders, ensuring clear communication and transparency\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Own program reports / dashboards to executive and other governance teams\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;Required Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;10+ years of relevant experience or at least 8 years with an advanced degree of project management experience in the biotech, pharmaceutical, or life sciences industry\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong understanding of drug development and how biotech functions integrate\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience in managing cross-functional teams and complex projects, with late-stage drug development experience preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated project management and interpersonal skills\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent problem-solving and organizational skills, attention to detail, and analytical skills\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to manage multiple priorities in a fast-paced, dynamic environment\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Comfortable navigating ambiguity and driving clarity\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Responds to changing priorities and uncertainty by maintaining composure, resilience, and an open mind while embracing change in an evolving environment\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proven record of collaboration and excellent communication\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proficient in project management tools (e.g., Smartsheet, MS Project, Excel, think-cell, OnePager)\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;Education:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Bachelor’s degree in science, engineering, or a related field; advanced degree preferred\u0026lt;/li\u0026gt;\n\u0026lt;/ul\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\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$159,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$195,000 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;For Full Time Roles:\u0026lt;/strong\u0026gt; This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;E-Verify:\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;color: rgb(255, 255, 255);\u0026quot;\u0026gt;\u0026amp;nbsp;#LI-Hybrid\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4036406008,"name":"Program Management","child_ids":[],"parent_id":null}],"offices":[{"id":4018220008,"name":"Massachusetts","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kailera/jobs/5230991008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":4380208008,"location":{"name":"Waltham, Massachusetts"},"metadata":null,"id":5230991008,"updated_at":"2026-06-16T13:31:05-04:00","requisition_id":"301","title":"Associate Director, Scientific Communications","company_name":"Kailera Therapeutics, Inc.","first_published":"2026-05-26T11:59:47-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. \u0026lt;br\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What You’ll Do:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Associate Director, Scientific Communications is responsible for leading the strategic planning, development, and execution of high‑quality scientific communications that advance Kailera’s Medical Affairs objectives. As a key member of a highly collaborative and fast-moving team, this individual will shape scientific narratives, drive publication strategy, and ensure the delivery of clear, accurate, and impactful scientific communication materials.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Required location: Waltham, MA\u0026amp;nbsp;(hub-based, onsite 3-4 days per week)\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Provide strategic leadership for scientific communications across our portfolio of assets, including publications, field medical resources, medical symposia content, and internal/external training materials\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lead cross‑functional planning discussions and oversee timely development of scientific communications deliverables in a dynamic, fast‑paced environment\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Manage external agencies, writers, and vendors to ensure high‑quality, cost‑effective execution aligned with program strategy\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure all materials are scientifically rigorous, accurate, balanced, compliant, and consistent with Kailera policies and industry standards (e.g. GPP, ICMJE)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Contribute to the evolution of scientific platforms, lexicons, and communication frameworks that support Kailera’s growing pipeline\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Represent Scientific Communications in internal governance discussions and support preparation for scientific congresses and external engagements\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Required Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;At least 5+ years of relevant experience in Scientific Communications within Medical Affairs or a medical communications agency with an advanced degree\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated experience in scientific publications and/or medical communications is required\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent interpersonal, analytical, and communication skills, with the ability to incorporate feedback from diverse stakeholders\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong planning and organizational capabilities; able to manage multiple priorities and thrive in a fast-paced environment\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to travel to scientific meetings as needed (up to ~10%)\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\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 in the obesity therapeutic area or adjacent metabolic/endocrine fields is preferred, but not required\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;CMPP certification is not required, but is a plus\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Education:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Advanced degree (PharmD, MD, PhD preferred) in the life/health sciences\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\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$159,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$195,000 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;For Full Time Roles:\u0026lt;/strong\u0026gt; This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;E-Verify:\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;color: rgb(255, 255, 255);\u0026quot;\u0026gt;\u0026amp;nbsp;#LI-Hybrid\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4036423008,"name":"Medical Affairs","child_ids":[],"parent_id":null}],"offices":[{"id":4018220008,"name":"Massachusetts","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kailera/jobs/5230997008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":4379031008,"location":{"name":"Waltham, Massachusetts"},"metadata":null,"id":5230997008,"updated_at":"2026-06-16T13:31:05-04:00","requisition_id":"246","title":"Associate Director, SEC Reporting \u0026 Technical Accounting","company_name":"Kailera Therapeutics, Inc.","first_published":"2026-05-26T12:01:14-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. \u0026lt;br\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What You’ll Do:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This role offers an exciting opportunity to join a fast-paced, talented, and growing organization as the Associate Director, SEC Reporting and Technical Accounting.\u0026amp;nbsp;This role will report directly to the Vice President, Corporate Controller and be responsible for providing technical expertise and support for the SEC filing, compliance related reporting, internal controls compliance program, and technical accounting functions for a company that recently closed an IPO. This role will partner directly with accounting staff, legal, and other stakeholders across the organization. This role is a “hands-on” position and will require critical thinking skills, strong attention to detail, and excellent written communication skills. The successful applicant will have the opportunity to leverage a strong background in technical accounting and SEC reporting to enhance the Company’s compliance and reporting capabilities.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Required location: Waltham, MA\u0026amp;nbsp;(hub-based, onsite 3-4 days per week)\u0026lt;/em\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;Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Lead the preparation, review, and filing of all SEC reports, including Forms 10‑K, 10‑Q, 8‑K, proxy statements, and other registration statements, ensuring accuracy, completeness, and timeliness\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Serve as a technical accounting subject‑matter expert, providing guidance on complex accounting matters under U.S. GAAP\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Prepare and review technical accounting memoranda supporting significant or non‑routine transactions and key accounting judgments\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Monitor and assess the impact of new accounting standards and SEC rules; lead implementation efforts and updates to accounting policies and disclosures\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Partner closely with external auditors to support quarterly reviews, annual audits, and the review of other public filings\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Coordinate cross‑functionally with Legal, FP\u0026amp;amp;A, Investor Relations, and external counsel on disclosure matters and public filings\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Prepare materials and run disclosure committee meetings with key stakeholders to ensure timely and accurate public disclosures\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Oversee the EDGARization and XBRL tagging processes, ensuring compliance with SEC requirements and consistency across filings\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Serve as the primary point of contact for all aspects of the Company’s SOX compliance program, including ownership of risk assessment, scoping, documentation, testing coordination, remediation of control deficiencies, and ongoing communication with internal stakeholders and external auditors to ensure effective internal controls over financial reporting\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide accounting support for special projects and ad-hoc reporting and analysis, as necessary\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Required Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;10+ years of progressive experience in public accounting and/or SEC reporting and technical accounting roles with a Bachelor’s degree or 5+ years of experience with an advanced degree\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Advanced knowledge of U.S. GAAP, SEC reporting requirements, financial statement disclosures, and internal controls\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Hands‑on experience preparing and reviewing SEC filings and working directly with external auditors and advisors\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong ability to research, interpret, and apply accounting literature to complex transactions\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong, hands-on experience with IT and financial systems, leveraging ERP platforms, SEC reporting and disclosure tools, and financial reporting systems to support accurate reporting, SOX compliance, data integrity, and efficient close and reporting processes\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proven project‑management skills with the ability to manage multiple deadlines in a fast‑paced environment\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent written and verbal communication skills, with the ability to clearly explain complex accounting matters to non‑technical stakeholders\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;High attention to detail, strong analytical skills, and sound professional judgment\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong team player that has a customer service approach and is solutions oriented\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Pharmaceutical or life science experience preferred\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;Education:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Bachelor’s degree in Accounting, Finance, or a related field required\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Master’s degree in Accounting, Finance, or Business Administration preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Current CPA license required\u0026lt;/li\u0026gt;\n\u0026lt;/ul\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\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$155,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$190,000 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;For Full Time Roles:\u0026lt;/strong\u0026gt; This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;E-Verify:\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;color: rgb(255, 255, 255);\u0026quot;\u0026gt;\u0026amp;nbsp;#LI-Hybrid\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4036409008,"name":"Finance","child_ids":[],"parent_id":null}],"offices":[{"id":4018220008,"name":"Massachusetts","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kailera/jobs/5230998008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":4379071008,"location":{"name":"Waltham, Massachusetts"},"metadata":null,"id":5230998008,"updated_at":"2026-06-16T13:31:05-04:00","requisition_id":"253","title":"Associate Director, Statistical Programming ","company_name":"Kailera Therapeutics, Inc.","first_published":"2026-05-26T12:01:19-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. \u0026lt;br\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What You’ll Do:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;We are seeking an experienced programmer to join us as Associate Director, Statistical Programming. This is a critical role responsible for leading statistical programming activities on the assigned disease area(s). This role will support clinical trials, regulatory submissions, and other key initiatives.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Required location: Waltham, MA\u0026amp;nbsp;(hub-based, onsite 3-4 days per week)\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Lead statistical programming efforts for clinical studies, including the development and review of programming specifications to ensure clarity, integrity, and compliance with internal and external standards\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lead the execution of ad-hoc and post-hoc analyses to support emerging clinical questions, publications, and internal decision-making\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Oversee and coordinate activities with Contract Research Organizations (CROs), focusing on the implementation of CDISC standards, creation of SDTM, ADaM datasets, and TFLs, and ensuring high-quality deliverables\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Conduct independent validation and quality checks of statistical programming deliverables from CROs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaborate closely with statisticians and cross-functional study teams to deliver results in a timely and accurate manner\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Manage multiple projects simultaneously, ensuring tasks are prioritized effectively to meet deadlines\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Required Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Proven hands-on experience in programming for clinical development, preferably in a leadership role, with a strong preference for late-phase clinical trial support\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience in regulatory submissions, including NDAs, BLAs, and other filings, with experience in ISS/ISE highly desirable\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Expertise in SAS programming and comprehensive knowledge of CDISC standards\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Familiarity with ICH/GCP guidelines and global regulatory submission requirements (e.g., FDA, EMA)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Extensive experience overseeing CROs, including independent validation of datasets and statistical deliverables\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Preferred Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Background in cardiometabolic diseases or related therapeutic areas is preferred\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;Education:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Advanced degree (MS/PhD) in Biostatistics, Statistics, or a related field\u0026lt;/li\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;MS\u0026lt;/strong\u0026gt;: Minimum of 8+ years of relevant experience\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;PhD\u0026lt;/strong\u0026gt;: Minimum of 6+ years of relevant experience\u0026lt;/li\u0026gt;\n\u0026lt;/ul\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\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$159,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$195,000 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;For Full Time Roles:\u0026lt;/strong\u0026gt; This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;E-Verify:\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;color: rgb(255, 255, 255);\u0026quot;\u0026gt;\u0026amp;nbsp;#LI-Hybrid\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4036421008,"name":"Biometrics","child_ids":[],"parent_id":null}],"offices":[{"id":4018220008,"name":"Massachusetts","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kailera/jobs/5230999008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":4379066008,"location":{"name":"Waltham, Massachusetts"},"metadata":null,"id":5230999008,"updated_at":"2026-06-16T13:31:05-04:00","requisition_id":"252","title":"Director, Clinical Scientist","company_name":"Kailera Therapeutics, Inc.","first_published":"2026-05-26T12:01:24-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. \u0026lt;br\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What You’ll Do:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Director, Clinical Scientist is a senior, hands-on scientific leader responsible for the scientific execution of clinical trials. This role partners closely with Clinical Operations and cross-functional teams to ensure high-quality trial conduct, rigorous data review, and clear scientific communication from study start-up through reporting.\u0026lt;br\u0026gt;\u0026lt;br\u0026gt;This position requires deep clinical trial experience, strong organizational skills, and comfort working directly in trial data. An MD is not required for this role.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Required location: Waltham, MA (hub-based, onsite 3-4 days per week)\u0026lt;/em\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;Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Support the Medical lead for one or more Phase I–III clinical studies\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support studies across the full trial lifecycle, from start-up through database lock and reporting\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lead ongoing review of clinical trial data listings, including adverse events, laboratory data, concomitant medications, vitals, ECGs, and safety outputs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Identify data trends, inconsistencies, and potential issues; partner with Data Management, Biostatistics, and Safety to resolve them\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Act as a close scientific partner to Clinical Operations to deliver on trial execution\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaborate effectively with cross-functional teams including Clinical Operations, Data Management, Biostatistics, Programming, Safety, and Regulatory\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Author, review, and contribute to trial documents, such as protocols, amendments, Investigator’s Brochures, and Clinical Study Reports\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Develop and deliver clear, well-structured presentations to study teams and internal leadership\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Drive execution, follow-through, and accountability across multiple concurrent deliverables\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Be flexible with travel and attend site related clinical development activities; form and maintain relationships with KOL’s\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Required Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;8+ years of extensive hands-on experience supporting clinical trials in a clinical development role\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated experience reviewing and interpreting clinical trial data listings\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong understanding of clinical trial conduct and cross-functional trial workflows\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proven ability to partner effectively with Clinical Operations\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Exceptional organizational, prioritization, and execution skills\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong written and verbal communication skills\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Advanced PowerPoint skills; working knowledge of Excel and other commonly used clinical systems/tools\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to manage multiple studies and deadlines 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;\u0026lt;strong\u0026gt;Education:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Advanced degree in life sciences discipline (PhD, PharmD, MS, or equivalent)\u0026lt;/li\u0026gt;\n\u0026lt;/ul\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\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$196,000\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;For Full Time Roles:\u0026lt;/strong\u0026gt; This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;E-Verify:\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;color: rgb(255, 255, 255);\u0026quot;\u0026gt;\u0026amp;nbsp;#LI-Hybrid\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4036419008,"name":"Clinical Development","child_ids":[],"parent_id":null}],"offices":[{"id":4018220008,"name":"Massachusetts","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kailera/jobs/5231066008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":4380163008,"location":{"name":"Waltham, Massachusetts"},"metadata":null,"id":5231066008,"updated_at":"2026-06-16T13:31:05-04:00","requisition_id":"289","title":"Manager, GxP Quality Systems","company_name":"Kailera Therapeutics, Inc.","first_published":"2026-05-26T12:18:26-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. \u0026lt;br\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What You’ll Do:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Manager of GxP Quality Systems will support Quality Management System processes, procedures, systems, training, and tools, ensuring quality and compliance are achieved and maintained across GxP functions. The role will report to the Senior Manager of GxP Quality Systems.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;\u0026amp;nbsp;\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Required location: Waltham, MA\u0026amp;nbsp;(hub-based, onsite 3-4 days per week)\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Track and support closure of Quality Events (e.g., Deviations, CAPAs, etc.)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support management of GxP training program, maintenance of GxP training curriculum/matrix, and facilitation and scheduling of GxP trainings\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Conduct Document Control reviews on controlled quality documents and ensure timely periodic reviews and implementation of document change requests\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support establishment, tracking, measurement, and reporting on metrics for the evaluation effectiveness of the Quality Management Systems\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support the management of the electronic document management system (Veeva QualityDocs), the electronic learning management system (Veeva Vault Training), and the electronic quality management system (Veeva QMS) as Business Administrator\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure the systems remain in a validated state, documenting changes via IT Change Controls, and executing scripts with evidence\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Evaluate opportunities for continuous improvements across the systems\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Work with stakeholders to ensure appropriate documentation of Service Provider selection, qualification, and evaluation/requalification\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support development of metrics related to Service Provider qualifications and Service Provider Quality Events\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Manage and track Audit Schedule ensuring adherence to Audit Program and timeliness of deliverables\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Required Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Minimum of 6+ years of experience in FDA regulated industry\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Previous hands-on experience with Veeva Quality Docs, Veeva Training, and Veeva QMS required\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A strong customer focus and ability to prioritize and adapt to business needs are required\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong business partner with all Functional Areas to ensure efficient collaboration and to drive results\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Self-motivated, detail oriented, well-organized, and able to demonstrate success with managing multiple projects simultaneously and other priorities\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to resolve day-to-day issues efficiently while maintaining compliance with applicable industry standards\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Clear, concise writing skills and good verbal communication and presentation skills\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\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 Life Sciences or a related field\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\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$122,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$150,000 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;For Full Time Roles:\u0026lt;/strong\u0026gt; This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;E-Verify:\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;color: rgb(255, 255, 255);\u0026quot;\u0026gt;\u0026amp;nbsp;#LI-Hybrid\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4036430008,"name":"Quality","child_ids":[],"parent_id":null}],"offices":[{"id":4018220008,"name":"Massachusetts","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kailera/jobs/5231065008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":4380144008,"location":{"name":"Waltham, Massachusetts"},"metadata":null,"id":5231065008,"updated_at":"2026-06-16T13:31:05-04:00","requisition_id":"283","title":"Manager, Pharmacovigilance Scientist","company_name":"Kailera Therapeutics, Inc.","first_published":"2026-05-26T12:18:32-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. \u0026lt;br\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What You will Do:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Manager, Pharmacovigilance Scientist will provide support to signal management, benefit-risk assessment, and other safety surveillance activities globally for assigned Kailera products throughout their lifecycle with focus on patients’ well-being and compliance with applicable regulatory requirements. Collaborate cross-functionally to ensure timely and accurate safety data retrieval, presentation, analysis, and reporting.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Required location: Waltham, MA\u0026amp;nbsp;(hub-based, onsite 3-4 days per week)\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Perform and coordinate complex benefit-risk assessment and safety surveillance activities. Perform safety signal management activities; conduct signal detection, author signal validation/evaluation reports, track and communicate findings\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Serve as a contributor to the safety governance framework, prepare safety data for review at Medical Safety Board meetings\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide pharmacovigilance input into core safety documents including Reference Safety Information (RSI) updates\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Contribute to medical literature monitoring activities and review of relevant publications for potential safety signals\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support and collaborate with safety physicians on safety review strategies\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Contribute to the management of aggregate safety reports (e.g., DSURs, PBRERs, PADERs, periodic line listings) including scheduling, planning, and authoring assigned sections\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaborate with cross-functional teams to regularly review emerging safety data for the purposes of trend analysis and/or signal detection as applicable\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Contribute to the preparation of queries in the safety database, retrieve and present data for regular and ad-hoc safety reviews\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaborate cross functionally to access and utilize data visualization and analysis tools for regular and ad-hoc safety reviews\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Contribute to the preparation of Risk Management Plans (RMPs)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Author responses to health authority requests in collaboration with safety physicians\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support safety physicians on authoring the safety sections of clinical trial documents (e.g., IB, Protocols, ICFs, CSRs) as needed. Provide safety surveillance expertise throughout the study lifecycle\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support safety physicians on the preparation of the safety sections of regulatory submission modules\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support audits/inspections and contribute to safety responses as needed\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Contribute to responses to deviations and CAPAs as related to pharmacovigilance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support the preparation and implementation of pharmacovigilance procedural documents\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Contribute as needed to the Global PSPV Business Continuity Plan\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide content for pharmacovigilance training as needed\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Contribute to the implementation of innovative technical or procedural solutions to improve PSPV safety surveillance capabilities\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Other responsibilities as assigned\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Required Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;A minimum of 6+ years of experience in global pharmacovigilance in pharmaceutical, biotech, or CRO setting\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience in safety data analysis, signal management, and benefit-risk evaluation\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Knowledge of safety databases (Argus, ArisG/LifeSphere Safety, Veeva or similar), ICSR workflows, and MedDRA coding\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with authoring or contributing to aggregate safety reports, signal assessment reports\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Working knowledge of relevant local and global regulatory requirements and guidance documents\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience in creating or managing SOPs or Work Instructions\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to proactively identify signals, trends, risks, and initiate/manage risk minimization activities\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to work independently and collaboratively with internal and external partners in a demanding environment\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to prioritize, multitask, and deliver quality results that meet tight timelines\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Fluency in written and spoken English with strong ability to communicate complex issues clearly\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Preferred Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Prior experience with contributing to clinical study or regulatory submission documents\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Knowledge of drug/biologics development process\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience in a startup or small biotech environment\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with obesity, metabolic, or cardiometabolic therapeutic areas\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Familiarity with AI/ML applications in pharmacovigilance signal detection\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with health authority pharmacovigilance inspections\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with EMA and FDA pharmacovigilance regulatory frameworks\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Advanced degree strongly preferred\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;Education:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Bachelors degree in life sciences\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Advanced degree (PharmD, MS, NP, RN) or equivalent in pharmacy, nursing, health care or other related life sciences field is preferred.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\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\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$127,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$155,000 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;For Full Time Roles:\u0026lt;/strong\u0026gt; This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;E-Verify:\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;color: rgb(255, 255, 255);\u0026quot;\u0026gt;\u0026amp;nbsp;#LI-Hybrid\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4036422008,"name":"Pharmaco and Safety","child_ids":[],"parent_id":null}],"offices":[{"id":4018220008,"name":"Massachusetts","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kailera/jobs/5231058008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":4380066008,"location":{"name":"Waltham, Massachusetts"},"metadata":null,"id":5231058008,"updated_at":"2026-06-16T13:31:05-04:00","requisition_id":"261","title":"Medical Director, Clinical Development","company_name":"Kailera Therapeutics, Inc.","first_published":"2026-05-26T12:18:36-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. \u0026lt;br\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What You’ll Do:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;We are seeking an experienced, highly motivated Medical Director, Clinical Development to join our growing team. This individual will play a pivotal role in designing and executing clinical development programs that advance our pipeline of innovative therapeutics. The successful candidate will bring strong clinical insight, a deep understanding of drug development in a biotech setting, and a proven ability to work cross-functionally in a dynamic, fast-paced environment.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Required location: Waltham, MA (hub-based, onsite 3-4 days per week)\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Responsible for medical monitoring/reporting and safety activities\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide medical leadership in the design, planning, and execution of clinical development strategies across multiple studies\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Acts as the medical contact at the company for clinical/medical issues\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Interprets, reports, and prepares oral and written results of product research, in concert with senior clinical personnel\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Serve as the medical expert for assigned assets studies\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Contribute to regulatory interactions and strategy, including IND/CTA submissions and briefing packages\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaborate and work closely with Clinical Operations to ensure appropriate site selection, patient recruitment strategies, and high-quality trial execution\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Oversee and support data interpretation, analysis, and clinical study reports\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Work closely with internal stakeholders, including Regulatory, Safety, CMC, Medical Affairs, and Translational Science teams\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Partner with external collaborators, KOLs, CROs, and investigators\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support scientific publications, conference presentations, and other external communications\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Participate in safety review meetings and provide clinical input into adverse event evaluation and reporting\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Required Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;3+ years of industry experience in clinical development, preferably in a biotech or small pharma environment\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Hands-on experience designing and executing clinical trials\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Understanding of GCP, clinical trial design, regulatory requirements, and safety monitoring\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent written and verbal communication skills, including protocol and regulatory document writing\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated ability to engage with KOLs, investigators, and cross-functional teams\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Can work independently, self-starter attitude\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Advanced PowerPoint skills; working knowledge of Excel and other commonly used\u0026amp;nbsp;clinical systems/tools\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to manage multiple studies and deadlines in a fast-paced environment\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Must be exceptionally detail oriented\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\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 in cardiometabolic therapeutic area is advantageous\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proven track record of contributing to IND submissions and global regulatory filings is a strong plus\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\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;MD or equivalent is required\u0026lt;/li\u0026gt;\n\u0026lt;/ul\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\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$242,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$290,000 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;For Full Time Roles:\u0026lt;/strong\u0026gt; This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;E-Verify:\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;color: rgb(255, 255, 255);\u0026quot;\u0026gt;\u0026amp;nbsp;#LI-Hybrid\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4036419008,"name":"Clinical Development","child_ids":[],"parent_id":null}],"offices":[{"id":4018220008,"name":"Massachusetts","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kailera/jobs/5231057008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":4380143008,"location":{"name":"Waltham, Massachusetts"},"metadata":null,"id":5231057008,"updated_at":"2026-06-16T13:31:05-04:00","requisition_id":"282","title":"Medical Director, Pharmacovigilance","company_name":"Kailera Therapeutics, Inc.","first_published":"2026-05-26T12:18:40-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. \u0026lt;br\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What You’ll Do:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Reporting to the Senior Medical Director, Global Patient Safety and Pharmacovigilance (DSPV), the Medical Director will provide strategic, scientific, and tactical leadership for global medical safety evaluation and benefit-risk management for assigned Kailera products throughout their lifecycle with focus on patient well-being and compliance with applicable regulatory requirements.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This role is instrumental in ensuring patient safety, regulatory compliance, and robust characterization of benefit-risk in both clinical development and real-world use, including shaping risk-management strategies, integrated evidence generation planning, and real-world evidence approaches.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The medical director will collaborate extensively across and within their own function to advance Kailera’s pharmacovigilance strategy to support the company’s evolving pipeline, innovation, and mission.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;\u0026amp;nbsp;\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Required location: Waltham, MA\u0026amp;nbsp;(hub-based, onsite 3-4 days per week)\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;\u0026amp;nbsp;\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Provide expert medical interpretation of safety data from all sources (clinical, post-marketing, literature, and RWE) and perform medical review of Individual Case Safety Reports (ICSR) within the ARGUS database\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Oversee and execute safety signal detection and evaluation activities, ensuring timely, scientifically sound assessments and the optimization of signaling systems through data visualization and analysis tools\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Incorporate insights from real-world data (EHRs, claims, registries) into surveillance and benefit-risk assessments to support evidence-generation strategies\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lead the development and oversight of global benefit-risk assessments and safety surveillance for clinical development programs and post-marketing phases\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Drive the lifecycle management of Risk Management Plans (RMPs) and other risk minimization strategies, ensuring proactive identification and mitigation of safety risks\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lead the authoring and medical review of safety sections for regulatory documents (IBs, Protocols, DSURs, PSUR/PBRERs, and RMPs) and safety modules for marketing applications\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support labeling decisions and contribute medical expertise to safety communications, risk materials, and scientific publications\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaborate with cross-functional stakeholders to integrate safety considerations into clinical development, post-marketing activities, and evidence-generation strategies\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lead and inspire a team of PSPV MDs, scientists, and operational colleagues, fostering a culture of accountability, scientific excellence, and collaboration\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Partner with senior leadership (SVP/Medical Director) on departmental goals, organizational design, budgeting, and long-term pharmacovigilance planning\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Act as a Subject Matter Expert (SME) for safety technology strategies, identifying innovative technical or resourcing solutions to improve DSPV surveillance capabilities\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Contribute to the design, implementation, and enhancement of drug safety processes and systems to ensure high-performance PV operations\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Maintain the medical safety governance framework, ensuring the timely identification, assessment, and escalation of significant safety issues\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Represent the PSPV function during audits and inspections, leading the preparation of responses and managing deviations or CAPAs related to medical safety science.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Drive the development of SOPs, work instructions, and \u0026quot;fit-to-purpose\u0026quot; pharmacovigilance training for internal and external partners\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Required Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;8+ years of experience in global pharmacovigilance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;2+ years of experience in clinical practice or academic medicine\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proven experience in safety data analysis, signal management, and benefit-risk evaluation\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Working knowledge of safety databases (Argus, ArisG/LifeSphere Safety, or similar)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated ability to develop and implement drug safety strategies, risk management plans, and safety governance models\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proven experience with authoring or contributing to clinical study and regulatory submission documents\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Thorough knowledge of relevant FDA and International Conference on Harmonization (ICH) guidelines, including Good Clinical Practices (GCP) guidelines\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong knowledge of global safety and pharmacovigilance regulations, guidelines, and industry standards (FDA, EMA, ICH, GVP)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience in creating or managing working documents such as SOPs or Work Instructions\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong ability to proactively identify risks and initiate/manage risk minimization activities\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong ability to lead in a cross functional setting and work collaboratively with internal and external partners in a fast-paced environment\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong ability to prioritize, multitask, and deliver quality results that meet tight timelines\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to influence and keep teams focused and motivated\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong ability to communicate complex issues clearly\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\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 in pharmacoepidemiology, data science, or medical affairs is a plus\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;Education:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;MD, DO or equivalent medical degree required. Ph.D. degree is a plus\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\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$254,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$305,000 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;For Full Time Roles:\u0026lt;/strong\u0026gt; This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;E-Verify:\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;color: rgb(255, 255, 255);\u0026quot;\u0026gt;\u0026amp;nbsp;#LI-Hybrid\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4036422008,"name":"Pharmaco and Safety","child_ids":[],"parent_id":null}],"offices":[{"id":4018220008,"name":"Massachusetts","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kailera/jobs/5231056008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":4380139008,"location":{"name":"Waltham, Massachusetts"},"metadata":null,"id":5231056008,"updated_at":"2026-06-16T13:31:05-04:00","requisition_id":"280","title":"Scientist II, Toxicology","company_name":"Kailera Therapeutics, Inc.","first_published":"2026-05-26T12:18:44-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. \u0026lt;br\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What You’ll Do:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The primary responsibility for the Scientist II, Toxicology will be to function as a key pharmacology and toxicology liaison/subject matter expert in support of external contract research organization (CRO) activities. The Scientist II, Toxicology is expected to ensure non-clinical studies are conducted in accordance with protocols and are aligned with the overall development strategy. In addition, the successful candidate will actively participate in scientific discussions within the non-clinical group for all compounds across the portfolio.\u0026lt;br\u0026gt;\u0026lt;br\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Required location: Waltham, MA\u0026amp;nbsp;(hub-based, onsite 3-4 days per week)\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;br\u0026gt;\u0026lt;strong\u0026gt;Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Serve as the primary Kailera representative (Study Monitor) for non-clinical (pharmacology and toxicology) studies conducted at CROs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaborate with Non-clinical Project Leaders and other scientists to design and develop study protocols, ensuring CROs have the technical capabilities to meet study requirements\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Conduct site visits to CROs to assess technical capabilities and ensure studies are executed in strict accordance with protocols\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Act as the first line of contact for study-related issues, assessing their impact on study integrity and escalating as needed\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure GLP compliance, adherence to Good Laboratory Practices, and alignment with company Standard Operating Procedures (SOPs)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Maintain study timelines and ensure non-clinical studies are conducted in accordance with overall program objectives\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Communicate study findings to non-clinical leadership and program teams in a timely and comprehensive manner\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Review and edit study protocols and reports to ensure scientific rigor, regulatory compliance (GLP, animal welfare, and safety), and high-quality study interpretation\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Serve as the point of contact for the receipt, review, and dissemination of study data across the department\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaborate with Non-clinical Project Leaders to interpret and analyze pharmacology and toxicology data, supporting risk assessment and decision-making\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Coordinate and oversee internal study data reviews to ensure alignment with project timelines\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Consolidate and communicate internal feedback on study reports to CROs, ensuring clarity and consistency\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Assist Non-clinical Project Leaders in integrating and assembling toxicology data for regulatory submissions (e.g., IND, NDA, BLA)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lead and contribute to cross-functional initiatives within the non-clinical department and across other teams to advance Kailera’s research objectives\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Actively participate in scientific discussions to assess toxicology findings and implications for drug development\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide mentorship and guidance to junior scientists, fostering a culture of scientific excellence and collaboration\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Take on additional responsibilities as assigned by non-clinical leadership\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026lt;br\u0026gt;Required Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Hands-on experience in animal husbandry and in vivo study conduct within a pharmacology or toxicology setting\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong understanding of scientific principles and study design in toxicology research\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Knowledge of regulatory policies and procedures related to GLP study design, execution, and reporting\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Familiarity with current trends in non-clinical safety assessment and the CRO landscape\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent written and verbal communication skills, with the ability to author clear, concise, and accurate documents for global regulatory submissions and health authority interactions\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Solid understanding of ICH, FDA, and EMA guidelines related to the nonclinical assessment of drug candidates\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\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 in Biology, Animal Sciences, Toxicology, or a related field with 2-5 years of relevant experience OR Master’s degree with 8+ years of experience OR Bachelor’s degree with 10+ years of relevant experience\u0026lt;/li\u0026gt;\n\u0026lt;/ul\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\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$127,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$155,000 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;For Full Time Roles:\u0026lt;/strong\u0026gt; This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;E-Verify:\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;color: rgb(255, 255, 255);\u0026quot;\u0026gt;\u0026amp;nbsp;#LI-Hybrid\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4036418008,"name":"Non-Clinical","child_ids":[],"parent_id":null}],"offices":[{"id":4018220008,"name":"Massachusetts","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kailera/jobs/5231054008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":4380160008,"location":{"name":"Waltham, Massachusetts"},"metadata":null,"id":5231054008,"updated_at":"2026-06-16T13:31:05-04:00","requisition_id":"288","title":"Senior Director, Quality Systems","company_name":"Kailera Therapeutics, Inc.","first_published":"2026-05-26T12:18:52-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. \u0026lt;br\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What You’ll Do:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Senior Director, Quality Systems is a high-impact leadership role responsible for the architecture, implementation, and continuous improvement of our Enterprise Quality Management System (eQMS). You will report to the Vice President, Quality and will serve as the primary architect of our quality framework, ensuring our global operations remain compliant with GxP standards while maintaining the agility required of a growing biotech.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Required location: Waltham, MA\u0026amp;nbsp;(hub-based, onsite 3-4 days per week)\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Define and execute the long-term vision for the Quality Management System (QMS) to support global clinical development and future commercialization\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide Quality oversight for GxP systems change controls. Support validation planning, execution, approvals\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Act as the Business Owner for Veeva QualityVault. Lead the optimization of modules including Document Control, Training, Deviations, CAPA, and Change Control\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Establish and lead Quality Management Reviews (QMR). Develop and report on Key Quality Indicators (KQIs) and metrics to senior leadership to drive proactive risk management\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure the QMS meets global regulatory requirements (FDA 21 CFR Parts 11, 210, 211, and 820; ICH E6; EudraLex Volume 4)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lead the QMS strategy for inspection readiness. Serve as a key interface during regulatory inspections (FDA, EMA, etc.) and oversee the internal and vendor audit programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Champion a culture of Quality. Streamline complex workflows to reduce cycle times for document approvals and deviation closures without compromising compliance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Build and mentor a high-performing team of Quality professionals, fostering a collaborative environment that balances technical rigor with pragmatic problem-solving\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;Required Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;12+ years of experience in Quality Assurance within the Biotech/Pharmaceutical industry, with at least 5 years in a senior leadership capacity\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Direct experience implementing or managing Veeva QualityVault is mandatory. You should be proficient in configuring workflows and leveraging the platform for data-driven decision-making\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proven track record in mid-sized companies navigating the transition from early-phase clinical trials to late-stage pivotal studies\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Deep knowledge of global GxP regulations and experience participating in (or leading) successful regulatory inspections\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Exceptional ability to translate complex quality requirements into actionable business strategies for non-quality stakeholders\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;Education:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Bachelor’s degree required, scientific or engineering discipline preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Advanced degree preferred\u0026lt;/li\u0026gt;\n\u0026lt;/ul\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\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$229,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$280,000 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;For Full Time Roles:\u0026lt;/strong\u0026gt; This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;E-Verify:\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;color: rgb(255, 255, 255);\u0026quot;\u0026gt;\u0026amp;nbsp;#LI-Hybrid\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4036430008,"name":"Quality","child_ids":[],"parent_id":null}],"offices":[{"id":4018220008,"name":"Massachusetts","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kailera/jobs/5231046008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":4380140008,"location":{"name":"Waltham, Massachusetts"},"metadata":null,"id":5231046008,"updated_at":"2026-06-16T13:31:05-04:00","requisition_id":"281","title":"Senior Scientist, Drug Product Manufacturing and Development","company_name":"Kailera Therapeutics, Inc.","first_published":"2026-05-26T12:19:04-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. \u0026lt;br\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What You’ll Do:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This Senior Scientist will support ongoing activities for drug product formulation and manufacturing with external partners and CDMOs. This would include manufacturing process development and optimization, clinical supply manufacture, and commercial preparedness with a focus on oral solid dosage forms. The individual will have a working knowledge of drug product development through all stages of clinical development.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Required location: Waltham, MA\u0026amp;nbsp;(hub-based, onsite 3-4 days per week)\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Support technology transfer, formulation, and process development, optimization, scale-up, and manufacturing of clinical supplies, acting as Kailera’s person-in-plant for activities critical to program success\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaborate closely with internal cross-functional teams, including Drug Substance, Analytical Development, Supply Chain, Clinical, Quality Assurance, and Regulatory Affairs to ensure seamless progression of projects\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Review master batch records and executed batch records to ensure product quality\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Author change controls, review specifications, change notifications, and manage manufacturing deviations as necessary, working closely with Kailera’s quality group\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Present formulation development and manufacturing updates to internal and external stakeholders periodically\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Author, review, and update CMC specific documents to support worldwide regulatory submissions (i.e., IND, IMPD, and NDA)\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Required Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;5+ years of experience in solid-oral dosage form development. Technical expertise in unit operations common to solid oral dosage form (e.g., milling, wet/dry granulation, compression, and film-coating)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Extensive experience with management of day-to-day activities at CDMO’s\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong troubleshooting skills with the ability to quickly provide input in a fast-paced environment\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong working knowledge of Microsoft suites and common scientific software\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with design of experiment (JMP/Minitab)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience using quality systems such as Veeva to author and approve documents\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent verbal, written, and interpersonal skills\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to travel up to 10-20% (domestic and international)\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\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 in the GLP-1 space, late-stage development\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;Education:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;B.S. and 12+ years of experience, advanced degree with 10+ years, or a PhD with 5-8 years of experience\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Degree in Engineering, Pharmaceutical Sciences, Chemistry or closely related field\u0026lt;/li\u0026gt;\n\u0026lt;/ul\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\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$143,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$175,000 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;For Full Time Roles:\u0026lt;/strong\u0026gt; This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;E-Verify:\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;color: rgb(255, 255, 255);\u0026quot;\u0026gt;\u0026amp;nbsp;#LI-Hybrid\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4036426008,"name":"Drug Product","child_ids":[],"parent_id":null}],"offices":[{"id":4018220008,"name":"Massachusetts","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kailera/jobs/5231045008","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":4380080008,"location":{"name":"Waltham, Massachusetts"},"metadata":null,"id":5231045008,"updated_at":"2026-06-16T13:31:05-04:00","requisition_id":"266","title":"Senior Specialist, GMP Quality Assurance ","company_name":"Kailera Therapeutics, Inc.","first_published":"2026-05-26T12:19:09-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. \u0026lt;br\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;What You’ll Do:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Senior Specialist, GMP Quality Assurance will collaborate internally with QA, RA, and CMC departments. As needed, work with external Approved Service Providers to ensure oversight and compliance. The Senior Specialist will perform review of drug substance/drug product manufacturing records and associated documents (i.e. deviations) for product that will be released for use in Kailera phase I-III clinical programs. The Senior Specialist will help continuously improve Quality System Procedures related to GMP activities related to their function and will collaborate closely with internal cross-functional teams.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Required location: Waltham, MA\u0026amp;nbsp;(hub-based, onsite 3-4 days per week)\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Review and approve Service Provider GMP documentation\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Review and approve master batch/packaging records\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Review executed batch/packaging records for Intermediates, Drug Substance, and Drug Product\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Prepare batch file for final batch disposition for Kailera’s Phase I-III clinical programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Review GMP Quality Events, change controls, CAPA’s, and other GMP documentation as needed\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Identify and escalate issues effectively\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Compile data for Quality System Reviews\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Evaluate GMP activities for continuous improvement opportunities\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support creation and continuous improvement of Kailera procedures\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Other Quality Assurance responsibilities as assigned\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Required Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;6+ years of experience in an FDA regulated Pharmaceutical Industry with GMP experience\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Understanding and knowledge of industry standards, concepts, current cGMP (21 CFR Parts 210 \u0026amp;amp; 211 \u0026amp;amp; Part 11 and EudraLex), and other agency standards and guidance as they relate to quality systems/quality assurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with review of GMP manufacturing/packing records (Master/Executed Batch Records, Deviations, Change Controls, etc.) associated with Phase I-III clinical studies\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proficient in Veeva QualityDocs and Veeva QMS a plus\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrates proven track record of communication with internal and external Service providers\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to identify quality issues requiring escalation\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Clear, concise writing skills and good verbal presentation skills\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Self-motivated, detail oriented, well organized, and able to manage multiple projects\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to interact constructively and efficiently with co-workers within and across departments and Management, as well as with Service providers in a professional and collaborative manner\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Preferred Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Biotech experience preferred\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\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;BA or BS degree in a scientific discipline or supplemental Quality education\u0026lt;/li\u0026gt;\n\u0026lt;/ul\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\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$122,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$150,000 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;For Full Time Roles:\u0026lt;/strong\u0026gt; This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;E-Verify:\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;color: rgb(255, 255, 255);\u0026quot;\u0026gt;\u0026amp;nbsp;#LI-Hybrid\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4036430008,"name":"Quality","child_ids":[],"parent_id":null}],"offices":[{"id":4018220008,"name":"Massachusetts","location":null,"child_ids":[],"parent_id":null}]}],"meta":{"total":19}}