{"jobs":[{"absolute_url":"https://job-boards.greenhouse.io/tr1x/jobs/4681051006","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":4547523006,"location":{"name":"San Diego, CA"},"metadata":null,"id":4681051006,"updated_at":"2026-05-13T11:43:48-04:00","requisition_id":"57","title":"Director, Clinical Operations","company_name":"Tr1X","first_published":"2026-05-13T11:43:48-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;About Tr1X\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Tr1X is a clinical-stage biotechnology company developing engineered Tr1 cell therapies to restore immune balance in autoimmune and inflammatory diseases. Leveraging the unique biology of Tr1 cells, the company is advancing a pipeline of off-the-shelf allogeneic and in vivo CAR-Tr1 therapies designed to deliver targeted immunoregulation and address diseases driven by immune dysfunction, including transplant-related complications. Founded by pioneers in the discovery of Tr1 cells, Tr1X, Inc. is focused on developing durable, potentially curative therapies for conditions with high unmet need. For more information, visit www.tr1x.bio.\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Position Summary\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;The Director, Clinical Operations provides strategic leadership and operational oversight for the implementation and execution of clinical trials from study start-up through close-out. The Director is accountable for leading cross-functional clinical study teams; directing contract research organizations (CROs), study vendors, and investigative sites; and ensuring all clinical trial activities are executed in alignment with corporate objectives, timelines, budgets, regulatory requirements, GCP guidelines, and internal SOPs. This role serves as a key operational leader within the organization and is responsible for mentoring, developing, and supervising clinical operations personnel.\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Key Responsibilities\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Provide strategic leadership as the Clinical Study Lead for cross-functional teams to ensure study start-up, enrollment, maintenance, and close-out activities are executed on schedule, within budget, and in accordance with quality expectations.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Direct and oversee all aspects of clinical study management to ensure operational excellence, inspection readiness, and delivery of high-quality clinical data.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Lead the clinical operational development, review, and finalization of clinical trial protocol synopses, protocols, protocol amendments, and other key study-related documents.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Lead the CRO and vendor selection strategy for outsourced activities, including RFP development, bid management, proposal evaluation, budget negotiations, and executive-level vendor selection decisions.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Direct negotiation, execution, and oversight of contracts and scopes of work with CROs, study vendors, consultants, and investigative sites.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Oversee the development and maintenance of critical study documents, including informed consent templates, management plans, study trackers, and operational plans, ensuring appropriate delegation and accountability.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Chair and lead internal and external clinical study meetings, governance reviews, and cross-functional operational discussions, ensuring alignment of objectives, decisions, and action items.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Partner strategically with Regulatory Affairs to ensure timely preparation and submission of site essential regulatory documentation to the FDA and other regulatory authorities.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Develop and oversee clinical monitoring strategies and monitoring plans to ensure compliance, quality oversight, and operational consistency across studies and vendors.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Provide strategic oversight for case report form (CRF) design, edit check development, and data collection methodologies in partnership with Data Management and Clinical Development.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Lead site initiation planning and execution activities, including oversight of training materials, presentations, and investigator engagement strategies.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Provide leadership and governance oversight of CROs, field monitors, and clinical vendors to ensure contractual obligations, quality metrics, and operational deliverables are achieved.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Establish oversight processes for monitoring visit reports, protocol deviations, CAPAs, and action item resolution to ensure quality and compliance standards are maintained.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Direct and oversee study-wide operational activities including vendor management, biospecimen handling, investigational product logistics, investigator payments, data quality oversight, and centralized records management.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Lead the review and analysis of clinical data reports to identify operational, safety, and efficacy trends and communicate findings to cross-functional leadership and governance committees.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Ensure Trial Master File (TMF) oversight and inspection readiness throughout the duration of all assigned studies.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Lead and facilitate internal clinical program meetings, investigator meetings, safety review committees, and other cross-functional governance forums.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Partner with departmental leadership to define and execute clinical development operational strategies, resource planning, and process optimization initiatives.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Proactively identify operational risks and implement mitigation strategies to ensure study continuity, compliance, and successful execution.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Travel to clinical sites, investigator meetings, and vendor locations as required, up to 15%.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Foster a culture of accountability, collaboration, operational excellence, and continuous improvement within a fast-paced, dynamic clinical development environment.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Perform additional strategic and operational responsibilities as required to support evolving business and clinical development objectives.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong style=\u0026quot;font-size: 10pt;\u0026quot;\u0026gt;Required Qualifications \u0026amp;amp; Experience\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Bachelor’s degree in a scientific or healthcare-related discipline with a minimum of 10 years of progressive clinical operations experience, including at least 5 years of direct sponsor clinical study management and leadership experience.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Demonstrated leadership experience managing complex global or multi-center clinical trials across multiple phases of development.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Experience in cell and/or gene therapy clinical trials preferred, particularly within Multiple Sclerosis, Inflammatory Bowel Disease, or other autoimmune indications.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Extensive working knowledge of ICH/GCP guidelines, FDA regulations, and global clinical trial regulatory requirements.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Proven ability to lead cross-functional teams, influence stakeholders, and drive strategic clinical operations initiatives in a fast-paced environment.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Strong operational leadership skills with demonstrated expertise in study start-up, trial execution, vendor oversight, risk management, and inspection readiness.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Experience supporting pre-NDA programs and Phase 1 first-in-human clinical trials, including operational strategy, study oversight, monitoring, and close-out activities.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Advanced experience with clinical trial systems including eTMF, CTMS, EDC, safety databases, and other clinical technologies.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Exceptional strategic thinking, problem-solving, organizational, communication, and executive presentation skills.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Ability to independently manage competing priorities while leading within a matrixed cross-functional organizational structure.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Demonstrated success mentoring and developing high-performing clinical operations teams.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;High level of professionalism, integrity, accountability, and business acumen.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Other Requirements\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Legally authorized to work for any employer in the U.S.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Travel is required up to 15%.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;The position is based on-site in San Diego, CA.\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;em\u0026gt;The job responsibilities and requirements provided above are intended to describe the general nature of the work performed by individuals assigned to this job classification. It is not intended to be an exhaustive list of all duties and requirements. Tr1X retains the right to add, change, or delete duties, education, experience or any other requirements of the position at any time.\u0026lt;/em\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Working at Tr1X\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;At Tr1X, our team is united by a singular shared mission: to transform patients’ lives through breakthrough science. We are a group of skilled experts driven by urgency, innovation and a collaborative spirit. Our culture thrives on excellence, positivity, persistence and the agility to tackle new challenges head-on. With an unwavering commitment to patients, science and one another, we foster an environment where team members feel engaged, supported and empowered to make a meaningful impact. We envision a world where autoimmune diseases are not just being treated but are cured.\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Base Pay Range Anticipated: $206,000 - $225,000\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Tr1X considers a variety of factors to determine salary such as education, years of experience, time in the position level, training, knowledge, skills, geographic location, and the market value of the position.\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Compensation and Benefits\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;Tr1X provides a fair and competitive total rewards program that includes base salary; discretionary annual target bonus; incentive stock options; 401(k) retirement plan with company contribution; health and welfare insurance plans for employees (and their families) that include medical, dental, vision, long-term and short-term disability, and life insurance; paid time off (PTO); and paid holidays.\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;em\u0026gt;Tr1X embraces a diverse, open, and inclusive environment and believes a strong culture connection is key to success. Tr1X is committed to fairness in recruitment, hiring, transfer, promotion or any other employment practice without regard to race, color, citizenship, national origin, ancestry, religion, sex, pregnancy, marital status, sexual orientation, gender, gender identity and expression, age, physical and medical disability, medical condition, genetic information, political affiliation, protected veteran status, or any other characteristic protected by law. If you are an individual needing assistance to complete an employment application or would like to request an accommodation, please contact the Human Resources department at careers@tr1x.bio.\u0026lt;/em\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Notice to Employment Agencies\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;\u0026quot;\u0026gt;The Tr1X talent acquisition program is managed through internal resources, and unsolicited referrals and resumes are not accepted from employment agencies, unless advance written authorization is granted from the human resources department. Tr1X shall not be liable for any fees arising from any unsolicited or unauthorized candidate information received relative to position vacancies.\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4009011006,"name":"Clinical Development","child_ids":[],"parent_id":null}],"offices":[{"id":4012596006,"name":"San Diego, CA Corporate Headquarters","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/tr1x/jobs/4665258006","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":4539742006,"location":{"name":"San Diego, CA"},"metadata":null,"id":4665258006,"updated_at":"2026-04-21T21:27:56-04:00","requisition_id":"56","title":"Senior Scientist, LNP Platform \u0026 Process Development","company_name":"Tr1X","first_published":"2026-03-24T14:08:06-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Tr1X\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Tr1X is a private, clinical-stage biotechnology company focused on developing a novel class of regulatory T cell-based products to cure autoimmune and inflammatory diseases. Founded by industry experts, including the scientists who discovered Type 1 regulatory T (Tr1) cells, the company is developing a pipeline of off-the-shelf allogeneic cell therapies for autoimmune diseases with high unmet medical need. Our TRX cells are designed to mimic the function of naturally occurring Tr1 cells, which work to restore immune tolerance, stopping severe autoimmune and inflammatory disease in its tracks. Tr1X is the first company ever to use an allogeneic engineered Tr1 cell therapy in clinical trials. Tr1X is headquartered in San Diego, CA. For more information, please visit www.tr1x.bio.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Position Summary\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Senior Scientist, LNP Platform \u0026amp;amp; Process Development (Scientist) is an experienced hands-on, lab-based, individual contributor that leads the design, development, and optimization of lipid nanoparticle (LNP) formulation and process development efforts supporting the Tr1X in vivo CAR-Treg platform. This individual plays a central role in developing and advancing the targeted lipid nanoparticle (tLNP) delivery systems from early research optimization through scalable, IND-enabling development.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This is a high-impact, foundational role within the company. The Scientist helps design and implement the LNP backbone of the platform and influence both short-term program execution and long-term manufacturability strategy. The Scientist brings deep hands-on expertise in LNP formulation and process development, strong analytical rigor, and the ability to thrive in a fast-paced startup environment.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Key Responsibilities\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Contribute to the design, development, and optimization of LNP formulations for mRNA delivery, including targeted LNP systems incorporating conjugated or functionalized lipids.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Evaluate lipid composition, formulation parameters, and mixing conditions to optimize particle size, polydispersity, encapsulation efficiency, stability, release characteristics, and biological performance.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Develop scalable, GMP-compatible manufacturing processes to support program advancement.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Apply Quality by Design (QbD) principles and Design of Experiment (DoE) studies to study design and execution.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lead the development and optimization of analytical characterization methods (both in-house and at the external CDMO), including but not limited to DLS, fluorescence-based assays such as Ribogreen, HPLC/UPLC methods (CAD, UV, IP-RP, SEC, IEX), LC-MS, and endotoxin testing.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Interpret analytical and stability data to establish meaningful correlations between physicochemical properties and biological function.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaborate closely with platform biology teams to support in vitro and in vivo studies, prepare development reports and technical documentation, and contribute to technology transfer activities with external CDMO partners.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Spearhead IND-enabling documentation and contribute to defining the long-term strategy for scalable LNP platform development.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Perform other responsibilities as required based on business needs.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Required Qualifications \u0026amp;amp; Experience\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Ph.D. in Chemical Engineering, Bioengineering, Pharmaceutical Sciences, Chemistry, or a related field with a minimum 4 years of relevant industry experience; or M.S. with 8+ years; or B.S. with 10+ years.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated in-depth expertise in LNP formulation and process development, including hands-on experience with microfluidic or scalable mixing technologies and downstream purification strategies such as TFF.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong experience with analytical characterization of LNP systems and application of statistical design tools for process optimization.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Highly organized, scientifically rigorous, and capable of independently driving projects while collaborating effectively in a multidisciplinary startup environment.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with mRNA therapeutics or nucleic acid delivery systems.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Prior exposure to immunotherapy or cell therapy platforms preferred.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Familiarity with regulatory expectations for CMC development and experience supporting technology transfer to external manufacturing partners preferred.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience correlating formulation attributes with in vivo performance highly desirable.\u0026lt;br\u0026gt;Ability to actively serve, collaborate, and develop relationships inside and outside the organization.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent written and oral communication skills.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong analytical and problem-solving skills; great attention to detail and the ability to drive timely and fact-based decision making.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to function in a rapidly changing environment and handle multiple priorities.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated ability to partner, build trust, and cultivate positive working relationships with CDMOs.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with mRNA production and analytical quality control preferred.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Effectively communicate changes and resolve issues with CDMOs.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lead and/or participate in cross functional development and manufacturing projects to ensure company objectives are met and exceeded.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to don and wear appropriate clean room attire and wear all required Personal Protective Equipment.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Other Requirements\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Legally authorized to work for any employer in the U.S.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Position is on site in San Diego\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Travel may be required up to 10% of the time\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;The job responsibilities and requirements provided above are intended to describe the general nature of the work performed by individuals assigned to this job classification. It is not intended to be an exhaustive list of all duties and requirements. Tr1X retains the right to add, change, or delete duties, education, experience or any other requirements of the position at any time.\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Working at Tr1X\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;At Tr1X, our team is united by a singular shared mission: to transform patients’ lives through breakthrough science. We are a group of skilled experts driven by urgency, innovation and a collaborative spirit. Our culture thrives on excellence, positivity, persistence and the agility to tackle new challenges head-on. With an unwavering commitment to patients, science and one another, we foster an environment where team members feel engaged, supported and empowered to make a meaningful impact. We envision a world where autoimmune diseases are not just being treated but are cured.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Base Pay Range Anticipated: $145,000 - $160,000\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Tr1X considers a variety of factors to determine salary such as education, years of experience, time in the position level, training, knowledge, skills, geographic location, and the market value of the position.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Compensation and Benefits\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Tr1X provides a fair and competitive total rewards program that includes base salary; discretionary annual target bonus; incentive stock options; 401(k) retirement plan with company contribution; health and welfare insurance plans for employees (and their families) that include medical, dental, vision, long-term and short-term disability, and life insurance; paid time off (PTO); and paid holidays.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Tr1X embraces a diverse, open, and inclusive environment and believes a strong culture connection is key to success. Tr1X is committed to fairness in recruitment, hiring, transfer, promotion or any other employment practice without regard to race, color, citizenship, national origin, ancestry, religion, sex, pregnancy, marital status, sexual orientation, gender, gender identity and expression, age, physical and medical disability, medical condition, genetic information, political affiliation, protected veteran status, or any other characteristic protected by law. If you are an individual needing assistance to complete an employment application or would like to request an accommodation, please contact the Human Resources department at careers@tr1x.bio.\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Notice to Employment Agencies\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Tr1X talent acquisition program is managed through internal resources, and unsolicited referrals and resumes are not accepted from employment agencies, unless advance written authorization is granted from the human resources department. Tr1X shall not be liable for any fees arising from any unsolicited or unauthorized candidate information received relative to position vacancies.\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4009010006,"name":"Technical Operations","child_ids":[],"parent_id":null}],"offices":[{"id":4012596006,"name":"San Diego, CA Corporate Headquarters","location":null,"child_ids":[],"parent_id":null}]}],"meta":{"total":2}}