Director Trial Master File Jobs (NOW HIRING)

Repertoire Immune Medicines is a clinical-stage biotechnology company harnessing the power of the human immune system to develop transformative therapies for cancer and autoimmune disease. Using its proprietary DECODE™ platform—which maps the immune synapse between T cell receptors (TCRs) and their antigen targets—Repertoire translates unique biological insights into potent and targeted off-the shelf immune medicines. The company integrates deep protein engineering expertise with artificial intelligence, powered by a proprietary DECODE database of over one billion TCR-antigen interactions, to accelerate discovery and optimize drug candidates.

From its sites in Cambridge, Massachusetts and Zurich, Switzerland, Repertoire is advancing a pipeline of T cell-targeted immunotherapies with the potential to address a broad range of cancers and autoimmune disorders. The company’s lead oncology program, RPTR-1-201, a TCR bispecific, has initiated a Phase 1/2 clinical trial across multiple solid tumor indications. Repertoire plans to advance additional TCR bispecific therapies into clinical trials over the next 12-18 months. In autoimmune disease, Repertoire is partnering with leading pharmaceutical companies to develop mRNA tolerizing therapies designed to selectively expand regulatory T cells and reset the immune system.

Repertoire was founded in 2019 by Flagship Pioneering and is supported by a strong investor base. The DECODE platform has been validated through four strategic partnerships with leading pharmaceutical companies—Bristol Myers Squibb, Genentech, Eli Lilly, and Pfizer—representing over $4.5 billion in disclosed total deal value and $185 million in upfront payments received to date.

We are seeking an experienced Clinical Trial Manager to provide both strategic leadership and hands‑on oversight of early‑stage oncology trials, including first‑in‑human trials. Reporting to the Director of Clinical Operations, you will oversee all aspects of trial management -from start-up through close‑out - ensuring trials are delivered on time, on budget, and fully compliant with regulatory and quality standards. As the primary point of contact for cross‑functional teams, CROs, vendors, and investigative sites, you will provide strategic guidance, operational oversight, and proactive risk management.

This is a hands‑on role in a fast‑paced, collaborative environment, offering the opportunity to directly influence the advancement of innovative therapies for patients.

• Work with a cross‑functional trial teams to manage all aspects of clinical trials ensuring trials are executed on time, on budget, and in compliance with SOPs, ICH/GCP, and regulatory requirements.
• Identify and anticipate trial issues or risks that may impact budget, resources, and timelines; plan mitigation strategies with the cross‑functional team and escalates as necessary.
• Manage outsourced activities with CROs and vendors (e.g., biomarker and specialty labs), including oversight of performance, compliance with ICH/GCP and SOPs, development of oversight plans, and review of monitoring reports to maintain trial quality and compliance.
• Manage trial budgets and contracts, including forecasting, invoice review, and expense tracking for accurate reporting.
• Monitor trial progress, including participant enrollment, clinical data review, sample collection, and adherence to timelines; provide regular trial status updates and metrics.
• Guide trial teams and investigator sites to ensure consistent interpretation and execution of trial protocols and procedures.
• Contribute to the development and review of trial‑related documents (protocols, ICFs, clinical trial plans, CRFs, manuals, reports, and regulatory documentation).
• Ensure Trial Master File (TMF) completeness, accuracy, and inspection readiness, whether managed internally or outsourced.
• Participate in the development and refinement of departmental SOPs, processes, and best practices.

• Bachelor’s degree in Life Sciences or related field (advanced degree preferred) with 3+ years of clinical trial management experience.
• Proven track record in CRO and vendor management, including oversight of performance, issue resolution, and budget management.
• Ability to lead trials independently, ideally within a small, fast‑paced team environment.
• Working knowledge of data management, biostatistics, and pharmacovigilance.
• Global trial experience, including management of multi‑country trials from start‑up through close‑out.
• Thorough understanding of FDA regulations and ICH GCP guidelines.
• Proficiency with clinical trial systems (EDC, CTMS, TMF) and expertise in trial master file organization and regulatory documentation.
• On‑site monitoring experience (preferred).
• Excellent communication skills, with the ability to collaborate effectively across teams.
• Highly organized with strong problem‑solving, critical thinking, and prioritization skills.
• Ability to travel domestically and internationally, up to 20%.

The base salary for this role ranges from $112,000 to $160,000 and is determined based on a candidate’s skills, experience, and internal equity. In addition to a competitive base salary, Repertoire offers a broad range of benefits designed to attract, retain, and motivate top talent, including medical, dental, vision, and life insurance, flexible time off, a 401(k) retirement plan, and short‑ and long‑term incentive opportunities. Compensation and benefits are based on Repertoire’s good faith estimate at the time of publication and may be updated in the future.

Repertoire is committed to social responsibility and to developing an inclusive culture. Much as the power of the immune system lies in the diversity of T and B cells, our work requires the creativity and ingenuity of a diverse workforce. We believe in actively pursuing equity in all facets of the work experience at Repertoire. We will continue to educate ourselves about the inequities and barriers present in our society and take action as a company where we can make a difference.

Repertoire is proud to be an Equal Opportunity Employer.