Clinical Trial Manager

Repertoire Immune Medicines

Repertoire Immune Medicines is a biotechnology company working to unlock and direct the remarkable power of the human immune system to treat cancer and autoimmune disease. The company was founded in 2019 on the belief that understanding the repertoire of T cell receptor (TCR)-antigen immune synapses that maintain health and drive disease represents one of the greatest opportunities for innovation in medical science.

Repertoire scientists created and developed the DECODE platform, which allows in-depth characterization of TCR‑antigen pairs and the ability to deploy this information in the form of novel targeted immune medicines to fundamentally reprogram the immune system to kill tumors or induce immune homeostasis.

From its sites in Cambridge, Massachusetts and Zurich, Switzerland, Repertoire’s team is advancing a pipeline of DECODE‑enabled immune medicines. For cancer, we are developing a pipeline of TCR bispecific molecules for treatment of multiple cancer types. Repertoire is progressing through IND‑enabling studies with its lead development candidate and is planning to initiate a Phase 1/2 clinical trial in multiple cancer indications.

In addition, we are developing a pipeline of mRNA tolerizing vaccines for treatment of autoimmune diseases.

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.

• Work with 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 escalating 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…