Clinical Trial Manager

Clinical Trial Manager

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 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 TM 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. Repertoire was founded in 2019 by Flagship Pioneering and is supported by a strong investor base. The company entered into a collaboration and license agreement with Genentech in April of 2025 to discover and develop innovative T cell-targeted immune medicines for an autoimmune indication. In addition, Repertoire entered a strategic partnership in April of 2024 with Bristol Myers Squibb to develop tolerizing vaccines for up to three 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. 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.

Key Responsibilities

• 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.

Qualifications/Experience

• 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. Recruitment & Staffing Agencies: Repertoire Immune Medicines ("Repertoire") does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Repertoire or its employees is strictly prohibited unless contacted directly by Repertoire's internal Human Resources team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Repertoire, and Repertoire will not owe any referral or other fees with respect thereto.