Senior Clinical Trial Manager

Location: United States (Bay Area)

Therapeutic Focus: Immune Tolerance | Regulatory T Cells | Autoimmune Diseases | Epigenetics

Employment Type: Full-time

About RegCell

RegCell, co-founded by 2025 Nobel Laureate Shimon Sakaguchi, is a biotechnology company advancing a differentiated immune tolerance platform with the potential to transform the treatment of autoimmune diseases.

After closing a Series A and securing $60M in non-dilutive capital, the company is moving quickly to launch multiple clinical trials and has prioritized hiring a Senior Clinical Trial Manager. This is a rare opportunity to join a company at its foundation and play a hands-on role in bringing our first programs into the clinic.

Position Summary

RegCell is seeking a Senior Clinical Trial Manager to manage the day-to-day execution of RC-101. Reporting to the Head of Clinical Operations, this person will keep the study moving from start-up through enrollment, conduct, and closeout.

This is an execution-focused role for someone who thrives on detail: drafting site manuals, tracking site activation, chasing contracts and budgets, following up on monitoring findings, and troubleshooting cell product shipments. You will be the primary day-to-day contact for the CRO, clinical sites, and study vendors, and will work closely with colleagues in CMC/manufacturing, quality, and regulatory. By owning the operational delivery of RC-101.

Because every person on a small team shapes how we work together, we place as much weight on how you collaborate as on what you deliver.

Key Responsibilities

Day-to-day study management

• Manage the day-to-day execution of RC-101, keeping the study on track against timelines, budget, and quality standards.
• Drive study start-up activities, including site feasibility and selection, site contracts and budgets, regulatory and ethics submission packages, essential document collection, and site activation.
• Maintain study trackers for site activation, enrollment, patient visits, and deliverables; identify issues early and bring them to the Head of Clinical Operations with proposed solutions.
• Work hands-on with sites to support patient screening and enrollment, and resolve site questions and issues quickly.
• Coordinate cell therapy logistics with CMC, quality, and supply chain, including chain of identity, product scheduling, shipment, and site readiness.
• Conduct in-house data review, drive query resolution, and support database lock and study closeout.

CRO, vendor, and site management

• Serve as the day-to-day sponsor contact for the CRO and study vendors (e.g., central and specialty labs, EDC/IRT, couriers); run regular operational meetings and track action items to closure.
• Review monitoring visit reports (SIV, IMV, COV), follow up on findings, and confirm issues are resolved; conduct sponsor visits as needed (up to approximately 20% travel).
• Review vendor and site invoices against contracts and track study spend.
• Train site staff on the protocol and study procedures, and build strong working relationships with investigators and study coordinators.

Study documents and compliance

• Prepare and maintain study plans, manuals, and site-facing materials (e.g., pharmacy and product handling manual, lab manual, ICF templates), and contribute to the protocol, CRFs, and CSR.
• Support user acceptance testing of EDC, IRT, and other study systems.
• Maintain an inspection-ready TMF and ensure study conduct complies with GCP, ICH, FDA, and applicable regulations.
• Use and refine study-level templates, trackers, and work instructions as needed.

Required Qualifications

• Minimum of 5 years of hands-on clinical trial management experience at a sponsor or CRO, including day-to-day management of at least one study through start-up and into enrollment.
• A track record of executing studies directly (site activation, vendor management, monitoring follow-up, TMF), not only overseeing the work of others.
• Experience with early-phase (Phase 1 or 1/2) studies.
• Thorough knowledge of GCP, ICH, FDA, and applicable global regulatory requirements, and of clinical trial medical terminology.
• Highly organized and detail-oriented, with the ability to manage many moving parts and shifting priorities.
• Clear, concise written and verbal communication skills.
• Proven ability to build productive relationships with investigators, site staff, CROs, vendors, and internal colleagues.
• Able and willing to travel domestically (approximately 20%).

Preferred

• Experience in cell therapy (e.g., Treg, CAR-T, CAR-NK, or other engineered or autologous/allogeneic cell products), including cell product logistics and chain of identity management.
• Experience in autoimmune, immunology, or hepatology indications.
• Experience at a small or early-stage biotech, serving as the primary operational contact for a study.
• Experience with first-in-human studies and investigator-initiated or academic site networks.

Who will thrive here

• Someone who enjoys being in the details and takes pride in getting things done, from tracking down a missing regulatory document to resolving a site issue the same day.
• A self-starter comfortable in a fast-paced start-up environment, who takes ownership of tasks without waiting for direction.
• A pragmatic, solution-focused operator who can balance quality and compliance with speed and resourcefulness.
• A genuine team player who leads with collaboration, not ego. You share credit, own your mistakes, and approach problems as “we” rather than “they.”
• Someone who builds trust through direct, respectful communication: you raise concerns openly, give colleagues the benefit of the doubt, and resolve disagreements constructively rather than escalating them.
• A positive contributor to culture who understands that on a small team, every person has an outsized influence, and who wants to help build a workplace rooted in respect, accountability, and mutual support.

Education

• BS/BA in a life science or related discipline and a minimum of 8 years of related experience; or
• MS/MA in a related discipline and a minimum of 6 years of related experience; or
• PhD, PharmD, or RN in a related discipline and a minimum of 4 years of related experience; or
• An equivalent combination of education and experience.