Medical Director / Senior Medical Director, Cell Therapy 

TCR² is building a clinical development team and is seeking a talented and independent physician-scientist to lead the development of its lead candidate TC-210, a mesothelin-directed TRuC™. The (Senior) Medical Director will be responsible for leading the TCR2 sponsored first-in-human and registrational trials for TC-210. The successful candidate will be responsible for designing, implementing, and communicating the clinical development plan for TC-210 to principal investigators, academic sites, regulatory authorities, clinical operations and manufacturing team members, TCR2 senior management and the Board of Directors. 

We are seeking a physician-scientist with a track record of success in Oncology who is goal-oriented and with the capacity to think strategically, communicate effectively, and lead with minimal supervision.

Responsibilities:

  • Lead cross-functional project teams to design and execute oncology clinical studies 

  • Be responsible for the clinical content of all clinical and regulatory deliverables and documents associated with the clinical trials under his/her direct responsibility, including protocols, INDs, CTAs, investigator brochures, CRF’s, annual IND reports, CSR’s and clinical expert reports, among others

  • Lead site initiation visits with clinical trial investigators 

  • Serve as Medical Monitor and as TCR2 medical representative to multiple vendors, CROs, PIs, laboratories and other organizations involved in the execution of clinical trials

  • Responsible for analysis of clinical data, including safety monitoring in collaboration with pharmacovigilance

  • Provide clinical leadership and work collaboratively with both external (medical experts, advisory boards) as well as internal (Research, Translational Sciences, CMC, Clinical Operations, Safety, Regulatory, Medical Affairs, and Commercial) stakeholders

  • Help ensure Clinical Study Team compliance with FDA, EMEA, ICH and GCP guidelines and internal SOPs

  • Organize (and present at) investigator meetings, advisory boards, DMC’s, medical/scientific meetings

Requirements:

  • M.D. degree with Board Certification in Hematology/Oncology and recognized expertise in his/her field

  • At least 5 years of relevant leadership experience in drug development either in industry (preferred) or in academia

  • Demonstrated experience in immuno-oncology

  • Experience in cell therapy clinical trials is preferred

  • Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, and regulatory/clinical development process

  • Excellent management, interpersonal, communication (both written and oral), and problem-solving skills

  • Demonstrated ability to work well in cross functional teams and to thrive in a fast-paced environment

  • Adherence to our corporate values: Patient-focused, Passion, Integrity, Excellence and One Team

Interested candidates should send their resume to careers@tcr2.com