Director, Patient Safety (MD)
Core
Lead safety activities for CAR-T clinical development programs, shaping the safety profile of innovative cell therapies and ensuring regulatory compliance.
Role type
Director, Patient Safety Physician (MD)
Builds
Safety strategies, regulatory documents, and risk management plans for oncology cell therapies.
Domain
Biopharmaceuticals / Oncology / Cell & Gene Therapy
Required skills
Drug safety/pharmacovigilance, clinical trial management, benefit-risk assessment, regulatory compliance (FDA/EMA/ICH), cross-functional leadership, safety signal detection, protocol design, data integrity, inspection readiness, strategic planning, SOP development, audit management, business continuity, mentorship.
Preferred skills
Oncology/rheumatology/neurology clinical experience, Cell/Gene Therapy expertise, matrixed environment experience, advanced analytics, real-world evidence utilization.
Technologies
ARISg, Argus, Empirica, Spotfire
Responsibilities
Lead ongoing safety signal detection, evaluation, and benefit-risk assessments; Serve as primary author of safety sections in protocols, Investigator's Brochures, CSRs, DSURs, RMPs; Represent Drug Safety on Global Development and Product Teams; Prepare and lead Safety Review Committee (SRC) and Data Safety Monitoring Board (DSMB) meetings; Present at internal governance forums; Collaborate cross-functionally with Clinical Research, Regulatory, Biostats, Medical Affairs; Ensure data integrity and compliance in safety databases; Drive innovation in safety science; Lead process improvements and safety monitoring standards; Mentor junior safety scientists; Support inspection readiness and regulatory submissions; Lead strategic planning for safety operations.
Seniority
Director, strategic leadership with hands-on clinical oversight