Sr. Medical Director, Drug Safety and Pharmacovigilance

Role: Senior Medical Director, Drug Safety & Pharmacovigilance, leading safety strategy and risk management for biopharma cell therapy products, including autologous and allogeneic CAR-T, TCR-T, and NK cell platforms, primarily in early to late clinical development stages. Responsibilities: develop and execute pharmacovigilance plans, conduct signal detection and safety assessments, oversee safety data review across sources, and support regulatory submissions and interactions. Lead safety monitoring meetings, manage vendor relationships, and ensure compliance with global regulations (US/EU). Manage internal safety teams and oversee safety reporting, including aggregate reports and risk-benefit evaluations. Requirements: MD or equivalent, 5+ years in pharma drug safety/Vaccovigilance, strong knowledge of US/EU pharmacovigilance regulations, prior experience with IND/NDA/BLA processes, and leadership skills. HighValue: experience supporting cell therapy (CAR-T, TCR) clinical trials, regulatory filings, and safety data analysis; familiarity with biotech development and post-marketing surveillance. WorkSetup: based in Somerset, NJ, with leadership responsibilities across global projects.