Director, Medical Safety Lead - DSPV, Gene Therapy

Role: Director, Medical Safety Lead - DSPV Gene Therapy, responsible for safety surveillance, risk management, and communication for gene therapy products. Core responsibilities include evaluating safety data from multiple sources, leading safety review teams, contributing to regulatory and development documents, developing risk management strategies, and providing expert safety input across functions. Qualifications: MD or DO with 5+ years in drug safety/pharmacovigilance, experience with clinical and post-marketing safety data, regulatory guidelines knowledge, and excellent communication skills. Preferred: MPH, clinical care experience, gene therapy or database expertise, product defense experience. High-value specifics: gene therapy modality, safety data review from preclinical to post-marketing, involvement in benefit-risk assessments, safety documentation, and regulatory interactions. Work setup: fully remote, with occasional domestic travel (~20%).