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 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 regulatory interactions Work setup fully remote, with occasional domestic travel (~20%). #J-18808-Ljbffr Insmed Incorporated