Director, Medical Safety Lead - DSPV, Gene Therapy

Responsibilities

• Conduct safety signal detection and manage safety information
• Lead Safety Review Team(s) and assess benefit-risk profiles
• Provide safety review input into clinical development documents
• Strategy development for safety and benefit-risk management
• Write and review periodic safety reports for assigned products
• Collaborate with various internal teams on safety matters
• Ensure regulatory compliance on safety communication and labeling

Qualifications

• MD or DO required with 5+ years in Drug Safety/Pharmacovigance
• Proficiency in scientific document preparation from large data sets
• Knowledge of international Pharmacovigilance guidelines
• Experience presenting to regulatory authorities or at industry events
• Exceptional verbal and written communication skills
• Strong attention to detail and organization

Benefits

• Comprehensive medical, dental, and vision coverage with mental health support
• Generous paid time off, fertility and family-forming benefits, and caregiver support
• 401(k) with competitive match, equity awards, and stock purchase program
• Access to learning and development programs, including mentorship
• Employee resource groups and opportunities for community engagement