Senior Director of Medical Safety

Job Summary

Leading safety teams in all aspects of pharmacovigilance and risk management for a late-stage psychedelic development portfolio, the full-time Senior Director of Medical Safety will provide strategic and operational safety leadership, ensuring the identification and mitigation of safety risks while collaborating with cross-functional teams in a remote setting.

Key responsibilities

• Serves as the medical safety expert for late-stage development products, establishing a robust safety strategy
• Develops and leads safety monitoring approaches and integrated benefit-risk frameworks for psychedelic compounds
• Authors safety content for global regulatory submissions and represents Global Safety in regulatory interactions

Required qualifications

• MD degree (required) with a strong medical background and clinical training
• At least 10 years of experience as a Safety/PV professional in the pharmaceutical industry
• Proven track record of innovation in Medical Safety strategy and execution
• Solid knowledge of FDA and global pharmacovigilance regulations
• Experience preparing and reviewing safety content for global regulatory filings (IND/NDA/MAA)