Medical Director, Drug Safety

Job Summary

Medical Director, Drug Safety is a full-time position responsible for managing safety aspects of clinical studies, providing medical insights, and ensuring integration of drug safety strategies in development programs.

Key Responsibilities

• Provide pharmacovigilance and medical leadership for clinical programs to ensure timely delivery of clinical deliverables
• Serve as the primary safety expert for assigned projects and oversee patient safety in clinical studies
• Engage with health authorities and contribute to regulatory documents related to safety issues

Qualifications

• MD required; board certification in a medical specialty preferred
• Active medical license desirable
• 5+ years of relevant experience in the biotech or pharmaceutical industry, with oversight of Phase 2 and 3 studies
• Experience in leading safety aspects of clinical studies on cross-functional teams
• Psychiatry or neurology drug development experience preferred