Director of Safety Science

Job Summary

A company is looking for a Director or Sr Director, Safety Science.

Key Responsibilities

• Develop and maintain an understanding of the safety profile of assigned product(s) and relevant strategic context
• Provide Safety Science leadership for clinical development programs and integrate safety science strategy with clinical development plans
• Contribute to regulatory authority submissions and represent Medical Drug Safety in communications with health and regulatory authorities

Required Qualifications

• Healthcare professional degree required; MD or PharmD highly preferred
• 6+ years of drug development experience in the pharmaceutical industry, including 4 years in drug safety for oncology clinical development
• Broad understanding of safety, pharmacovigilance, and clinical/patient risk management
• Expert knowledge of regulations governing pharmacovigilance
• Experience interacting with regulatory authorities at various meetings; filing experience preferred