Sr. Medical Director, Drug Safety

Role Summary

The Sr. Medical Director, Drug Safety is responsible for the overall risk management and safety strategy of assigned products, including internal and external engagement with key collaborators. This role chairs safety governance, helps define safety profiles, and collaborates with regulatory and clinical teams to establish safety strategies for marketing authorization applications and regulatory interactions.

Responsibilities

• Oversight and understanding of all aspects of the assigned product’s safety profile from clinical development to post-approval safety surveillance, including management of CROs and other partners that provide clinical and safety data
• Chair of the Safety Management Committee for designated product(s), identifying emerging safety trends, defining the safety profile, and recommending safety actions based on cumulative safety data
• In collaboration with regulatory and clinical development teams, establish the safety strategy for marketing authorization applications, including preparation of CTD documents, engagement with regulatory authorities, and authoring responses to inquiries
• Support the clinical development team in the review of key documents, including protocol and ICFs
• Manage drug safety contract service organizations (CROs) to ensure expedited reporting, timely and scientifically sound DSUR preparation, and alignment of CRO safety functions with corporate goals and KPIs
• Assist in the medical review of adverse event reports; manage preparation and submission of drug safety expedited reporting when necessary
• Develop and prepare assessments of safety data, safety signals, and benefit/risk for internal senior management as well as external partners or regulatory authorities
• Assist in the authoring of aggregate reports

Qualifications

• Required: Medical Degree
• Preferred: 10 years of drug safety and pharmacovigilance experience (clinical trials safety experience in biotechnology, pharmaceutical, or drug safety CSO)
• Experience with all aspects of safety signal evaluation, including data review/analysis, cross-functional collaboration, regulatory correspondence, and safety label updates
• Experience in both clinical development and post-marketing safety
• Experience with regulatory submissions for NDAs, EU MAAs, and other countries’ regulatory reviews

Skills

• Strong clinical development and post-marketing safety expertise
• Regulatory affairs and safety reporting proficiency
• Ability to lead cross-functional teams and safety governance processes
• Analytical skills for safety signal evaluation and risk assessment

Education

• Medical Degree

Additional Requirements

• Remote role based in the U.S.; typically requires three visits per year to the San Francisco Office or as needed