Senior Medical Director, Safety Sciences
Denali Therapeutics
July 03, 2026
Remote friendly (South San Francisco, CA)
United States
Medical Affairs
Key Accountabilities / Core Job Responsibilities
- Provide strategic safety leadership across multiple programs or a therapeutic area.
- Lead safety signal detection (including complex cases), evaluation, and risk assessment/management across development programs.
- Own and drive benefit–risk assessments for assigned products to inform program and portfolio decisions.
- Oversee preparation and review of aggregate safety reports, regulatory safety submissions, and safety sections of regulatory filings.
- Provide medical review and causality assessment of individual case safety reports.
- Provide senior medical safety leadership in safety governance forums (Safety Review Committees, Data Monitoring Committees).
- Partner with Clinical Development, Regulatory Affairs, and Biostatistics to shape safety monitoring strategies.
- Lead development and implementation of risk management strategies (including RMPs and REMS where applicable).
- Represent Drug Safety in cross-functional program teams and governance discussions.
- Mentor and develop Medical Directors and other safety scientists.
- Contribute to safety process improvements, standards, and best practices.
- Participate in regulatory inspections and internal audits.
Qualifications/Skills
- MD or MD/PhD required.
- 10+ years of relevant experience in drug safety, pharmacovigilance, or clinical development with progression to program/multi-program safety leadership.
- Deep understanding of global pharmacovigilance regulations, signal detection methodologies, and safety risk management.
- Demonstrated ability to influence cross-functional decisions and lead complex safety discussions.
- Recognized clinical and scientific credibility.
Benefits / Application
- Salary range: $315,000.00–$388,333.00; includes 401k, healthcare coverage, ESPP, and other benefits. Learn more: https://www.denalitherapeutics.com/careers
- Provide strategic safety leadership across multiple programs or a therapeutic area.
- Lead safety signal detection (including complex cases), evaluation, and risk assessment/management across development programs.
- Own and drive benefit–risk assessments for assigned products to inform program and portfolio decisions.
- Oversee preparation and review of aggregate safety reports, regulatory safety submissions, and safety sections of regulatory filings.
- Provide medical review and causality assessment of individual case safety reports.
- Provide senior medical safety leadership in safety governance forums (Safety Review Committees, Data Monitoring Committees).
- Partner with Clinical Development, Regulatory Affairs, and Biostatistics to shape safety monitoring strategies.
- Lead development and implementation of risk management strategies (including RMPs and REMS where applicable).
- Represent Drug Safety in cross-functional program teams and governance discussions.
- Mentor and develop Medical Directors and other safety scientists.
- Contribute to safety process improvements, standards, and best practices.
- Participate in regulatory inspections and internal audits.
Qualifications/Skills
- MD or MD/PhD required.
- 10+ years of relevant experience in drug safety, pharmacovigilance, or clinical development with progression to program/multi-program safety leadership.
- Deep understanding of global pharmacovigilance regulations, signal detection methodologies, and safety risk management.
- Demonstrated ability to influence cross-functional decisions and lead complex safety discussions.
- Recognized clinical and scientific credibility.
Benefits / Application
- Salary range: $315,000.00–$388,333.00; includes 401k, healthcare coverage, ESPP, and other benefits. Learn more: https://www.denalitherapeutics.com/careers