Senior Medical Director, Safety Sciences
Denali Therapeutics
4 months ago
Remote friendly (South San Francisco, CA)
United States
Medical Affairs
Key Accountabilities / Core Job Responsibilities
- Provides strategic safety leadership across multiple programs or therapeutic area.
- Leads safety signal detection (including complex cases), evaluation, and risk assessment and management activities across development programs.
- Owns and drives benefit–risk assessments for assigned products and informs program and portfolio decisions.
- Oversees preparation and review of aggregate safety reports, regulatory safety submissions, and safety sections of regulatory filings.
- Provides medical review and causality assessment of individual case safety reports.
- Provides senior medical safety leadership in safety governance forums, including Safety Review Committees and Data Monitoring Committees.
- Partners with Clinical Development, Regulatory Affairs, and Biostatistics to shape safety monitoring strategies for clinical programs.
- Leads development and implementation of risk management strategies, including Risk Management Plans (RMPs) and REMS where applicable.
- Represents Drug Safety in cross-functional program teams and governance discussions.
- Mentors and develops Medical Directors and other safety scientists within the function.
- Contributes to safety process improvements, standards, and best practices across the organization.
- Participates 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 or 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.
Compensation/Benefits (as stated)
- Salary Range: $315,000.00 to $388,333.00.
- Competitive total rewards package including 401k, healthcare coverage, and ESPP, plus other benefits.
Application Instructions
- Learn more: https://www.denalitherapeutics.com/careers
- Provides strategic safety leadership across multiple programs or therapeutic area.
- Leads safety signal detection (including complex cases), evaluation, and risk assessment and management activities across development programs.
- Owns and drives benefit–risk assessments for assigned products and informs program and portfolio decisions.
- Oversees preparation and review of aggregate safety reports, regulatory safety submissions, and safety sections of regulatory filings.
- Provides medical review and causality assessment of individual case safety reports.
- Provides senior medical safety leadership in safety governance forums, including Safety Review Committees and Data Monitoring Committees.
- Partners with Clinical Development, Regulatory Affairs, and Biostatistics to shape safety monitoring strategies for clinical programs.
- Leads development and implementation of risk management strategies, including Risk Management Plans (RMPs) and REMS where applicable.
- Represents Drug Safety in cross-functional program teams and governance discussions.
- Mentors and develops Medical Directors and other safety scientists within the function.
- Contributes to safety process improvements, standards, and best practices across the organization.
- Participates 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 or 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.
Compensation/Benefits (as stated)
- Salary Range: $315,000.00 to $388,333.00.
- Competitive total rewards package including 401k, healthcare coverage, and ESPP, plus other benefits.
Application Instructions
- Learn more: https://www.denalitherapeutics.com/careers