Medical Director, Safety Sciences
Denali Therapeutics
Summary
This job provides senior clinical leadership for safety strategy and oversight across multiple development programs or a therapeutic area. Leads complex safety assessments, drives cross-functional safety decision-making, and contributes to portfolio-level benefit–risk evaluation.
Job description
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.
Requirements
- 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.
Benefits
- 401(k)
- Healthcare coverage
- ESPP
Company overview
Denali Therapeutics is a pioneering biotechnology company focused on developing innovative therapeutics for neurodegenerative and lysosomal storage diseases. Founded in 2015 and headquartered in South San Francisco, California, the company has developed a proprietary TransportVehicle™ (TV) platform designed to enable biotherapeutics to cross the blood-brain barrier, addressing one of the most significant challenges in treating central nervous system disorders. Denali's pipeline includes promising candidates for conditions such as Hunter syndrome (MPS II), Parkinson's disease, frontotemporal dementia, Sanfilippo syndrome (MPS IIIA), and MPS I, with several programs in advanced clinical development stages. The company collaborates with major pharmaceutical partners including Biogen and Sanofi, leveraging its platform technology to create a new class of barrier-crossing therapeutics. With approximately 500-1,000 employees and operations spanning multiple locations including Salt Lake City, Denali Therapeutics represents a leading force in neuroscience drug development, combining deep scientific expertise with a patient-centric approach to transform treatment paradigms for serious neurological conditions.