Medical Director, Safety Sciences

Denali Therapeutics•South San Francisco, CA

44d•$272,000 - $336,000

About The Position

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.

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.

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.