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.
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.
Salary Range: $315,000.00 to $388,333.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers
This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.
