Provides scientific support and leadership for safety surveillance, signal detection, and safety data evaluation activities across assigned clinical development programs. Leads interpretation of clinical and post-marketing safety data to support emerging risk assessment and program-level benefit-risk evaluation in partnership with Safety Science directors and cross-functional development teams. Drives development of safety analyses and contributes to safety strategy for programs. Operates with substantial independence while influencing cross-functional decisions related to product safety and risk management.
Key Accountabilities / Core Job Responsibilities:- Leads signal detection and signal evaluation activities across assigned development programs using clinical trial and post-marketing safety data sources aligned with the program's overall safety strategy.
- Performs scientific analysis and interpretation of safety data to identify emerging risks and support benefit-risk assessment activities.
- Partners with Safety Science physicians and cross-functional teams to support safety strategy development and safety issue management.
- Leads preparation of safety analyses, signal management documentation, and safety governance materials for internal review and regulatory reporting.
- Contributes to aggregate safety reports including DSURs, PSUR/PBRERs, investigator brochures, and safety sections of regulatory submissions.
- Collaborates with Clinical Development, Nonclinical, Regulatory Affairs, Data Science, Biostatistics and to support integrated safety analyses and ongoing safety monitoring.
- Provides scientific leadership in Safety Review Committees, signal management forums, and other cross-functional governance activities.
- Contributes to refinement of signal detection methodologies, safety analytics approaches, and safety data review processes.
- Provides scientific input into clinical study protocols, safety monitoring plans, and risk mitigation strategies.
- Mentors junior safety scientists and contributes to development of safety science best practices within the organization.
Qualifications/Skills:- Typically requires a PhD, PharmD, or equivalent advanced scientific degree in life sciences, pharmacy, epidemiology, or a related discipline.
- Typically requires 10+ years of experience in pharmacovigilance, safety science, pharmacoepidemiology, or clinical development within the biotechnology or pharmaceutical industry.
- Demonstrated expertise in signal detection, safety data interpretation, and benefit-risk assessment methodologies.
- Experience leading safety science activities for clinical development programs and contributing to regulatory safety deliverables.
- Strong understanding of global pharmacovigilance regulations, safety governance processes, and integrated safety analyses.
- Demonstrated ability to independently lead complex scientific analyses and influence cross-functional safety discussions.
- Experience mentoring or providing technical guidance to junior scientists preferred.
Salary Range: $171,000.00 to $223,000.00 . 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.
