Associate Director, Safety Sciences
Denali Therapeutics
10 days ago
Remote friendly (South San Francisco, CA)
United States
Medical Affairs
Provides scientific support and leadership for safety surveillance, signal detection, and safety data evaluation 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 with Safety Science directors and cross-functional teams. Drives development of safety analyses and contributes to safety strategy for programs.
Key Accountabilities / Core Job Responsibilities
- Leads signal detection and signal evaluation across assigned development programs using clinical trial and post-marketing safety data sources.
- Performs scientific analysis and interpretation of safety data to identify emerging risks and support benefit–risk assessment.
- Partners with Safety Science physicians and cross-functional teams for 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 (e.g., DSURs, PSUR/PBRERs), investigator brochures, and safety sections of regulatory submissions.
- Collaborates with Clinical Development, Nonclinical, Regulatory Affairs, Data Science, and Biostatistics for integrated safety analyses and ongoing safety monitoring.
- Provides scientific leadership in Safety Review Committees and governance activities.
- Refines signal detection methodologies, safety analytics approaches, and safety review processes.
- Provides input into clinical study protocols, safety monitoring plans, and risk mitigation strategies.
- Mentors junior safety scientists and supports safety science best practices.
Qualifications/Skills
- PhD, PharmD, or equivalent advanced degree in life sciences, pharmacy, epidemiology, or related field.
- 10+ years’ experience in pharmacovigilance, safety science, pharmacoepidemiology, or clinical development (biotech/pharma).
- Expertise in signal detection, safety data interpretation, and benefit–risk assessment.
- Experience leading safety science activities for clinical development programs and regulatory safety deliverables.
- Strong understanding of global pharmacovigilance regulations, safety governance, and integrated safety analyses.
- Ability to independently lead complex analyses and influence cross-functional safety discussions (mentoring preferred).
Benefits / Compensation
- Salary range: $171,000–$223,000; competitive total rewards package including 401(k), healthcare coverage, ESPP, and other benefits.
- Learn more: https://www.denalitherapeutics.com/careers
Key Accountabilities / Core Job Responsibilities
- Leads signal detection and signal evaluation across assigned development programs using clinical trial and post-marketing safety data sources.
- Performs scientific analysis and interpretation of safety data to identify emerging risks and support benefit–risk assessment.
- Partners with Safety Science physicians and cross-functional teams for 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 (e.g., DSURs, PSUR/PBRERs), investigator brochures, and safety sections of regulatory submissions.
- Collaborates with Clinical Development, Nonclinical, Regulatory Affairs, Data Science, and Biostatistics for integrated safety analyses and ongoing safety monitoring.
- Provides scientific leadership in Safety Review Committees and governance activities.
- Refines signal detection methodologies, safety analytics approaches, and safety review processes.
- Provides input into clinical study protocols, safety monitoring plans, and risk mitigation strategies.
- Mentors junior safety scientists and supports safety science best practices.
Qualifications/Skills
- PhD, PharmD, or equivalent advanced degree in life sciences, pharmacy, epidemiology, or related field.
- 10+ years’ experience in pharmacovigilance, safety science, pharmacoepidemiology, or clinical development (biotech/pharma).
- Expertise in signal detection, safety data interpretation, and benefit–risk assessment.
- Experience leading safety science activities for clinical development programs and regulatory safety deliverables.
- Strong understanding of global pharmacovigilance regulations, safety governance, and integrated safety analyses.
- Ability to independently lead complex analyses and influence cross-functional safety discussions (mentoring preferred).
Benefits / Compensation
- Salary range: $171,000–$223,000; competitive total rewards package including 401(k), healthcare coverage, ESPP, and other benefits.
- Learn more: https://www.denalitherapeutics.com/careers