Associate Director, Safety Sciences

Denali Therapeutics•South San Francisco, CA

2d•$171,000 - $223,000

About The Position

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. 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.

Requirements

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.

Nice To Haves

Experience mentoring or providing technical guidance to junior scientists preferred.

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.