Associate Director, Safety Sciences

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.