Associate Director, Drug Safety Physician

Role: Lead drug safety and pharmacovigilance activities for oncologic and precision medicine therapies, providing medical expertise across clinical trial and post-marketing safety cases. Responsibilities include comprehensive medical review of ICSRs, aggregate safety data analysis, signal detection using advanced methodologies, and authoring regulatory safety reports such as DSURs, PADERs, and safety summaries. The role involves developing safety strategies for novel modalities like targeted therapies and ADCs, guiding departmental policies, and managing cross-functional stakeholder relationships. Requirements: MD or equivalent, 8-12 years in drug safety/pharmacovigilance within biopharma, with 3-4 years in leadership roles. Expertise in oncology drug development, biomarker-driven safety, global regulatory standards (ICH, FDA, EMA, GVP), and complex safety data analysis is essential. Preferred skills include experience with innovative therapeutic modalities, biomarker integration, and regulatory interactions. HighValue: Oncology, precision medicine, biologics, targeted therapies, ADCs, biomarker-driven safety, IND/post-marketing phases, global pharmacovigilance compliance. WorkSetup: Hybrid at South San Francisco HQ, with flexible remote options and regular onsite presence for collaboration.