Senior Director, Patient Safety Sciences

Role: Lead and oversee Olema's Patient Safety Sciences function, providing strategic and scientific leadership in pharmacovigilance activities across the oncology portfolio. Responsibilities: develop safety strategies, manage signal detection, safety assessments, and oversight of safety documentation; review serious adverse events and safety data; lead safety activities in Data Monitoring Committees; ensure compliance through audits and inspections; build and mentor a high-performing safety team; collaborate with clinical, regulatory, and medical colleagues to integrate safety into program strategies; and manage vendor relationships. Requirements: MD, PhD, PharmD, or MD equivalent; 15+ years in drug safety within biopharma, with at least 6 years in leadership roles; extensive experience in oncology clinical trials, including small molecules; deep knowledge of ICH, FDA, and EU regulations; proven track record in safety signal detection, risk management, and regulatory interactions. Preferred: experience supporting regulatory submissions and safety documentation for registrational programs in oncology. HighValue: oncology (metastatic breast cancer), pharmacovigilance, clinical trial safety, regulatory compliance, safety documentation, signal detection, data review, leadership in pharmacovigilance. WorkSetup: based in San Francisco or Boston, minimal travel.