Senior Director, Patient Safety Sciences

Role: Senior Director, Patient Safety Sciences at Olema Oncology, responsible for leading and developing the safety science function across the company's oncology portfolio. Responsibilities include strategic planning and execution of patient safety activities, signal detection, risk management, safety data review, and regulatory document authoring. The role entails overseeing safety aspects in clinical trials, supporting audits and inspections, and building a high-performing safety team. Requirements: MD, PhD, PharmD, or MD equivalent, with at least 15 years of drug safety experience in biopharma, including 6+ years in leadership roles. Oncology experience, particularly with small molecules, and familiarity with regulatory guidelines (ICH, FDA, EU) are essential. Preferred skills include expertise in pharmacovigilance, safety data assessment, and regulatory submissions like DSURs and safety reports. High-Value: Oncology, breast cancer, ER+/HER2- indication, Phase 3 trial oversight, pharmacovigilance, risk management, GxP compliance, and cross-functional collaboration. Work setup: Office-based in San Francisco or Boston with minimal travel.