Senior Director, Patient Safety Sciences

Role: Senior Director, Patient Safety Sciences, leading Olema's safety functions within its oncology development portfolio. Objectives: provide strategic and scientific leadership for patient safety activities across clinical programs, build and develop a high-performing Safety Sciences team, and ensure compliance with regulatory standards. Responsibilities: oversee safety signal detection, risk management strategies, and safety data analysis; develop safety documentation such as benefit-risk assessments, protocols, and regulatory submissions; review serious adverse events and support Data Monitoring Committees; lead quality systems, audits, and inspections; deliver safety training; collaborate with Clinical Development, Regulatory Affairs, and Medical Affairs; and manage vendor relationships. Requirements: MD, PhD, PharmD, or equivalent; 15+ years in drug safety with oncology clinical trial experience; 6+ years of leadership managing safety teams; strong knowledge of ICH, FDA, and EU regulations; experience with registrational trials and regulatory filings; expertise in signal detection, benefit-risk evaluation, and pharmacovigilance audits. Preferred: experience with small molecules and supporting safety in product development. High-Value: oncology focus, biologics/pharmaceuticals, late-stage clinical development, pharmacovigilance leadership, regulatory inspection support. Location: San Francisco or Boston; minimal travel.