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.

• 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

• 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

experience with small molecules and supporting safety in product development.

• oncology focus
• biologics/pharmaceuticals
• late-stage clinical development
• pharmacovigilance leadership
• regulatory inspection support

San Francisco or Boston; minimal travel.