Senior Director, Molecule Global Regulatory Lead

Role: Senior Director, Molecule Global Regulatory Lead, responsible for shaping and executing global regulatory strategies for late-stage oncology therapeutics targeting RAS mutations. Responsibilities include developing innovative pathways from IND-enabling stages through registration and lifecycle management, leading health authority interactions (FDA, EMA, PMDA, MHRA), and overseeing major regulatory submissions such as INDs, CTAs, and approvals. The role entails building regulatory frameworks, providing strategic guidance for clinical development plans, and cross-functional leadership to integrate regulatory insights into program execution. Requirements: Advanced scientific degree (PhD, PharmD, MD), 12+ years in biotech/pharma regulatory affairs, especially in oncology, with proven experience managing global regulatory strategies, INDs, and health authority engagements. Preferred: Experience with targeted oncology therapies, acceleration pathways like Breakthrough Therapy or PRIME, and global registration processes. The position reports to the Head of Regulatory Sciences, involves collaboration with clinical, CMC, biometrics, and commercial teams, and is based in Redwood City, CA, with the salary range of $244,000-$305,000 USD.