Director, Clinical Operations

Role: Director, Clinical Operations leading global oncology clinical trials at a preclinical to early-phase stage company. Responsibilities include serving as study lead for complex first-in-human and dose-escalation oncology studies, managing CROs/vendors, developing study strategies, timelines, budgets, and risk plans, and ensuring regulatory compliance and inspection readiness. The role involves cross-functional collaboration across Clinical Development, Regulatory, Biometrics, and other teams, with an emphasis on operational excellence, process improvements, and alliance management. Qualifications: Bachelor's in Life Sciences, 12+ years in biotech/pharma clinical development, with deep expertise in early-phase oncology trials, including T-cell engagers, bispecifics, or cell therapies. Experience supporting global study start-up, enrollment strategies, and vendor oversight; strong knowledge of FDA, EMA, GxP, ICH-GCP requirements. Preferred: background in novel oncology modalities, international trial management, and supporting regulatory inspections. The position is based in San Francisco with at least 3 days/week onsite and requires domestic and international travel.