Director, Clinical Operations

Role: Lead strategic and operational management of clinical programs within biopharma, focusing on clinical development execution, vendor oversight, and regulatory compliance. Responsibilities: oversee end-to-end clinical trial activities (feasibility, startup, enrollment, conduct, closeout), collaborate with cross-functional teams (Development, Biometrics, Regulatory, QA, Medical, CMC, Legal), manage CROs and vendors, ensure adherence to ICH/GCP and FDA regulations, and maintain inspection readiness. Contribute to development of operational strategies, protocols, and SOPs, and lead a team of clinical operations professionals. Requirements: Bachelor’s degree in life sciences or related field; at least 12 years of progressive experience in clinical operations within biotech/pharma, with strong oncology background, particularly hematological malignancies preferred. Extensive experience managing global Phase I-III trials, vendor relationships, and clinical trial budgets. Knowledge of regulatory standards, quality systems, and trial management tools. Preferred: advanced degree, oncology expertise, and prior leadership in clinical trial execution. High-Value: oncology/hematology, Phase I-III, global trials, vendor oversight, regulatory compliance, inspection readiness. Work Setup: onsite/hybrid in South San Francisco requiring regular onsite presence, with some travel.