Associate Director or Director Clinical Development Program Management

Role: Senior leadership position (Associate Director/Director, Clinical Development Program Management) overseeing the strategic and operational execution of one or more clinical programs for next-generation CAR T-cell therapies targeting solid tumors and hematologic malignancies. Responsibilities include translating clinical strategy into detailed project plans, managing cross-functional teams (clinical ops, CMC, regulatory, biometrics, quality, pharmacovigilance, medical affairs), and ensuring trial delivery on time, within budget, and compliant with GCP/regulatory standards. The role involves risk mitigation, vendor oversight, supporting regulatory submissions (e.g., BLA/NDA), and driving continuous improvement in project processes. Qualifications: Bachelor's degree in a scientific or healthcare field; 8+ years (Associate Director) or 10+ years (Director) in clinical project management within biotech/pharma, with experience spanning Phase 1-3 trials, preferably in cell therapy or immuno-oncology. Strong leadership in matrixed environments, knowledge of drug development lifecycle, GCP, and regulatory processes required. Preferred: advanced degrees, PMP certification, familiarity with AI-enabled tools, and hands-on experience with project management software like Smartsheet. The position can be based in Seattle, WA, or San Francisco, CA, with a competitive salary range and potential bonuses.