Director, Clinical Science

Role: The Director, Clinical Science, leads scientific oversight of Lyell’s cell therapy clinical trials, focusing on study medical monitoring, protocol design, data interpretation, and regulatory documentation. Responsibilities: partner with medical monitors for trial oversight (initially PiNACLE and PiNACLE-H2H studies), support protocol development, ensure GCP compliance, monitor patient safety, coordinate data analysis and publications, and contribute to regulatory submissions. Collaborates cross-functionally with Clinical Operations, Biostatistics, Regulatory Affairs, and external stakeholders (investigators, CROs, KOLs). Identifies opportunities for trial innovation and risk mitigation. Qualifications: PhD, PharmD, or related degree; 10+ years in clinical or research settings, with at least 4 years in clinical development, preferably in oncology, cell therapy, or immuno-oncology. Skills include trial design, regulatory expertise, data analysis, and strong communication. Experience supporting complex clinical trials, with familiarity in GCP and regulatory guidelines, is essential. HighValue: focus on cell therapies for solid tumors and hematologic malignancies, clinical-stage (pivotal studies), with an emphasis on immuno-oncology modalities. Location: Seattle, WA or South San Francisco, CA; remote flexibility possible.