Director, Clinical Pharmacology

Lead the Clinical Pharmacology function within NDCP, representing the function on project teams and guiding clinical pharmacology strategy across development milestones (IND/CTA, EOP2, NDA/sNDA). Design and execute integrated clinical pharmacology and modeling & simulation approaches to inform dose/schedule, RP2D selection, and regulatory submissions. Provide regulatory input documents (protocols, CSR, IB, briefing packages, SCP/SBS, labels) and collaborate with CROs/consultants to complement in-house capabilities. Strong emphasis on population PK, exposure–response, and mechanistic PK/PD modeling using NONMEM, R, and related tools; communicate complex concepts clearly to diverse audiences. Prior experience with oncology assets and regulatory submissions in US/EU/Asia is preferred. Ability to manage internship and fellowship programs; hybrid work arrangement in Redwood City, CA.