Hiring: Clinical Supply Chain Director Company: Exelixis Location: Alameda, CA Job Posted Time: 2026-09-17 11:37:32 Target Skills & Keywords : GCP, Microsoft Office About the job Experience: •Technical experience, in drug product manufacturing, analytical testing/QC, and Pharmacy packaging, and labeling operations as required in meeting FDA guidelines. •Has extensive experience in implementing procedures and building infrastructure of a clinical supply chain function. •Demonstrated knowledge of manufacturing and production planning techniques and the tools used in the industry to streamline the planning process. •Demonstrated experience in independently leading all aspects of clinical supplies management for Phase I, II and especially Phase III trials as well as investigator sponsored trials (IST) •Solid functional working knowledge of GMP/GCP/GLP regulations required. Required Skills: •Lead and oversee developing and implementing departmental technical SOPs, business procedures and infrastructure to drive consistent and streamlined processes that improve business effectiveness. •Lead and oversee building vendor capabilities and knowledge to enable vendor selection. •Improves operational oversight at CMO vendors and ensures Exelixis standards are consistently implemented at each clinical supply chain vendor. •Lead and oversee oversight of scheduling and delivery of clinical supplies including strategies for creating label and packaging design, randomization, packaging, labeling and distribution in compliance with Good Manufacturing Practices (GMP) regulations. •Performs supply forecast modeling (short, medium and long-term). Ensures product requirements and costs for the budget are complete and in place for assigned projects. Evaluates the impact of changing the inventory targets, clinical demand, and budget restrictions. Publishes monthly inventory reports for all products. •Manages the inventories based upon targets and various regulatory filings (initial approvals and process changes in all countries). •Oversees activities relating to the labeling, packaging, and distribution plans for each study (e.g., bulk drug products, matching placebo, PK/PD samples, etc.) based on protocol requirements and factors such as regulatory requirements, blinding concerns, ease of handling by the sites and patients, and patient compliance. •Manages the procurement of comparator drug products and matching placebo as required. Qualifications: •BS/BA degree in related discipline and a minimum of thirteen years of related experience; or, MS/MA degree in related discipline and a minimum of eleven years of related experience; or, PhD in related discipline and a minimum of eight years of related experience; or, Equivalent combination of education and experience. •May require certification in assigned area. Compensation: •$164,500 - $234,500 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!