Clinical Supply Chain Director

SUMMARY/JOB PURPOSE

The Clinical Supplies Director is responsible for developing and implementing clinical supply chain procedures and infrastructure to support the upcoming pipeline of both small molecule and biologics projects. Also responsible for developing clinical supply chain strategies ensuring availability of supply through development and commercial launch, as well as transferring sustaining activities to the appropriate site planning and procurement teams. This individual also ensures uninterrupted supplies throughout the duration of a clinical study program based upon related targets and regulatory requirements in addition to providing CMO vendor oversight.

• Responsible for developing and implementing departmental technical SOPs, business procedures and infrastructure to drive consistent and streamlined processes that improve business effectiveness.
• Responsible for 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.
• Responsible for 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.
• Helps prepare needed manuals for study drug, PK and PD samples.
• Ensures distribution arrangements are in place to allow shipment following availability of technical and regulatory releases.
• Oversees the record maintenance, protocol evaluation, coding of samples, and storage of approved materials. Ensures that batch records and clinical supplies database are maintained.
• Works collaboratively with other Pharmaceutical Sciences functions, Clinical and Non-Clinical Teams in the strategic sourcing of vendors to support the development supply chain.

• Mentors teammates and leads in a matrix environment.

• 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.

• 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…