The objective of the Supply Chain Program Lead (SCPL) role in Cell Therapies is to plan and oversee the operational execution of the clinical supply network for one or more Cell Therapies programs in clinical development. SCPL will establish stage and scale appropriate supply strategy that bridges seamlessly among Product, Clinical, and Regulatory functions in the Cell Therapies space and ensure sponsor oversight of the Chain of Custody and Chain of Identity (CoC and CoI) that spans the product journey from vein to vein.
The responsibilities of this role include:
Develop and execute vein to vein (or donor to vein) supply strategy for Cell Therapies programs in clinical development. Responsible for supply chain planning, operations, and execution for Cell Therapy clinical programs. Responsible for oversight of CoC/CoI established and maintained by network of internal partners and external vendors. Provide strategic input and subject matter expertise to the development of clinical development plans, clinical protocols, and/or study-specific work instructions or study manuals to support the operational supply strategy for one or more Cell Therapy clinical programs. Represent the Cell Therapies supply chain at the Global Program Team (GPT) and Clinical Subteam (CST). Participate in Study Execution Team (SET), Product Subteam, Translational Subteam, and other cross-functional working groups as necessary to ensure effective planning, execution, communication and escalation throughout the cell therapy product journey.
●Accountable to the GPT for developing operational supply strategy that optimally supports Clinical Development Plan and Translational Engine strategy and overseeing its execution. ・Identify and assess relevant risk scenarios and provide expert recommendations. ・Evaluate critical program needs (internal and external capabilities, resources, skill sets, etc.), and partners with GPT, Cell Therapy Supply Chain, and other stakeholders to ensure needs are addressed ・Communicate program status, cost, risks, and issues to ensure timely decision-making by GPT
●Collaborate with external strategic partners and other vendors to develop and operationalize clinical supply strategy. ・Key point of contact between GPT and external strategic partners/preferred suppliers. Provide program & study-level direction and support to the strategic partners/preferred suppliers for the development of plans including kitting, labeling, storage, and distribution. ・Responsible for ensuring delivery on time, in budget, and with appropriate quality. ・Collaborate with cross-functional counterparts to oversee the performance for all activities assigned to our strategic partners/other CROs/other vendors, including escalation of issues GPT, to governance committees and to senior management when warranted.