Cell Therapies Supply Chain Program LeadApply Now Email Me Job ID R0014169 Date posted 11/07/2019 Location: Fujisawa, Japan
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.
- Provide program-level direction and support to the Logistics Coordinator / Supply Chain Coordinator / CMO interface in development and execution of supply chain operational plan including communication with multiple internal and external stakeholders and vendors.
- Accountable for program-level sponsor oversight of to ensure the appropriate establishment, maintenance, and documentation of CoC/CoI
- For certain types of studies and programs, SCPL may have the following responsibilities:
- Integrating CMC and clinical perspectives to develop program-level operational plans
- Developing study-specific communication and escalation plans bridging between Product and Clinical functions
- Identifying and escalating to GPT risks and issues that impact either production or administration of cellular therapy product in a clinical study
- Developing labels for autologous cell therapy products that meet regulatory and CoC/CoI requirements, creating distribution and transportation strategy for patient starting materials and manufactured CTM
- Collaborating with clinical operations, Clinical QA, and IMP QA to assess site feasibility and capability to perform specific procedures related to Cell Therapy supply chain operations (i.e. Aphersis collection, cryostorage of CTM, CoC/CoI maintenance). Work with sites to ensure successful operational outcomes.
- Authoring Cell Handling Manual and/or Pharmacy Manual with input from Clinical Operations, clinical sites, and Cell Therapies Product team
- Designing, approving, socializing, and troubleshooting program or study-specific supply chain workflows (i.e. cell orchestration platform configurations, study-specific communication or contingency plans)
- Work with Procurement & Legal to qualify new supply chain vendors based on program needs and when appropriate, manage vendors for duration of a program or study. Collaborate with Cell Therapies Supply Chain and Operations team to define future state preferred partners/ vendor network
- Contribute to functional strategic initiatives and process improvement
- Actively seek new ways of working more efficiently to meet the needs of the Cell Therapy Supply Chain
- Act as a role model for Takeda´s values
- May include direct management, including coaching, training and performance management of Logistics Coordinator, Supply Chain Coordinator or CMO Interface
- May participate in Business Development/in-licensing/alliances evaluations by providing operational due diligence
- Bachelor’s degree in Life Sciences, Engineering, Pharmacy, Supply Chain/Logistics or related discipline. Advanced degree preferred.
Experience and Capabilities:
- 8+ years of pharmaceutical experience with 5+ years experience in clinical supply chain management, commercial supply chain management, Cell Therapy Development, Clinical Operations, CMC development, or related discipline. Deep experience working with multidisciplinary project teams and and managing relationships with CMOs/CROs preferred.
- Ability to influence stakeholders from many technical disciplines and at many levels
- Ability to apply multiple lenses to analyze and represent complex interdependencies, scenarios, and tradeoffs
- Ability to lead and influence in a matrix organization
- Leadership skills and strategic problem solving ability; ability to predict issues and identify solutions
- Excellent organizational skills: Proactive, management of multiple tasks of varied complexity simultaneously