Manager, Global Clinical Supply Chain Operations

GOALS:

• Under the direction of the GCSC Team Lead, the Clinical Supplies Operations Lead responsible for Clinical Supply delivery in support of Takeda R&D Global Clinical Trials and other supportive research or development needs, and works with both internal and external customers and suppliers in order to develop and communicate project budgets and plans and to ensure that all project objectives are met in a timely and compliant manner.
• The Clinical Supplies Operation Lead’s areas of responsibility include coordination and management of the procurement, packaging, labeling, distribution return, reconciliation, and destruction activities of clinical trial materials.
• Leads GCSC group initiatives including the active participation of the study oversight process for GCSC activities to support Takeda’s clinical trial operating model.

ACCOUNTABILITIES:

• Work with GCSC Planning function to interpret clinical trial drug requests and clinical protocols and to develop supply packaging strategies, timelines, and budgets.
• Utilize the Smart Supplies database for clinical labeling approval, to request packaging/labeling/distribution jobs, to manage inventory, shipments, and drug return activities.
• Provide input into Interactive Response Technology (IRT) design for randomization, supplying drug to depots and sites, and for return functionality.
• Interface with GCSC technology and digital team to understand IRT standards and PMD requirements and proactively designs database methodology and/or trouble-shoots potential challenges.
• Interface with appropriate QA/QP personnel to help plan work activities and to facilitate expeditious release of clinical trial material for shipment to sites.
• Interface with the Pharmaceutical Sciences group to ensure that trial supplies are appropriately supported with appropriate in progress stability programs, and/or appropriate expiry dating exists.
• Work closely with Logistics function to pro-actively plan, document, and facilitate global cross-border supply strategies, including requirements associated with controlled substances, compliance to global trade standards, and in-country investigational product regulatory requirements for delivery of product to final destinations.
• Work with GCSC Specialists to manage and troubleshoot shipment requests, drug returns, PMD, and IRT processes. Works with them to ensure creation and maintenance of project documentation according to established procedures and to manage clinical trial material inventory for projects assigned.
• Oversee and coordinate primary and secondary packaging, labeling, testing, distribution, return drug management activities with service providers according to approved budget. Ensures that activities are performed in accordance with statements of work, packaging requests, job orders, regulations and established quality and service level agreements. Processes compliant invoices promptly to ensure optimal value to Takeda.
• Accountable and responsible for amending budgets through defined change management processes. Manages all finance activities with clinical team including request for proposal for bidding and vendor selection, purchase orders and invoice approval. Responsible for forecasting for materials, costs and managing variances across multiple programs with multiple late phase protocols.

EDUCATION AND EXPERIENCE:

• Degree in Pharmacy, other scientific/technical degree, or significant job related experience.
• 4 or more years of relevant Pharmaceutical Industry and/or Contract/Service Provider experience is preferred.
• Experience with Medical Devices a plus.
• Strong understanding of cGMP requirements.
• Proficiency in computer software applicable to IRT, Excel and MS Project or equivalent project management software is a plus.