Associate Director, Global Clinical Supply Chain Operations

Overview

Job Level: Senior

Travel:
Minimal (if any)

Takeda has been translating science into breakthrough medicines for 240 years. Every step of the way, our teams have worked together to tackle some of the most challenging problems in drug discovery and development. Today, we’re a driving force behind innovative therapies that make a lasting difference to millions of patients around the world.

In R&D, all of our history and potential comes together in an environment that welcomes diversity of thought and amplifies every voice. Working closely with colleagues, you’ll play a key role in bringing our rich pipeline of products forward to help patients. Come join a team that’s earned trust for more than two centuries, and find out how advancing transformative therapies at Takeda will shape your bright future.

Job  R0172406
• Date posted 01/15/2026
• Location Lexington, Massachusetts

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• The Associate Director, GCSC Operations is responsible for providing leadership and direction to facilitate the planning and execution of GCSC activities globally. Under the direction of the GCSC Director, the Associate Director manages Clinical Supply project delivery in support of Takeda Global R&D Clinical Trials and other supportive research or development needs; coordinates, procures and manages drug product supply, packaging, labeling, distribution, return, reconciliation, and destruction activities of clinical trial material.
• Works with both internal and external customers and suppliers to develop and communicate clinical supply project budgets and plans and to ensure that all project objectives are met in a timely and compliant manner.
• Provides expertise, collaborates internally and leads Global Clinical Supply Chain group initiatives including the active participation of the study oversight process for Global Clinical Supply Chain activities.

• Works with GCSC Planning function to interpret clinical trial drug requests and clinical protocols and to develop supply packaging strategies, timelines, and budgets.
• Utilizes the Smart Supplies Database (PMD) for clinical labeling approval, to request packaging/labeling/distribution jobs, to manage inventory, shipments, and drug return activities.
• Provides input into Interactive Response Technology (IRT) design for randomization, supplying drug to depots and sites, and for return functionality. Understands IRT standards and PMD requirements and proactively designs database methodology and/or trouble-shoots potential challenges.
• Interfaces with appropriate QA/QP personnel to help plan work activities and to facilitate expeditious release of clinical trial material for shipment to sites.
• Interfaces with Pharmaceutical Sciences group to ensure that trial supplies are appropriately supported with in progress stability programs, and/or appropriate expiry dating.
• Works 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.
• Works with GCSC Specialists to manage and troubleshoot shipment requests, drug returns, Smart Supplies, and IRT processes. Works with them to ensure creation and maintenance of project documentation and according to established procedures and to manage clinical trial material inventory for projects assigned.
• Oversees and coordinates 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…