Associate Director, Global Clinical Supply Chain Operations

Role Summary

Associate Director, Global Clinical Supply Chain Operations, based in Cambridge, MA. This role provides leadership and direction to facilitate the planning and execution of GCSC activities globally, managing clinical supply project delivery in support of Takeda Global R&D Clinical Trials and other development needs, including coordinating drug product supply, packaging, labeling, distribution, return, reconciliation, and destruction of clinical trial material.

Responsibilities

• Lead and direct planning and execution of GCSC activities globally under the GCSC Director, including managing clinical supply project delivery for Takeda Global R&D Clinical Trials and related development activities.
• Coordinate, procure, and manage drug product supply, packaging, labeling, distribution, return, reconciliation, and destruction of clinical trial material.
• Develop and communicate clinical supply project budgets and plans with internal and external stakeholders to meet objectives in a timely and compliant manner.
• Lead Global Clinical Supply Chain initiatives and participate in study oversight processes.
• Interpret clinical trial drug requests and protocols to develop supply packaging strategies, timelines, and budgets with GCSC Planning.
• Utilize PMD Smart Supplies for labeling approval, packaging/labeling/distribution requests, inventory, shipments, and returns.
• Contribute to IRT design for randomization, depot/site drug supply, and return functionality; align with IRT standards and PMD requirements.
• Coordinate with QA/QP to plan activities and facilitate release of clinical trial material for shipment to sites.
• Coordinate with Pharmaceutical Sciences to support stability programs and expiry dating.
• Plan and facilitate global cross-border supply strategies with Logistics, including controlled substances, trade standards, and regulatory requirements for product delivery to destinations.
• Work with GCSC Specialists to manage shipment requests, returns, SmartSupplies, and IRT processes; maintain project documentation and inventory.
• Oversee packaging, labeling, testing, distribution, and returns with service providers within budget; ensure compliance with SOWs, regulations, and SLAs; process invoices promptly.
• Interface with Clinical Operations and Regulatory Affairs for health authority submissions information.
• Evaluate system improvements and technology enhancements.
• Manage external consultants and vendors, including selection and agreements, to ensure timely, quality CTM delivery; communicate supply plan timelines to stakeholders.
• Amend budgets through change management; manage finance activities including bids, POs, and invoices; forecast materials and costs and manage variances across programs.
• Coach and mentor staff; identify and implement process improvements for the Clinical Supplies Team; manage high-profile projects; serve as back-up to the director when needed.
• Lead workstreams to support departmental initiatives and goals.

Qualifications

• Degree in Pharmacy or other scientific/technical field, or significant relevant experience.
• Minimum of 8 years in the Pharmaceutical Industry and/or Contract/Service Provider experience (preferred).
• Experience with oncology is a plus.
• Strong understanding of cGMP requirements.
• Proficiency in IRT, Excel, and MS Project or equivalent project management software is a plus.

Education

• Degree in Pharmacy, other scientific/technical degree, or significant job-related experience.