Takeda · 16 hours ago
Associate Director, Global Clinical Supply Chain Operations
Lexington, MA
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$154K/yr - $241K/yr
8+ years expTakeda is a patient-focused, innovation-driven pharmaceutical company that empowers its employees to realize their potential through life-changing work. The Associate Director, Global Clinical Supply Chain Operations will provide leadership and direction for planning and executing global clinical supply chain activities, ensuring compliance and timely delivery of clinical trial materials.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
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, SmartSupplies, 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 quality and service level agreements
Processes compliant invoices promptly to ensure optimal value to Takeda
Key interface with Clinical Operations and Regulatory Affairs on all information required for Health Authority Submissions
Evaluate and propose system improvements and technology enhancements/opportunities
Manages and oversees external consultants and third-party vendors, including vendor selection and agreement development, to ensure timely and quality delivery of CTM that meets study protocol, regulatory, and budgetary requirements
Ensures that key project milestones are met across multiple programs; negotiates and communicates supply plan timelines to internal and external customers, partners and GCSC leadership team
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
Coaches and mentors less experienced staff
Evaluate current processes, identify, and implement improvement opportunities and implement business processes related to the Clinical Supplies Team as required
Manages specialized or high profile projects
Serves as a back up to the director when needed
Effectively leads workstream to support departmental initiatives and goals
Qualification
Required
Degree in Pharmacy, other scientific/technical degree, or significant job-related experience
Minimum of 8 years relevant Pharmaceutical Industry and/or Contract/Service Provider experience is preferred
Strong understanding of cGMP requirements
Proficiency in computer software applicable to IRT, Excel and MS Project or equivalent project management software is a plus
Preferred
Experience with oncology a plus
Benefits
Medical, dental, vision insurance
401(k) plan and company match
Short-term and long-term disability coverage
Basic life insurance
Tuition reimbursement program
Paid volunteer time off
Company holidays
Well-being benefits
Up to 80 hours of sick time
Up to 120 hours of paid vacation
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
10001+ employees
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Christophe Weber
President and CEO
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
Recent News
2026-01-14
Pharmaceutical Technology
2026-01-11
Company data provided by crunchbase