TAKEDA PHARMACEUTICALS AMERICA, INC. · 2 days 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 Pharmaceuticals America, Inc. is a leading company in the pharmaceutical industry, focusing on innovative therapies that improve patient outcomes. The Associate Director, Global Clinical Supply Chain Operations will provide leadership in managing clinical supply project delivery to support global R&D clinical trials, ensuring compliance and timely execution of supply chain activities.
Pharmaceuticals
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
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
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
U.S. based employees may be eligible for short-term and/ or long-term incentives.
U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
Company
TAKEDA PHARMACEUTICALS AMERICA, INC.
TAKEDA PHARMACEUTICALS AMERICA, INC.
10001+ employees
H1B Sponsorship
TAKEDA PHARMACEUTICALS AMERICA, INC. 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
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Trends of Total Sponsorships
2025 (6)
2024 (7)
2023 (9)
2022 (1)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Catherine Fintzel MBA PMP
Sr. Business Partner
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