Associate Director, Global Clinical Supply Chain Operations jobs in United States
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Takeda · 4 hours ago

Associate Director, Global Clinical Supply Chain Operations

Takeda is a patient-focused, innovation-driven pharmaceutical company committed to transforming the industry. The Associate Director, Global Clinical Supply Chain Operations will lead and manage clinical supply project delivery, ensuring compliance and timely execution of activities in support of global R&D clinical trials.

BiotechnologyHealth CareManufacturingMedicalPharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Providing 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 supportive research or development needs
Coordinating, procuring and managing drug product supply, packaging, labeling, distribution, return, reconciliation, and destruction activities of clinical trial material
Developing and communicating clinical supply project budgets and plans with internal and external customers and suppliers
Collaborating internally and leading Global Clinical Supply Chain group initiatives including participation in the study oversight process for Global Clinical Supply Chain activities
Interpreting clinical trial drug requests and clinical protocols to develop supply packaging strategies, timelines, and budgets
Utilizing the Smart Supplies Database (PMD) for clinical labeling approval, managing inventory, shipments, and drug return activities
Providing input into Interactive Response Technology (IRT) design for randomization and return functionality
Planning work activities with QA/QP personnel to facilitate expeditious release of clinical trial material for shipment
Ensuring trial supplies are appropriately supported with in progress stability programs and/or appropriate expiry dating
Planning, documenting, and facilitating global cross-border supply strategies with Logistics function
Managing and troubleshooting shipment requests, drug returns, SmartSupplies, and IRT processes with GCSC Specialists
Overseeing and coordinating primary and secondary packaging, labeling, testing, distribution, return drug management activities with service providers
Key interface with Clinical Operations and Regulatory Affairs on all information required for Health Authority Submissions
Evaluating and proposing system improvements and technology enhancements/opportunities
Managing and overseeing external consultants and third-party vendors, ensuring timely and quality delivery of CTM that meets study protocol, regulatory, and budgetary requirements
Accountable for amending budgets through defined change management processes and managing all finance activities with the clinical team
Coaching and mentoring less experienced staff
Evaluating current processes, identifying, and implementing improvement opportunities for the Clinical Supplies Team
Managing specialized or high profile projects
Serving as a back up to the director when needed
Effectively leading workstream to support departmental initiatives and goals

Qualification

Pharmacy degreePharmaceutical Industry experienceCGMP knowledgeProject management softwareOncology experienceLeadership skillsCommunication skillsProblem-solving skills

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
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
Well-being benefits
Up to 80 hours of sick time
Up to 120 hours of paid vacation

Company

Takeda

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Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.

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 Company
Total Funding
$2.46B
2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M

Leadership Team

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Christophe Weber
President and CEO
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Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
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Company data provided by crunchbase