Associate Director, Global Clinical Supply Chain Operations Lead

Provides leadership and direction to facilitate the planning and execution of Global Clinical Supply Chain (GCSC) activities. 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 internal and external customers and suppliers to develop and communicate clinical supply project budgets and plans, ensuring project objectives are met in a timely and compliant manner. May have personnel management and compensation planning responsibility and contributes to cross-functional teams and GCSC initiatives.

Responsibilities

• Interpret clinical trial drug requests and protocols to develop supply packaging strategies, timelines, and budgets in collaboration with the GCSC Planning function.
• Utilize the Smart Supplies Database (PMD) for clinical labeling approval, packaging/labeling/distribution job requests, inventory management, shipments, and drug return activities.
• Provide input into Interactive Response Technology (IRT) design for randomization, drug supply to depots/sites, and return functionality; troubleshoot potential challenges.
• Interface with QA/QP personnel to plan work activities and facilitate the release of clinical trial material for shipment.
• Ensure trial supplies are supported by appropriate stability programs and expiry dating through collaboration with the Pharmaceutical Sciences group.
• Plan, document, and facilitate global cross-border supply strategies, including compliance with controlled substances regulations, global trade standards, and in-country investigational product requirements.
• Manage and troubleshoot shipment requests, drug returns, SmartSupplies, and IRT processes with GCSC Specialists; ensure project documentation and inventory are maintained.
• Oversee primary/secondary packaging, labeling, testing, distribution, and return drug management with service providers according to approved budgets, statements of work, and quality agreements.
• Process compliant invoices promptly to ensure optimal value for Takeda.
• Serve as a key interface with Clinical Operations and Regulatory Affairs for Health Authority Submission requirements.
• Evaluate and propose system improvements, technology enhancements, and process optimization opportunities.
• Manage external consultants and third-party vendors, including vendor selection, agreement development, and ensuring timely, quality delivery of clinical trial materials.
• Negotiate and communicate supply plan timelines to internal/external stakeholders and GCSC leadership; ensure key project milestones are met across multiple programs.
• Amend budgets through defined change management processes; manage finance activities including RFPs, vendor selection, purchase orders, and invoice approval.
• Forecast materials and costs, managing variances across multiple late-phase protocols.
• Coach and mentor less experienced staff; evaluate and implement process improvements for the Clinical Supplies Team.
• Manage specialized or high-profile projects; serve as a backup to the director as needed.
• Lead workstreams to support departmental initiatives and goals.

Requirements

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

Benefits

• Eligibility for short-term and long-term incentives.
• Medical, dental, and vision insurance.
• 401(k) plan with 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 per calendar year.
• New hires eligible to accrue up to 120 hours of paid vacation per year.

Pay

U.S. Base Salary Range: $154,400.00 - $242,550.00. The actual base salary offered may depend on qualifications, experience, skills, education, location, and other factors.

Schedule

This position is classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy. Full-time, exempt.