Manager, Global Clinical Supply Chain Operations Lead

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Job Description

Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Manager, Global Clinical Supply Chain Operations Lead in Lexington, MA reporting to the Director, Global Clinical Supply Chain Operations.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.

Here, you will be a necessary contributor to our inspiring, bold mission.

GOALS:

• Under the direction of the Global Clinical Supply Chain (GCSC) Team Lead, the Clinical Supplies Operations Lead responsible for Clinical Supply delivery in support of Takeda R&D Global Clinical Trials and other supportive research or development needs, and works with both internal and external customers and suppliers in order to develop and communicate project budgets and plans and to ensure that all project objectives are met in a timely and compliant manner.
• Areas of responsibility include coordination and management of the procurement, packaging, labeling, distribution return, reconciliation, and destruction activities of clinical trial materials.
• Lead GCSC group initiatives including the active participation of the study oversight process for GCSC activities to support Takeda’s clinical trial operating model.

ACCOUNTABILITIES:

• Work with GCSC Planning function to interpret clinical trial drug requests and clinical protocols and to develop supply packaging strategies, timelines, and budgets.
• Utilize the Smart Supplies database for clinical labeling approval, to request packaging/labeling/distribution jobs, to manage inventory, shipments, and drug return activities.
• Provide input into Interactive Response Technology (IRT) design for randomization, supplying drug to depots and sites, and for return functionality.
• Interface with GCSC technology and digital team to understand IRT standards and PMD requirements and proactively designs database methodology and/or trouble-shoots potential challenges.
• Interface with appropriate QA/QP personnel to help plan work activities and to facilitate expeditious release of clinical trial material for shipment to sites.
• Interface with the Pharmaceutical Sciences group to ensure that trial supplies are appropriately supported with appropriate in progress stability programs, and/or appropriate expiry dating exists.
• Work 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.
• Work with GCSC Specialists to manage and troubleshoot shipment requests, drug returns, PMD, and IRT processes. Work with them to ensure creation and maintenance of project documentation according to established procedures and to manage clinical trial material inventory for projects assigned.
• Oversee and coordinate primary and secondary packaging, labeling, testing, distribution, return drug management activities with service providers according to approved budget. Ensure that activities are performed in accordance with statements of work, packaging requests, job orders, regulations and established quality and service level agreements. Process compliant invoices promptly to ensure optimal value to Takeda.
• Amend budgets through defined change management processes. Manage all finance activities with clinical team including request for proposal for bidding and vendor selection, purchase orders and invoice approval. Forecast for materials, costs and managing variances across multiple programs with multiple late phase protocols.

EDUCATION AND EXPERIENCE:

• Bachelor's Degree in Pharmacy, other scientific/technical degree, or 6 plus years of job related experience required if no degree.
• 4 or more years relevant Pharmaceutical Industry and/or Contract/Service Provider experience is preferred.
• Experience with Medical Devices a plus.
• Strong understanding of cGMP requirements
• Proficiency in computer software applicable to IRT, Excel and MS Project or equivalent project management software is a plus

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

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EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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