Associate Director, Global Clinical Supply Chain Operations Lead

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Job Description

OBJECTIVES/PURPOSE:

• The Associate Director, GCSC Operations Lead 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.

• The Associate Director, GCSC Operations Lead may also have personnel management and compensation planning responsibility and contributes actively to cross functional teams as required.

• 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.

ACCOUNTABILITIES:

• 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-profileprojects
• Serves as a back up to the director when needed
• Effectively leads workstream to support departmental initiatives and goals

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• 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.
• 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

This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work polic

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.

For Location:

Lexington, MA

U.S. Base Salary Range:

$154,400.00 - $242,550.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

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.

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.

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.