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Manager, Global Clinical Supply Chain Operations Lead

Lexington, Massachusetts
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  • Job Type: Full Time
  • Job Level: Senior
  • Travel: Minimal

At Takeda, we exist to create better health for people and a brighter future for the world. While we continually evolve science and technology, our ambition remains steadfast — we move science forward so we can transform more lives. The Global Development Office (GDO) maintains a laser focus on Study Management and Site Engagement, Clinical Trial Innovation, Clinical Supply Chain and Patient Safety to ensure absolute quality and enable the predictable delivery of our innovative pipeline.

Through its collaborative process, the GDO team leverages data, digital and analytics to improve speed, quality, performance and predictability within every area of clinical development. We’re building a platform to visualize operational data and enable predictive analytics, while leveraging digital technologies to support clinical supply chain and patient safety. GDO also partners with external organizations and leading academic institutions, such as MIT, to spark innovation in AI and Machine Learning focused on better patient outcomes.

At the heart of GDO are our people: we are committed to building a more diverse, equitable and inclusive culture not only within our own walls and our communities, but also across our clinical trials. It is our passion for people that transforms our work into meaningful action. Come join a team that has earned trust for more than two centuries and advances transformative therapies with honesty, integrity and fairness.

Job ID R0131030 Date posted 10/28/2024 Location Lexington, Massachusetts

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

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.

For Location:

Lexington, MA

U.S. Base Salary Range:

$108,500.00 - $170,500.00

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-termincentives. 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
Apply Now

Where you fit in

As a member of GDO, you will play an important role in bringing forward our rich pipeline of life-changing products to help patients. You will find enriching engagement and a mindset of continuous improvement through creativity, innovation and diversity.

We are a global organization present in the U.S., Europe and Asia with colleagues located in several additional countries to strategically support our business needs. But our people, and the culture they build, are the foundation that sets GDO apart. Our belief in putting people first extends beyond patients. It includes their families and communities, and also our Takeda colleagues and our families.

Working closely with GDO colleagues and key stakeholders across R&D, you will leverage our new operating model and innovative technologies to accelerate the development of our current and future portfolio to bring medicines to patients faster.

  • Advance clinical research

  • Deliver clinical analytics and study insights using innovative technologies to improve trial accessibility and patient centricity

  • Enable end-to-end management of clinical supply

  • Ensure safety management and inspection readiness

One of the main reasons I came to Takeda is because of the people I would be working for.We all use PTRB as our North Star. I think that makes it easier to delegate decisions and empower each level of the organization to contribute in a meaningful way.
Marisa Rackley

Marisa Rackley - Head, Clinical Site Startup & Engagement, Global Development Office

It’s leveraging technology, it’s leveraging data in a very different way. It’s not just about using the data that we generate, but using real world data and having access to a much more holistic set of data in order to drive the way we work and deliver medicines to patients.
Penny Carlson

Penny Carlson - Head of Innovation and Data, Global Development Office

The culture at Takeda is very unique. It’s a culture that’s extremely collaborative in nature, requiring people from diverse backgrounds to come together, speak up, and really think about the most important thing we need to do for our patients.
Saurabh Awasthi

Saurabh Awasthi - Executive Director, Trial Insights & Performance Optimization, Global Development Office

The heart of our work

Shining a light on new perspectives

Our pipeline

Our internal research capabilities and external partnerships contribute to an R&D engine that has produced exciting new molecular entities (NMEs) across our core Therapeutic Areas. Check out our pipeline and see how we’ll continue delivering a steady stream of next-generation therapies.

Learn more

What we believe in

Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

  • Integrity

  • Fairness

  • Honesty

  • Perseverance

Working at Takeda

  • Inclusion

    Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
  • Collaboration

    A strong, borderless team, we strive together towards our priorities and inspiring mission.
  • Innovation

    Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
  • Top Workplace

    Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024.
  • Work-Life

    Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
  • Empowerment

    Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

We're Steadfast In Our Commitment to Four Key Imperatives

Patient


Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.

People


Create an exceptional people experience.

Planet


Protect our planet.

Data & Digital


Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.

Exterior of Takeda Building

About our location

Lexington, Massachusetts


View Map of Lexington, Massachusetts

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