Director, Global Clinical Supply Chain Planning

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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 the Director, Global Clinical Supply Chain Planning based in Cambridge or Lexington, MA reporting to the Vice President, Global Clinical Supply Chain.

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:

• Responsible for managing a team of Clinical Supply Chain planning professionals responsible for fore-casting and planning of drug substance, drug product, finished drug product and all necessary supplies (comparators, ancillary items, etc.) required to conduct clinical studies in accordance with program requirements and applicable GMP and GCP requirements. 
• Responsible for scenario planning, clinical supply recommendations, and risk mitigation through detailed insight of supply and demand issues for programs of high strategic importance, high cost, and/or under constrained supply. Participates in business development activities such as acquisitions and divestures.  Develops and implements strategies to ensure that critical processes run effectively and achieve organizational milestones and performance KPIs
• Lead/Represent GCSC on cross-functional projects to implement new capabilities and improve existing processes/systems

ACCOUNTABILITIES:

• The Director (Team Lead), Global Clinical Supply Chain Planning will be a primary Interface between clinical supply stakeholders, including Clinical Operations, Pharm Sci, GMS, Clinical Supplies operations and Quality Assurance for batch release planning.
• Responsible for leading a team of planning professionals and ensuring robust procedures, tools, and technology are in place to strategically deliver optimum clinical supply to support all Therapeutic Areas (GI, NS, Onc, and RGH), MPG, GMA, PDT, and VBU in a consistent and predictable manner.  Including all Takeda sponsored studies, IISR’s, partnered studies (if applicable), and Post Trial Access (Compassionate Use, Named Patient programs.
• Develop, implement, and optimize standardized processes and the consistent use of standardized tools to support the effective and efficient end to end planning of clinical trial materials.
• Responsible for developing end to end supply plans for innovative medicines in clinical development.
• Lead, develop and optimize processes for utilization of the SmartSupplies Forecasting & Planning tools for estimating initial, changing, and final delivery requirements of DS, DP, and finished IMP needs to support clinical programs.
• Interfaces with Pharm Sci group to ensure that trial supplies are appropriately supported and that appropriate stability programs are in-progress, and/or appropriate expiry dating exists.
• 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.
• Develop Operational Supply Plans for portfolio of development products both internal and acquired through external partnerships. Oversee forecast planning and inventory management of all relevant investigational medicines and comparators for portfolio, leading in matrix of SMEs spanning Takeda supply chain, Takeda pharmaceutical sciences organizations and external partners.
• Lead operational feasibility assessment, scenario analysis and risk mitigation for new clinical protocols, representing the clinical supply chain to global CMC teams and global program teams.
• Lead establishment of enterprise approach to supply/demand modelling, risk identification, and scenario planning for clinical supply chain, lead cross functional planning teams to respond to unplanned events. Develop supply options, facilitate decision making, and communicate updated manufacturing and supply plans to all impacted stakeholders.

EDUCATION AND EXPERIENCE:

• Bachelor's Degree in scientific / technical discipline, or significant job-related experience dealing with global Clinical Supply planning, forecasting and use of IRT. Advanced Degree/Certification preferred.
• 10 or more years relevant Pharmaceutical Industry and/or contract supplier experience is preferred.
• Significant job related experience dealing with global Clinical Supply planning, forecasting, and supervision of staff (required for position managing staff)
• Expert understanding of clinical supply planning, and supply/demand forecasting(APICS Certification or equivalent certifications are preferred.)
• Experience with Medical Devices a plus.
• Advanced knowledge of GxP. Ability to execute exception and change management activities. Recommend process improvements
• Provides input into Interactive Response Technology (IRT) design for randomization, supplying drug to depots and sites.
• Proficiency in computer software applicable to IRT, Excel, MS Project or equivalent project management software
• Drive process improvements at organization and/or enterprise level"
• Ability to balance enterprise perspective with study and project-level deliverables
• Ability to influence stakeholders from many technical disciplines and at many levels
• Ability to apply multiple lenses to analyze and represent complex interdependencies, scenarios, and tradeoffs
• Ability to lead and influence in a matrix organization
• Leadership skills and strategic problem solving ability; ability to predict issues and identify solutions
• Excellent organizational skills: Proactive, management of multiple tasks of varied complexity simultaneously

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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Job Exempt