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Associate Director, Senior Planning Lead - Clinical Supply Chain
Senior Planning Lead (Associate Director) - Clinical Supply Chain
Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Senior Planning Lead in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Planning Lead working on the Research and Development team, you will be primary interface between clinical supply stakeholders, including Clinical Operations, Pharmaceutical Sciences, GMS, Clinical Supplies operations and Quality Assurance for end to end supply chain planning and management.
- Responsible for developing an end to end supply plan for innovative medicines in clinical development. The Senior Planning Lead will attend clinical project meetings to gather relevant information, translating clinical trial protocol information into a study supply plan, forecast study product requirements, interacting and negotiation with key project stakeholders to provide delivery timelines and budget.
- Maintains enterprise view of clinical supply chain connecting CMC, clinical operations, and commercial manufacturing perspectives across the development portfolio.
- 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.
- The Senior Planning Lead will be a primary Interface between clinical supply stakeholders, including Clinical Operations, Pharmaceutical Sciences, GMS, Clinical Supplies operations and Quality Assurance for batch release planning.
- The position will utilize relevant technology, including the Smart Supplies system to develop scenario based supply options.
- Interfaces with Pharmaceutical Sciences 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.
- Develop and maintain detailed clinical supply models for complex supply scenarios which provides a study baseline against which to monitor assumptions and inventories of finished goods in ongoing clinical trials.
- 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.
- Responsible for execution of Operational Supply Plan throughout development lifecycle, identifying leading indicators of supply risk.
- Liaise among Clinical Operations, Pharmaceutical Sciences, and Procurement disciplines in planning and managing appropriate levels of CTM and comparator supply in partnership with internal and external stakeholders.
EDUCATION, EXPERIENCE AND SKILLS:
- BS degree in scientific / technical discipline, or significant job-related experience dealing with global Clinical Supply planning, forecasting and use of IRT.
- 8+ years relevant Pharmaceutical Industry and/or contract supplier experience is preferred.
- Expert understanding of clinical supply planning, and supply/demand forecasting
- Experience with Medical Devices a plus.
- Strong understanding of cGMP requirements
- Proficiency in computer software applicable to IVRS/IWRS, Excel and MS Project or equivalent project management software is a plus
- 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
- Willingness to travel to various meetings or Takeda sites
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
This job posting excludes CO applicants
Effective November 1, 2021, absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. As of the same date, absent an approved religious or medical reason, US field-based employees, employees must be fully vaccinated in order to continue in their current roles. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. Candidates are encouraged to speak with their recruiter to seek further information on the applicable guidelines for the Business Unit/Function for which they have applied.
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.