At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
- Under the direction of the Planning Team Lead, as the Manager, Planning Lead you are responsible for Clinical Supply delivery in support of Takeda’s R&D Global Clinical Trials and other supportive research or development needs.
- Responsible for developing end to end supply plan for innovative medicines in clinical development. The Manager, 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 assigned clinical programs.
- The Manager, Planning Lead will be a primary Interface between clinical supply stakeholders, including Clinical Operations, Pharmaceutical Sciences (PS), GMS, Clinical Supplies operations and Quality Assurance.
- Provides input into Interactive Response Technology (IRT) design for randomization, supplying drug to depots and sites.
- 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 PS 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 and escalating through PS Lead and GPL to course correct.
- 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.
- Utilizes the ClinApps Clinical Supplies Management Database (CSMD) for clinical labeling approval, to request packaging/labeling/distribution jobs, to manage inventory, shipments, and drug return activities.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Degree in Engineering, Management, Pharmacy or other scientific/technical degree, or significant job-related experience.
- 4+ years relevant Pharmaceutical Industry and/or Contract Provider experience, 2-year Post-PharmD Fellowship experience in, or MBA 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
- 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.
Base Salary Range: $105,000 to $150,000 Range . Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.
The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.
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
USA - MA - CambridgeWorker Type