Responsible for developing and executing end to end supply strategy for innovative medicines in clinical development 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
Develop Operational Supply Plans for portfolio of development products both internal and acquired through external partnerships. Accountable for the forecast planning and inventory management of all relevant investigational medicines and comparators for the portfolio. Leads matrix of SMEs spanning the Takeda supply chain, Takeda pharmaceutical sciences organizations and external partners to optimize supply of investigational product and comparators for patients in global clinical trials.
- 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.
- Accountable for developing and maintaining 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 modeling, 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
- Accountable for development and execution of Operational Supply Plan throughout development lifecycle, identifying leading indicators of supply risk and escalating through TPL and GPL to course correct. Responsible for financial and operational oversight of work performed by external partners contributing to development and execution of Operational Supply Plan.
- Accountable for integrated strategy and management of clinical trial materials (investigational product and comparator) for development programs. Responsible for addressing stakeholder requirements from multiple internal and external functions including Clinical Operations, Pharmaceutical Sciences, and Procurement disciplines.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- Bachelor s degree in Life Sciences, Engineering, Pharmacy, Supply Chain/Logistics or related discipline. Advanced degree preferred.
Experience and Capabilities:
- 10+ years of pharmaceutical experience with 7- years experience in clinical supply chain management (preferred), Commercial supply chain management, CMC development, Clinical Operations or related discipline, deep experience working with CMC Teams and managing relationships with CMOs/CROs
- Expert understanding of clinical supply planning, and supply/demand forecasting
- 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
- APICS or equivalent certification is a plus
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Flexibility to attend early meeting or late meetings due to timezone differences
- Requires approximately 5-10 % travel, which may include overnight and international travel to attend meetings, other Takeda sites, external manufactures, and another related travel.