Vice President, Franchise Clinical Lead, Oncology

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Job Description

About the role:

Responsible for leading as the Vice President, Franchise Clinical Lead, Oncology that encompass multiple late stage and early phase programs. Ensures ongoing review and agreement of the Therapy Area Strategy and associated documents formulated by the Oncology Therapeutic Area Unit (OTAU) leader prior to their review and approval by appropriate governance committees. Oversees the development and execution of the Integrated Disease Area Strategy (IDAS) and overall Integrated Global Development Plan (IGDP). Responsible for review of synopses, other relevant clinical study documents, and critical Study Results. Provide leadership and oversight of specific OTAU related programs and if applicable other indication specific clinical leads. Responsible for providing guidance to TA leaders on regional specificities within Therapeutic Area.

How you will contribute:

• Clinical Development team participation and leadership

• Accountable to Oncology Clinical Science Head to provide strategic clinical input on assigned clinical studies
• Consistent with the Takeda R&D Oncology Therapeutic Area Unit strategy, goals and objectives, this leader will partner with the other key functions and leaders and members of Oncology Precision and Translational Medicine, Oncology Portfolio Strategy Group, Global Regulatory Affairs, Quantitative and Clinical Pharmacology, other R&D Functional Line Oncology Therapeutic Area Leads, Global Product Launch Strategy Oncology Franchise Leads, Regional Oncology Franchise Leads, Oncology Drug Development Unit (DDU) and other Oncology extended leadership, to drive the alignment on global clinical research and development strategy as related to internal and external pipeline and non-pipeline initiatives for the Takeda R&D Oncology Community across all regions
• Part of the Oncology Clinical Sciences Leadership Team providing key input in strategic planning and connectivity for the overall Oncology Clinical Sciences group: Leads the Global Development Team (US, EU, and others) managing both the US/EU Development Team and the Japan/ China Development team for assigned compounds. In some cases may lead the US/EU Development Team but more likely will oversee the study physician and/or clinical scientist leads responsible for leading the team. Emphasis will be on insuring that the development teams are proactively identifying contingencies, potential risks and strategies to address future obstacles. Directs Development Team strategy and deliverables overseeing the Development Strategy, Clinical Development Plan and Clinical Protocols. Recommends scope, complexity and size, which influence the budget of all aspects of a program. Provides continual critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them. Responsible for high impact global decisions: interpreting data from ongoing internal and external studies, assessing the medical and scientific implications and making recommendations that impact regional and global development such as “go/no go” decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling. Plans clinical development strategies in context of medical/clinical significance considering how a given product will fit in with current treatments, standard of care, and unmet medical need
• Accountable for ensuring regional strategies and trade-offs in regional requirements are well articulated in the global strategy documentation and that stakeholders are appropriately briefed
• Providing strategic input into global development strategies and plans for all compounds in OTAU
• Providing clinical and strategic support to evaluation of external compounds (alliances and in-licensing opportunities)
• Primary interface with Medical Affairs team for strategy and to support of product commercial efforts
• Contributing to the creation and maintenance of regional KOL network
• Providing recommendations for GDT leader nominations and reviewers of external compounds as part of business development efforts
• Liaison with Clinical Operations and Project Management for co-ordination of logistics study planning and implementation

• Synopsis / Protocol Development, Study Execution, & Study Interpretation

• Consistent with membership of the Clinical Review Board Committee, responsible for critical review of synopses, protocols, IBs and relevant clinical documents relating to studies in assigned compounds.

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