Director, Global Evidence & Outcomes

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OBJECTIVES:

Global Evidence and Outcomes (GEO) contributes to the successful development and commercialization of new and innovative therapies. Assigned to one or more global product(s), or as the lead for a disease area within GEO, this role informs and contributes to product strategies, clinical development plans and leads the development and execution of integrated evidence generation plans and component research studies (real world evidence and clinical outcomes assessment [COA] studies) for Takeda products to meet evidentiary needs from patients, healthcare providers, regulators, payers and other decision makers.

Key position objectives are to:

• Contribute to product strategy through membership on matrix teams and through interactions with cross-functional partners.
• Provide real-world evidence and patient-centered value leadership and consultative expertise for Takeda product(s) under responsibility from early development through launch and commercialization.
• Lead the integrated evidence generation sub team for products under development and develop the integrated evidence generation plan. This is a cross-functional team with global, regional and local members from R&D and commercial.
• Lead the development, execution, and communication of real-world evidence and COA strategies to support regulatory submissions, product labeling, access and commercialization.
• Communicate findings from these studies to relevant internal and external audiences as effectively as possible.
• May manage a small team depending on size of global programs/disease areas.

ACCOUNTABILITIES:

• Work with a multidisciplinary, matrixed organization, to ensure product priorities and strategies are aligned to meet evidentiary requirements/needs and support compelling product value propositions.
• Collaborate and partner with product teams/sub teams to inform program strategy and plans and to prepare for internal governance reviews/decisions.
• Assess and identify value evidence requirements/needs from internal and external stakeholders (patients, healthcare providers, regulators, HTAs/payers, and other decision makers) from early development through launch and commercialization of Takeda products under responsibility.
• Lead the integrated evidence generation sub team for products under development, and working with global, regional and local cross-functional colleagues lead the development of the integrated evidence generation plan. Ensure local evidence needs are met in line with product strategy.
• Lead, develop and execute successful GEO strategies and plans to support evidence needs as defined in the integrated evidence generation plan, clinical development plans and/or regulatory strategies including, but not limited to:
  Real-world evidence studies such as systematic literature reviews and meta-analyses, indirect treatment comparisons, observational research using existing data and/or collecting new data, development of synthetic control arms that include pre-existing data to support clinical development programs, and predictive models/algorithms.
• Ensure scientifically robust evidence generation activities are integrated into the development program evidence generation plans.
• Effectively manage external research partners to ensure projects are scientifically rigorous, medically relevant and address business needs as well as the needs of patients, health care providers and payers.
• Provide input into clinical development plans, regulatory documents with accuracy and scientific integrity as well as into commercial and access/reimbursement activities and documents.
• Prepare and/or review clinical and outcomes research protocols, statistical analysis plans (SAPs), and reports reflecting ongoing or completed work.
• Effectively communicates study findings to internal and external audiences, and as…