Associate Director, Global Evidence and Outcomes

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Job Description

OBJECTIVES: 

Global Evidence and Outcomes (GEO) contributes to the successful development and commercialization of new and innovative therapies. This role is responsible for the execution of GEO strategies through the design, implementation and communication of real-world evidence (observational) studies including epidemiological and outcomes research studies, development of predictive models, and/or leading the selection, development, and validation of clinical outcomes assessment (COA) endpoints for inclusion in clinical development and evidence generation programs

Key position objectives are to:

• Lead the design, conduct, analyses, interpretation and communication of real-world evidence studies including complex epidemiological and outcomes research studies to support evidentiary needs for internal and external stakeholders for Takeda products from early development through launch and commercialization across the product lifecycle in alignment with product evidence generation plans.

• Inform and collaborate in the design and conduct of observational studies to support clinical development of Takeda products, including development of synthetic controls.

• Lead the selection, development, validation, and interpretation of COA endpoint(s) as appropriate for clinical development programs and other evidence generation programs for all COA endpoint strategy deliverables including COA development plans, study protocols, statistical analysis plans, scientific reports, briefing packages, clinical study reports, and regulatory labelling interactions.

• Provide technical expertise and guidance on observational research and/or COAs.

• Collaborate and partner internally with the GEO product lead and other functions to ensure GEO studies under responsibility are aligned with product strategy and evidence generation plans and with other Takeda teams within a multi-disciplinary framework to meet study needs.

• Communicate scientific findings to internal and external audiences as effectively as possible.

ACCOUNTABILITIES: 

• Collaborates with GEO colleagues and key internal stakeholders to ensure priorities and strategies are aligned.

• Contributes to the development and lead the execution of plans addressing unmet evidentiary and patient-centered needs and product value to regulators, HTA/payers, health care providers and patients.

• Works with a multidisciplinary, matrixed organization to lead the design, conduct, analyses, and interpretation of real-world evidence studies and/or the COA endpoint strategy/plan for one or more therapies in an assigned therapeutic area. (e.g., works as a product lead and as a member of the GPT, integrated evidence generation sub teams, and/or other cross-functional teams/ sub-teams with manager supervision)

• Effectively manages 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.

• Provides input into clinical development, regulatory, reimbursement documents.

• Performs/manages, as appropriate, relevant research activities which may include, but not limited to: Design, conduct, analyses, interpretation, and communication of 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. Develops and interprets COAs to derive clinical benefit during the clinical development and commercialization. Execution of COA endpoints strategy/plan for a specific product(s) such as conduct qualitative and quantitative research to inform development on conceptual disease-models, design and execute studies in whole or in part to generate evidence on the validity of COA endpoints and produce COA evidence dossiers for regulatory submissions.

• Prepares and/or reviews clinical and outcomes research protocols, statistical analysis plans (SAPs), and reports.

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