Associate Director Global Evidence and Outcomes

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director, Global Evidence and Outcomes in our Cambridge, MA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

POSITION 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 the value of real-world evidence (observational) studies including epidemiological and outcomes research studies for the development of therapies, and/or leading the selection of endpoints for inclusion in both hypothesis testing and generating analysis plans in translational medicine. A key component is to contribute to the evidence generation programs.

• Lead the design, conduct, analyses, interpretation, and communication of real-world evidence studies including complex epidemiological and outcomes research studies including genetic/ genomic data 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, evaluation, and interpretation of clinical endpoint(s) as appropriate for asset development programs and other evidence generation programs for relevant   disease areas. This may include developing statistical analysis plans, scientific reports, briefing packages, clinical study reports, and regulatory labelling interactions.
• Provide expertise and guidance on observational research in the evaluation and use of data sets with both molecular/ genetic and clinical data to analysts and other cross-functional team members.
• Collaborate and partner internally with the GEO product lead and other functions to ensure relevant GEO studies are aligned with disease and asset strategy, as well as congruent with evidence generation plans within a multi-disciplinary Takeda framework to meet study needs.
• Communicate scientific findings to internal and external audiences as effectively as possible.

POSITION 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 translational medicine, for one or more therapies in an assigned therapeutic area (e.g.