Associate Director, Patient-Centered Outcomes, Global Evidence and Outcomes
TakedaAbout the role
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Job Description
About the role:
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
Join Takeda as an Associate Director, Patient-Centered Outcomes, Global Evidence and Outcomes where you will be recognized as an expert within your business or function, possess comprehensive expertise in your discipline and broad knowledge across related areas. Excel at anticipating internal/external challenges, recommending improvements, and providing leadership and consultative expertise for a specific business, region or function. This role involves shaping company policies, solving unique, far-reaching problems affecting operations, disciplines, or other business units/functional areas/regions. Frequently interacts with equivalent-level managers and customer representatives, conducting briefings and technical meetings. Operating independently, you provide guidance in the most complex situations, lead functional teams or projects, and serve as a best practice/quality resource.
You will also participate in analysis of unmet clinical need and potential therapeutic preferences. Development of Clinical Outcome Assessment (COA) endpoint(s) as appropriate for clinical development programs and inclusion of COA endpoint strategy in all major deliverables such as clinical development plans, study protocols, strategy slide decks, statistical analysis plans, briefing packages, clinical study reports, and regulatory labelling interactions. Ensure these reflect the COA needs from key stakeholders, including regulators, payers, healthcare professionals and patients. Collaboration and alignment internally with the GEO asset lead (if applicable) and other Takeda R&D and Business Unit teams within a multi-disciplinary framework to meet product needs. Development of evidence for COA measurement strategies for development of post-authorization and commercial research activities supporting patient-centered needs and product value to regulators, HTA/payers, health care providers and patients. Development and implementation of COA-based support tools for patients and healthcare professionals in routine clinical practice using digital technologies.
As part of the Global Evidence & Outcomes, you will report to the Executive Director, Global Evidence & Outcomes.
How you will contribute:
- Conduct qualitative and quantitative research to inform development on conceptual disease-models.
- Develop, assess and interpret COAs, including Patient-Reported Outcomes (PROs), Observer-Reported Outcomes (ObsROs) and Clinician-Reported Outcomes (ClinROs), and performance outcome (PerfO) measures to derive clinical benefit during the clinical development and commercialization of new molecules, including development and validation of PRO and health-related quality of life instruments.
- Provide strategic input on corporate cross-functional teams related to product development and commercialization to enable and support informed decision making.
- Generate patient insights about disease and treatment and inform COA measurement strategies to support development, post-authorization and commercial research activities across the lifecycle of drug development.
- Contribute to the strategy development and generate evidence for COA-based support tools for patients and healthcare professionals in routine clinical practice using digital technologies.
- Work within a
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