Director, Clinical Outcomes Assessment, Global Evidence & Outcomes

Takeda

21h•Remote

About The Position

As part of the Global Evidence and Outcomes (GEO) team, this position is focused on documenting the patient value of Takeda's new medicines to contribute to the successful development and commercialization of new, innovative therapies across the oncology portfolio. This role involves developing Clinical Outcome Assessment (COA) endpoint(s) as appropriate for clinical development programs and ensuring COA endpoint strategy is integrated into major deliverables. The position requires providing expert advice on PRO measurement needs to cross-functional teams and collaborating internally with GEO asset leads and other Takeda R&D and Business Unit teams. The role is accountable for generating evidence for COA measurement strategies for post-authorization and commercial research activities, and for developing and implementing COA-based support tools for patients and healthcare professionals using digital technologies. The Director will represent the GEO function on corporate cross-functional teams, providing strategic input related to product development and commercialization. The role also involves generating patient insights and leading the development of COA measurement strategies across the drug development lifecycle, with consideration for global stakeholder needs. Additionally, the Director will lead strategy development and evidence generation for COA-based support tools and work within a multidisciplinary, matrixed organization to develop and execute successful Oncology COA endpoint strategies for multiple assets. This includes preparing and/or reviewing outcomes research protocols, statistical analysis plans (SAPs), and reports, with a specific focus on COAs, and ensuring findings are communicated effectively through conference presentations, publications, and regulatory/reimbursement dossiers.

Requirements

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.
Provide expert advice on PRO measurement needs to cross-functional teams to ensure included in comprehensive evidence generation plans and implemented appropriately.
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.
Accountable for the generation 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.
Represent the GEO function on corporate cross-functional teams, providing strategic input related to product development and commercialization to enable and support informed decision making.
Generate patient insights about disease and treatment, and lead the development of COA measurement strategies to support clinical development, post-authorization and commercial research activities across the lifecycle of drug development with consideration for global stakeholder needs.
Lead strategy development and evidence generation of COA-based support tools for patients and healthcare professionals in routine clinical practice using digital technologies.
Work within a multidisciplinary, matrixed organization to develop and execute successful Oncology COA endpoint strategies for multiple assets.
Prepare and/or review outcomes research protocols, statistical analysis plans (SAPs), and reports, with a specific focus on COAs.
Prepare, review, and publish scientific reports reflecting ongoing or completed work.
Ensure findings are communicated effectively, and as appropriate in conference presentations, publications, regulatory and reimbursement dossiers and other communication mechanisms.

Responsibilities

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.
Provide expert advice on PRO measurement needs to cross-functional teams to ensure included in comprehensive evidence generation plans and implemented appropriately.
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.
Accountable for the generation 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.
Represent the GEO function on corporate cross-functional teams, providing strategic input related to product development and commercialization to enable and support informed decision making.
Generate patient insights about disease and treatment, and lead the development of COA measurement strategies to support clinical development, post-authorization and commercial research activities across the lifecycle of drug development with consideration for global stakeholder needs.
Lead strategy development and evidence generation of COA-based support tools for patients and healthcare professionals in routine clinical practice using digital technologies.
Work within a multidisciplinary, matrixed organization to develop and execute successful Oncology COA endpoint strategies for multiple assets.
Prepare and/or review outcomes research protocols, statistical analysis plans (SAPs), and reports, with a specific focus on COAs.
Prepare, review, and publish scientific reports reflecting ongoing or completed work.
Ensure findings are communicated effectively, and as appropriate in conference presentations, publications, regulatory and reimbursement dossiers and other communication mechanisms.