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 a Director, Patient-Centered Outcomes, Global Evidence and Outcomes in Cambridge, MA, where you will be responsible for leading the development and execution of integrated evidence generation plans and component research studies for Takeda products. This role ensures that the evidence generated meets the needs of patients, healthcare providers, regulators, payers, and other decision-makers, contributing to the successful development and commercialization of innovative therapies.

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 portfolio through: 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 and ensuring these reflect the COA needs from key stakeholders, including regulators, payers, healthcare professionals and patients. Your responsibilities also include conducting high-level briefings and technical meetings, interacting with managers of equivalent status, and crafting corporate and organizational policies. You will provide strategic direction and oversight to managers across various functional areas, prioritizing the successful execution of major initiatives and ensuring that budgets, schedules, and performance standards are both realistically established and achieved. Your role focuses on strategic impact rather than day-to-day operational involvement.

How you will contribute:

• Provide expert advice on PRO measurement needs to cross-functional molecule 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. 
• 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.  
• 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  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. 
• Collaborate and partner with key internal stakeholder colleagues to ensure priorities and strategies are aligned.  
• Design, execution, and analysis in whole or in part of longitudinal prospective observational or randomized clinical trials evaluating clinical, and/or patient-centered endpoints; Targeted or comprehensive systematic literature reviews. 
• Ensure findings are communicated effectively, and as appropriate in conference presentations, publications, regulatory and reimbursement dossiers and other communication mechanisms.  

Minimum Requirements/Qualifications:

• Doctoral degree (e.g., Ph.D., Sc.D. or Dr.P.H.) in a relevant discipline such as, but not limited to, health services research, health outcomes research, epidemiology, pharmacy administration, public health, economics, statistics or decision sciences, plus 8+ years practical experience OR Masters degree in a related discipline (as noted above), plus 10+ years practical experience.   
• Practical experience (number of years as noted above) in performing outcomes research, in any setting, including life sciences company, research organization, academic institution or governmental agency, is required.  
• A minimum of 5 years of Patient Reported Outcomes experience is required. 
• Demonstrated experience in interpreting statistical analysis is required. Ability to communicate scientific evidence, with strong written and verbal presentation skills, is required. 
• Working knowledge of Patient Focused Drug Development (PFDD) Guidance documents and other relevant guidance documents and best practices is required. 
• Ability to understand regulatory and HTA/payer challenges for Takeda products; and to critically review data and assimilate strategies that take such environments into consideration is required. 
• Familiarity with the role and importance of outcomes research in the multi-disciplinary drug development and commercialization environment and process (involving multiple stakeholders) is required. 
• Experience should include the conduct of outcomes research studies, and the communication of study findings to internal and external audiences. 
• Expertise and experience with the development, psychometric evaluation and selection of PRO instruments used in clinical studies is expected.  
• Must be capable of leading teams, influencing teams, and driving decisions; must also be able to work effectively as a member of different teams.  
• Experience with the drug development process in the pharmaceutical industry is strongly preferred. Regulatory understanding and experience in negotiating PRO label claims is strongly preferred. Experience with ePRO is strongly preferred.  
• Ability to work collaboratively and effectively in a multicultural and cross functional team environment. 
• Experience managing budgets is expected. 
• Demonstrated expertise in patient-reported outcomes/health-related quality of life assessment is highly desirable.   
• Experience in conducting outcomes research in different geographic regions and interacting with regulator and/or HTA/payer policy-makers is highly desirable. 

More About Us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as “remote” by Takeda’s Hybrid and Remote Work policy.