Associate Director, Clinical Outcomes Assessment, Global Evidence & Outcomes (Remote)

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Job Description

Objectives: 

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 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. 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.

Accountabilities: 

• 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 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

• Collaborate and partner with key internal stakeholder colleagues to ensure priorities and strategies are aligned.

• Perform relevant research activities that may include, but not be limited to: 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.

Qualifications: 

• Combination of academic training and practical experience (oncology experience preferred) in outcomes research is required.  This may be consist of: 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 5+ years practical experience. Masters degree in a related discipline (as noted above), plus 7+ years practical experience. 

• Practical experience in performing outcomes research required, preferably in different geographic regions and interacting with regulator and/or HTA/payer policy-makers

• A minimum of 3 years of Patient Reported Outcomes experience is required.

• Demonstrated experience in interpreting statistical analysis and communicating 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 expected.

• Ability to work collaboratively and effectively in a multicultural and cross functional team environment.

• Demonstrated expertise in patient-reported outcomes/health-related quality of life assessment is highly desirable. 

Travel: Time commitment expected for travel is approximately 10 - 25%.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

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EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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