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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 a Director, Patient-Centered Outcomes in Cambridge, MA, where you will be responsible for 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. You will ensure these reflect the COA needs from key stakeholders, including regulators, payers, healthcare professionals and patients.

As part of the Global Evidence and Outcomes (GEO) team, you will report to the Head, Global Evidence & Outcomes, and focus on documenting the patient value of Takeda's new medicines to contribute to the successful development and commercialization of new, innovative therapies across the Plasma Derived Therapies portfolio through:

• Analysis of unmet clinical need and potential therapeutic preferences.

• 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.

• Subject matter expertise in the areas of eCOA operationalization/implementation and other technologies.

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.

• 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.

• Support electronic implementation of COAs in clinical trials/other studies including conditions of use, coordination with other teams of eCOA vendors/ensuring eCOA operationalization/eCOA study requirements are implemented appropriately

• 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.

• 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.

Minimum Requirements/Qualifications:

• Combination of academic training and practical experience 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 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 reguired.

• 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.

• Significant experience in eCOAs, research technology or eClinical field is required.

• 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.

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.

For Location:

Boston, MA

U.S. Base Salary Range:

$169,400.00 - $266,200.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time