Associate Director Global Evidence and Outcomes

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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, Global Evidence and Outcomes where you will lead the design, conduct, analyses, interpretation and communication of real-world evidence studies including complex epidemiological and outcomes research studies to support evidentiary needs for internal and external stakeholders for Takeda products from early development through launch and commercialization across the product lifecycle in alignment with product evidence generation plans. You will inform and collaborate in the design and conduct of observational studies to support clinical development of Takeda products, including development of synthetic controls.

Global Evidence and Outcomes (GEO) contributes to the successful development and commercialization of new and innovative therapies. This role is responsible for the execution of GEO strategies through the design, implementation and communication of real-world evidence (observational) studies including epidemiological and outcomes research studies, development of predictive models, and/or leading the selection, development, and validation of clinical outcomes assessment (COA) endpoints for inclusion in clinical development and evidence generation programs. You will lead the selection, development, validation, and interpretation of COA endpoint(s) as appropriate for clinical development programs and other evidence generation programs for all COA endpoint strategy deliverables including COA development plans, study protocols, statistical analysis plans, scientific reports, briefing packages, clinical study reports, and regulatory labelling interactions.

You will also provide technical expertise and guidance on observational research and/or COAs and collaborate and partner internally with the GEO product lead and other functions to ensure GEO studies under responsibility are aligned with product strategy and evidence generation plans and with other Takeda teams within a multi-disciplinary framework to meet study needs. As part of the Global Evidence and Outcomes team, you will report to the Director, Global Evidence & Outcomes, Neuroscience.

How you will contribute: 

• Collaborates with GEO colleagues and key internal stakeholders to ensure priorities and strategies are aligned.

• Contributes to the development and lead the execution of plans addressing unmet evidentiary and patient-centered needs and product value to regulators, HTA/payers, health care providers and patients.

• Works with a multidisciplinary, matrixed organization to lead the design, conduct, analyses, and interpretation of real-world evidence studies and/or the COA endpoint strategy/plan for one or more therapies in an assigned therapeutic area. (e.g., works as a product lead and as a member of the GPT, integrated evidence generation sub teams, and/or other cross-functional teams/ sub-teams with manager supervision).

• Effectively manages external research partners to ensure projects are scientifically rigorous, medically relevant and address business needs as well as the needs of patients, health care providers and payers.

• Provides input into clinical development, regulatory, reimbursement documents.

• Performs/manages, as appropriate, relevant research activities which may include, but not limited to: Design, conduct, analyses, interpretation, and communication of real-world evidence studies such as systematic literature reviews and meta-analyses, indirect treatment comparisons, observational research using existing data and/or collecting new data, development of synthetic control arms that include pre-existing data to support clinical development programs and predictive models/algorithms. Develops and interprets COAs to derive clinical benefit during the clinical development and commercialization. Execution of COA endpoints strategy/plan for a specific product(s) such as conduct qualitative and quantitative research to inform development on conceptual disease-models, design and execute studies in whole or in part to generate evidence on the validity of COA endpoints and produce COA evidence dossiers for regulatory submissions.

• Prepares and/or reviews clinical and outcomes research protocols, statistical analysis plans (SAPs), and reports.

• Familiarity with software for management and analysis of data.

• Follows best practices for data collection, conduct and reporting of real-world evidence and COA studies.

• Compliance with all policies and regulations for quality and disclosure.

• Accountable for project(s) contract/budget management.

• Reviews and develops scientific reports reflecting ongoing or completed work.

• Effectively communicates scientific findings internally and externally in conference presentations, publication and other communication mechanisms.

• Networks with external researchers in the field in order to remain on top of best practices, new methodologies and enhance Takeda’s visibility in the area of real-world evidence and COAs.

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 5+ years practical experience. Masters degree in a related discipline (as noted above), plus 7+ years practical experience. 

• Practical experience (number of years as noted above) in performing epidemiology and outcomes research and/or COAs, in any setting, including life sciences company, research organization, academic institution or governmental agency, is required.

• Strong technical expertise required in design and conduct of observational studies, predictive modeling or COAs as well as the scientific communication of study findings.

• Demonstrated experience in conducting or interpreting statistical analysis is useful.

• Experience in conducting research in different geographic regions and interacting with regulators and/or HTA/payer, policy makers.

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

• Ability to work in a global environment, independently as well as in a team and to manage multiple projects to tight deadlines with strong orientation to detail.

• Ability to communicate scientific evidence, with strong written and verbal presentation skills, is required.

• Record of high-quality, peer-reviewed publications is preferred.

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 can be classified as "hybrid" or "remote" in accordance with Takeda's Hybrid and Remote Work policy.

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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U.S. Base Salary Range:

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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