Senior Manager, Global Evidence & Outcomes

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Job Description

OBJECTIVES: 

Global Evidence and Outcomes (GEO) contributes to the successful development and commercialization of new and innovative therapies. This role executes GEO strategies through the design, conduct, and analyses of real-world evidence (observational) studies including epidemiological and outcomes research studies, development of predictive models, and/or contributes to the selection, development, and validation of clinical outcomes assessment (COA) endpoints for inclusion in clinical development and evidence generation programs.

Key position objectives are to:

• Contribute to the design, conduct and analyses of real-world evidence studies including epidemiological and outcomes research studies to support evidentiary needs from various 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.

• Contribute to the selection, development, and validation 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, and scientific reports.

• Collaborate and align internally with the GEO product lead to meet product needs.

• Communicate scientific findings to internal and external audiences as effectively as possible.

ACCOUNTABILITIES: 

• Works with a multidisciplinary, matrixed organization to execute and contribute to the design of real-world evidence studies and/or COA endpoint strategy/plan for one or more therapies in an assigned therapeutic area in collaboration with GEO product lead.

• Effectively manages external research partners to ensure projects are scientifically rigorous.

• Performs, as appropriate, relevant research activities which may include, but not limited to:

  • RFP development, protocol design, analytic plan, conduct, analyses 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, and predictive models/algorithms.

  • 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 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.

• Familiarity with software for management and analysis of data.

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

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

• Develops scientific reports reflecting ongoing or completed work.

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

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: 

• Combination of academic training and practical experience in observational research and/or COAs is required.  This may consist of:Master’s degree 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, and 3 years of 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 is desirable.

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

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

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

TRAVEL REQUIREMENTS:

Time commitment expected for travel is approximately 10 - 20 % domestic and international.

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:

Massachusetts - Virtual

U.S. Base Salary Range:

$137,000.00 - $215,270.00

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

Massachusetts - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

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