Associate Director Global Evidence and Outcomes

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director, Global Evidence and Outcomes in our Cambridge, MA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

POSITION OBJECTIVES:

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 the value of real-world evidence (observational) studies including epidemiological and outcomes research studies for the development of therapies, and/or leading the selection of endpoints for inclusion in both hypothesis testing and generating analysis plans in translational medicine. A key component is to contribute to the evidence generation programs.

• Lead the design, conduct, analyses, interpretation, and communication of real-world evidence studies including complex epidemiological and outcomes research studies including genetic/ genomic data 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.
• Inform and collaborate in the design and conduct of observational studies to support clinical development of Takeda products, including development of synthetic controls.
• Lead the selection, development, evaluation, and interpretation of clinical endpoint(s) as appropriate for asset development programs and other evidence generation programs for relevant   disease areas. This may include developing statistical analysis plans, scientific reports, briefing packages, clinical study reports, and regulatory labelling interactions.
• Provide expertise and guidance on observational research in the evaluation and use of data sets with both molecular/ genetic and clinical data to analysts and other cross-functional team members.
• Collaborate and partner internally with the GEO product lead and other functions to ensure relevant GEO studies are aligned with disease and asset strategy, as well as congruent with evidence generation plans within a multi-disciplinary Takeda framework to meet study needs.
• Communicate scientific findings to internal and external audiences as effectively as possible.

POSITION ACCOUNTABILITIES:

• 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 translational medicine, for one or more therapies in an assigned therapeutic area (e.g., works with GEO asset/ disease leads as an, integrated member of the global translational team 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. Assess and document population estimates including relevant subgroups. 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 analytical software for management and analysis of data.
• Follows best practices for data collection, conduct and reporting of real-world evidence and molecular 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.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

• 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, genetics 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 computational biology, 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, time to event modeling or molecular data 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 in the drug development setting
• 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 across functions with different levels of knowledge, is required.
• Record of high-quality, peer-reviewed publications is preferred.

TRAVEL REQUIREMENTS: Time commitment expected for travel is approximately 10 -30% domestic and international.

This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.

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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:

$153,600.00 - $241,340.00

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

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.