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.
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
Key position objectives are to:
- 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.
- 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, 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.
- Provide technical expertise and guidance on observational research and/or COAs.
- 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.
- Communicate scientific findings to internal and external audiences as effectively as possible.
- 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.
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, 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.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
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.