Associate Director, Global Evidence and Outcomes

Role Summary

Associate Director, Global Evidence and Outcomes

Responsibilities

• 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.

Qualifications

• Combination of academic training and practical experience in outcomes research is required. This may 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 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.

Skills

• Observational research design and conduct
• COA endpoint development and interpretation
• Statistical analysis and predictive modeling
• Scientific communication and dissemination
• Cross-functional collaboration
• Regulatory and health technology assessment interactions

Education

• Doctoral degree (Ph.D., Sc.D. or Dr.P.H.) in a relevant discipline with 5+ years practical experience; or Master‚Äôs degree with 7+ years practical experience.

Additional Requirements

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