Associate Director, Global Evidence and Outcomes

Role Summary

Associate Director, Global Evidence and Outcomes

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.

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.

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 COA endpoint strategy/plan for one or more therapies in an assigned therapeutic area.
• 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 relevant research activities including design, conduct, analyses, interpretation, and communication of real-world evidence studies; development of synthetic control arms; 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 specific products and produce COA evidence dossiers for regulatory submissions.
• Prepares and/or reviews clinical and outcomes research protocols, 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 to stayCurrent on best practices and enhance Takeda‚Äôs visibility in real-world evidence and COAs.

Qualifications

• Combination of academic training and practical experience in outcomes research is required. Doctoral degree (e.g., Ph.D., Sc.D. or Dr.P.H.) in a relevant discipline plus 5+ years practical experience, or a Master‚Äôs degree plus 7+ years practical experience.
• Practical experience in performing epidemiology and outcomes research and/or COAs in life sciences, research organizations, academia, or government.
• Strong technical expertise in design and conduct of observational studies, predictive modeling or COAs and scientific communication of findings.
• Experience in conducting or interpreting statistical analysis is useful.
• Experience in research across geographic regions and interacting with regulators and/or HTA/payer policy makers.
• Ability to work collaboratively in a multicultural, cross-functional team; ability to manage multiple projects to tight deadlines with attention to detail.
• Strong written and verbal presentation skills for scientific evidence.
• Record of high-quality, peer-reviewed publications is preferred.

Skills

• Outcomes research
• Observational study design
• COA development and validation
• Data management and analysis software
• Scientific communication
• Cross-functional collaboration

Education

• Doctoral degree (Ph.D., Sc.D., Dr.P.H.) in health services research, health outcomes research, epidemiology, pharmacoeconomics, public health, statistics or related fields, with 5+ years of practical experience; or Master‚Äôs degree with 7+ years of practical experience.

Additional Requirements

• Travel: 10-30% domestic and international.