Associate Director – Global Evidence & Outcomes

Associate Director – Global Evidence & Outcomes

Requirements

• A combination of academic training and practical experience in outcomes research is required. This may consist of: Doctoral degree (e.g., PhD, ScD, DrPH, MD, PharmD) in a relevant discipline such as, but not limited to, medicine, pharmacy, health services research, health outcomes research, economics, epidemiology, pharmacy administration, public health, economics, statistics or decision sciences, plus 5+ years practical experience. Master’s degree in a related discipline (as noted above) plus 7+ years practical experience.
• Practical experience (number of years as noted above) in conducting research in epidemiology, health economics and outcomes, pharmacoepidemiology, Pharmacoeconomics, and/or computational biology, in any setting (including life sciences, contract research organizations, academia or governmental agency) is required.
• Strong technical expertise in the design, conduct, and interpretation of observational studies as well as the scientific communication of study findings.
• 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.

Responsibilities

• Lead the design, conduct, analyses, interpretation, and communication of real-world evidence studies including epidemiological and outcomes research studies to support evidentiary needs for internal and external stakeholders for Takeda products from early development through launch and commercialization in alignment with product evidence generation plans.
• Inform and collaborate on 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.
• Provide expertise and guidance on observational research including the evaluation and use of clinical/molecular/genetic data sets to analysts and other cross-functional team members.
• Collaborate and partner with other key internal 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 cross-functional setting.
• Communicate scientific findings to internal and external audiences.
• 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 within a multidisciplinary, matrixed organization to lead the design, conduct, analyses, and interpretation of real-world evidence studies, 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 – including 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, execution, interpretation, and communication of literature reviews (targeted, systematic etc.), meta-analyses, and indirect treatment comparisons; development of synthetic control arms to support clinical development programs and regulatory/HTA submissions. Design, execution, interpretation, and communication of real-world evidence studies such as observational research using existing data and/or collecting new data, development of synthetic control arms and predictive models/algorithms to support clinical development programs. Assessing and documenting population estimates. Execution of COA strategy/plan for a specific product(s). This includes conducting qualitative and quantitative research to inform development of conceptual disease-models; designing and executing studies in whole or in part to generate evidence on the validity of COA endpoints and developing COA evidence dossiers for regulatory submissions; conducting analyses of PRO data from clinical trials to support value messages and labelling claims.
• 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 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, peer-reviewed publications 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.

Preferred Qualifications

• Records of high-quality, peer-reviewed publication is preferred.