This position functions within Takeda s Global Outcomes Research (GOR) team, which contributes to the successful development and commercialization of new and innovative therapies. GOER conducts its work in several therapeutic areas, and as part of a global company, addresses needs worldwide.
As a senior member of the GOR team, this person will provide leadership and expertise to develop and implement outcomes and epidemiology research strategies. These strategies will be comprised of evidence generation initiatives, specifically studies that identify clinical, economic, and patient-centered unmet needs, as well as the comparative clinical, economic, and patient-centered value that Takeda s medicines provide in addressing those needs.
In this context, the purpose of this position is to provide global epidemiology and outcomes research leadership for assigned therapeutic and functional areas. Key position objectives are:
- To provide outcomes and epidemiology research support for Takeda products from early development through launch and commercialization.
- To collaborate and align internally with other Takeda teams within a multi-disciplinary framework to meet product needs.
- To lead the development and execution of outcomes and epidemiology research strategies to elucidate unmet clinical, economic and patient-centered needs and product value.
- To lead the periodic revision and updating of outcomes and epidemiology research strategies in light of newly available knowledge.
- To communicate these outcomes and epidemiology strategies, and resulting findings, to relevant internal and external audiences as effectively as possible.
- Work within a multidisciplinary, matrixed organization to lead development and creation of successful outcomes and epidemiology research strategies for assigned therapeutic area(s).
- Ensure functional area(s) of expertise supports multiple therapeutic areas.
- Lead research portfolio that includes the design, implementation and communication of results of outcomes and epidemiology studies that achieve product-specific objectives.
- Represent the outcomes and epidemiology research function on corporate cross-functional teams related to product development and commercialization.
- Collaborate and partner with key internal stakeholder colleagues and external key opinion leaders to ensure priorities and strategies are aligned.
- Oversee, and ensure high quality of, relevant research activities which may include, but not be limited to:
- Targeted or comprehensive systematic literature reviews;
- Longitudinal prospective observational or randomized clinical trials evaluating clinical, patient-centered, and/or economic endpoints;
- Longitudinal retrospective studies of existing databases to assess patient characteristics, treatment patterns, and associated clinical, economic and/or patient-reported outcomes;
- Retrospective or prospective evaluations of disease natural history and treatment patterns, including drug utilization and adherence;
- Cross-sectional surveys of patients, caregivers, health care providers/practitioners, and/or payers/health technology assessment authorities;
- Assessments exploring burden of illness and/or comparative effectiveness.
- Development and validation of PRO and HRQoL instruments.
- Review and ensure the quality of outcomes and epidemiology research protocols, statistical analysis plans (SAPs),and reports.
- Review and publish scientific reports reflecting ongoing or completed work.
- Align with internal stakeholders to meet the outcome and epidemiology research needs of local operating companies.
- Communicate with relevant internal and external audiences, which may include regulators, health care providers/practitioners, HTA authorities/payers, patients and others.
- Ensure findings are communicated effectively, and as appropriate in conference presentations, publications, dossiers and other means.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Combination of academic training and practical experience in outcomes research and epidemiology 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 twelve years of practical experience
- Clinical degree (e.g., in medicine, pharmacy, nursing) and a masters degree in a related discipline (as noted above), plus ten years of practical experience
- Practical experience is defined as performing epidemiology and outcomes research, in any setting, including life sciences company, research organization, academic institution or governmental agency, is required.
- Expert knowledge and experience in management of epidemiology and outcomes research in the multi-disciplinary drug development and commercialization environment and process (involving multiple stakeholders) is expected.
- Demonstrated expertise in outcomes research (such as, but not limited to, retrospective or prospective observational studies, patient-reported outcomes/health-related quality of life assessment, clinical-economic modeling and analysis, /meta-analysis) is required.
- Knowledge of health economics is highly desirable.
- Demonstrated experience in conducting or interpreting statistical analysis is required.
- Strong leadership capability with proven skills in team building, and motivating and developing people, is expected.
- Experience in leading outcomes and epidemiology research in different geographic regions is highly desirable.
- Proven ability to work collaboratively and lead effectively in a multicultural and cross functional team environment is expected.
- Broad experience in collaborating with research partners and in managing multiple tasks and complex projects is expected.
- Demonstrated ability to communicate scientific evidence, with strong written and verbal presentation skills, is required.
- Record of high-quality, peer-reviewed epidemiology and/or outcomes research publications is required.
- Takeda is a global company with corporate headquarters in Japan and with Research & Development (R&D) headquarters in Cambridge, Massachusetts, USA.
- Travel to meetings (sometimes requiring overnight stays) involving Takeda colleagues, research partners, and/or external stakeholders is a requirement of the position.
- Some international travel may be required.
- Time commitment expected for travel is approximately 20 - 30 %.
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