This position functions within Takeda s Global Outcomes Research (GOR) team, which contributes to the successful development and commercialization of new and innovative therapies. As a member of the GOR team, this person will engage in global outcomes research 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. As Takeda is especially interested in developing its gastrointestinal (GI) therapeutic area, notably related to Ulcerative Colitis (UC) and Crohn s disease (CD), the purpose of this position is to provide global outcomes research support for this therapeutic area. Key position objectives are:
- To provide outcomes research support and consultative expertise for Takeda GI products from early development through launch and commercialization across the product lifecycle.
- To collaborate and align internally with other Takeda teams within a multi-disciplinary framework to meet product needs.
- To contribute to the development and execution of plans to elucidate unmet clinical, economic and patient-centered needs and product value.
- To design, execute and communicate results of appropriate tactical activities supporting those plans.
- To communicate findings from these outcomes studies to relevant internal and external audiences as effectively as possible.
- Work within a multidisciplinary, matrixed organization to develop and execute successful outcomes and epidemiology research strategies for one or more therapies in an assigned therapeutic area.
- Design, implement and communicate results of outcomes and epidemiology research studies that help 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 to ensure priorities and strategies are aligned.
- Perform, as appropriate, relevant research activities which may include, but not be limited to:
- Targeted or comprehensive systematic literature reviews;
- Design, execution, and analysis in whole or in part of 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;
- Clinical-economic models and assessments exploring burden of illness and/or comparative effectiveness.
- Development and validation of PRO and HRQoL instruments.
- Prepare and/or review outcomes and epidemiology research protocols, statistical analysis plans (SAPs),and reports.
- Prepare, review, and publish scientific reports reflecting ongoing or completed work.
- Communicate findings from outcomes and epidemiology studies to 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, EXPERIENCE, KNOWLEDGE AND SKILLS:
- Experience in outcomes research in the GI therapeutic area, especially in UC & CD, is preferred. Demonstrated experience in GI-related observational studies is highly desirable.
- 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 five years practical experience
- Clinical degree (e.g., in medicine, pharmacy, nursing) and a masters degree in a related discipline (as noted above), plus five years practical experience
- Masters degree in a related discipline (as noted above), plus eight years practical experience.
- Practical experience (number of years as noted above) in performing outcomes research, in any setting, including life sciences company, research organization, academic institution or governmental agency, is required.
- Experience should include the conduct of outcomes research studies, and the communication of study findings to internal and external audiences.
- Familiarity with the role and importance of epidemiology and outcomes research in the multi-disciplinary drug development and commercialization environment and process (involving multiple stakeholders) is expected.
- Demonstrated expertise in at least one area of 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, literature synthesis/meta-analysis) is highly desireable.
- Knowledge of health economics is desirable.
- Demonstrated experience in conducting or interpreting statistical analysis is useful.
- Experience in conducting outcomes research in different geographic regions is desirable.
- Ability to work collaboratively and 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 very desirable.
- Ability to communicate scientific evidence, with strong written and verbal presentation skills, is required.
- Record of high-quality, peer-reviewed outcomes research publications is preferred.
- Takeda is a global company with corporate headquarters in Japan and with Pharmaceutical Development Division (PDD) headquarters in Deerfield, Illinois, 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 10 - 25 %.
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