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This position functions within Global Outcomes Research (GOR) team, which contributes to the successful development and commercialization of new, innovative therapies. Focuses and organizes itself into teams focused on neurosciences, gastroenterology and oncology, the purpose of this position is to provide global outcomes research support for one of these therapeutic areas.
As a member of the GOR team assigned to one or more global program teams, this person will inform and contribute to program strategies with comprehensive evidence generation plans and component research studies that identify clinical, economic, and patient-centered unmet needs, and the comparative clinical, economic, and patient-centered value that medicines provide in addressing those needs. Position objectives are:
• To provide outcomes research, including epidemiology, support and consultative expertise for products from early development through launch and commercialization.
• To collaborate and align internally with other R&D and Business Unit 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 regulators, HTA/payers, health care providers and patients.
• To design, execute and communicate results of appropriate tactical activities supporting those plans, including observational and epidemiologic research as well as experimental trials.
• To communicate findings from these studies to relevant internal and external audiences as effectively as possible.
• Work within a multidisciplinary, matrixed organization to develop and execute successful GOR strategies and plans for one or more therapies in an assigned therapeutic area.
• Using epidemiologic and observational research expertise, design, implement and communicate results of outcomes research studies, including epidemiologic research, that help achieve product-specific objectives.
• Represent the GOR function and provide strategic input on corporate cross-functional teams related to product development and commercialization to enable and support informed decision making.
• 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:
o 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;
o Longitudinal retrospective studies of existing databases to assess patient characteristics, treatment patterns, and associated clinical, economic and/or patient-reported outcomes;
o Retrospective or prospective evaluations of disease natural history and treatment patterns, including drug utilization and adherence;
o Cross-sectional surveys of patients, caregivers, health care providers/practitioners, and/or payers/health technology assessment authorities;
o Clinical-economic models and assessments exploring burden of illness and/or comparative effectiveness.
o Targeted or comprehensive systematic literature reviews;
o Development and validation of PRO and HRQoL instruments.
• Prepare and/or review outcomes research protocols, statistical analysis plans (SAPs),and reports.
• Prepare, review, and publish scientific reports reflecting ongoing or completed work.
• Align with internal stakeholders to meet the outcomes 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.
SCOPE OF SUPERVISION:
SUPERVISED NUMBER OF EMPLOYEES
Managers/Supervisors 0 0
Exempt/Professional/Technical 0-2 0-2
Non-Exempt 0-2 0-2
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
• Experience in one or more disciplines within outcomes research in relevant therapeutic areas is preferred. Demonstrated experience in epidemiology and observational studies is highly desirable.
• Combination of academic training and practical experience in outcomes research is required. This may be consist of:
o 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
o Clinical degree (e.g., in medicine, pharmacy, nursing) and a masters degree in a related discipline (as noted above), plus five years practical experience
o 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.
• Ability to understand regulatory and HTA/payer challenges for products; and to critically review data and assimilate strategies that take such environments into consideration is required.
• 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.
• Excellent qualitative and quantitative epidemiological skills, including study design analysis and interpretation of data from observational research.
• 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.
• Experience interacting with regulator and/or HTA/payer policy-makers is highly desirable.
• Record of high-quality, peer-reviewed outcomes research publications is preferred.
No licenses/certifications are required in this position.
is a global company with corporate headquarters in Japan, and with global research and development activities run from Cambridge, Massachusetts, USA.
Travel to meetings (sometimes requiring overnight stays) involving 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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