Associate Director of Global Outcomes Research
• 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.