Associate Director of Global Outcomes Research

Cambridge, MA

Posted: 08/22/2018 Employment Type: Contract Industry: ERT Job Number: 227174
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. 


ACCOUNTABILITIES: 

• 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. 

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