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Extensive experience in medical affairs/post-approval area and execution of project user requirements, system design, validation plans, operational and performance protocols, research, and development of applications and toolkits for end-users.
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Contributes to overall Program strategy and interacts with Regulatory, Clinical Pharmacology, Research, Non Clinical functions, and more, to create and deliver integrated clinical development plans, working alongside the Global Strategy Head for the Program.
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Identify and maintain successful research relationships with HEOR key opinion leaders. Develop and implement global and regional strategies and programs to inform, support and strengthen commercialization activities, clinical development, marketing, and market access.
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The Director of Statistical Programming Medical Affairs provides leadership to the group in Medical Affairs, including Health Economics and Outcomes Research (HEOR). We need you to regularly meet with the Statistical Programming management team for close collaboration with the clinical development statistical programming team to evaluate and develop solutions for project resourcing, quality, timelines, and budget.
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This is to ensure the distribution of clinical and scientific information regarding in-development or commercialized Regeneron products in a timely, ethical and customer-focused manner.
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As a Director in Pharmacometrics (PPK/PD, QP, or CP as appropriate), this individual is is accountable for the delivery of support for one or more research & development programs, within their pharmacometric discipline.
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Supports clinical research activities throughout the life cycle (phase 1-4), mainly focusing on identification of pre-clinical, clinical and post-marketing study investigators/ specialists and sites.
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Possesses proficient scientific expertise to propose, design, and execute clinical research and development studies for early and/or late stage assets; able to conceive and communicate strategy proposals well-grounded in supporting literature.
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