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    VP Clinical Research - Mounds View, United States - Medtronic

    Medtronic
    Medtronic Mounds View, United States

    Found in: Talent US C2 - 4 days ago

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    Description
    Careers that Change Lives The Clinical Research and Medical Science (also know as Medical Affairs) leader serve in a leadership role within the OU through contributions to the formulation of clinical strategy, organic and inorganic portfolio development, marketing efforts, business development in relationships to clinical evidence development and dissemination.The role reports to the OU President and is a key member of the Leadership team.

    A Day in the Life
  • Provides integrated, strategic clinical research & medical science input to the OU Leadership Team.
  • The Clinical Leader is accountable for both Clinical Research and Medical Science, which operates with a strategic focus and input on on pre-clinical, clinical and economic evidence requirements for global market access on therapies and products solutions.
  • Clinical Leader leads the development and implementation of the medical science strategies and tactics that define the value proposition of the OU portfolio, and ultimately enables global market access.The leader will guide the strategy, planning and implementation of Clinical Research and Medical Science activities to ensure clinical relevancy and alignment to the OU priorities.
  • The Clinical Leader will have responsibility for Clinical Research and Medical Science resource allocation (people, capital)to meet and exceed the OUs annual and strategic plan goals, budget and spending.
  • Develop and oversees the implementation of Clinical Research and Medical Science strategies that enablethe OU to meet and exceed its goals, in alignment with cross-functional teams, including in the areas of Pre-Clinical and Clinical Research (CR), Healthcare Economics, Policy and Reimbursement (HEP&R) and Professional Affairs/Clinical Education (PACE).
  • The Clinical Leader will provide integrated, strategic clinical research & medical science input to the OU Leadership Team and serve as a clinical resource for navigating through the complexities of the regulatory approval process and post-market surveillance, e.g. well-versed in the requirements of the European Medical Device Directive and US FDA PMA and 510(k) processes
  • Maintains and communicates a deep understanding of the science behind the OU portfolio and develops competitive intelligence in our product space.
  • Ensures effective objective value propositions are developed and articulated for OU to stakeholders (patients, health care providers, payers, government agencies, health technology assessment organizations, public) through appropriate channels.
  • Establish a robust set of operating mechanisms to ensure collaboration within and outside of department, alignment of the shared services under the OU and execution to strategies and operating plans
    • Must Have: Minimum Requirements

  • Bachelors degree required
  • Minimum 15 years prior relevant experience; with Masters or other advanced degree, minimum 13 years prior relevant experience, minimum of 13 years of managerial experience
  • At minimum, 7 years' experience in the medical device, pharmaceutical, biotechnology or diagnostics industry
  • Experience in clinical research and regulatory affairs, specially related to the launch of high complex technology in US and OUS.
  • Experience in leading multiple functions (e.g., clinical healthcare policy & reimbursementetc.) and providing corporate and/or global level.
    • Nice to Have
  • An Advanced scientific degree (MS, PhD, MD, PharmD).
  • Assess and build new capabilities in response to changing external environment and OU needs
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