- 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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clinical research coordinator
Found in: Careerbuilder One Red US C2 - 3 hours ago
Mlnneapolis heart institute foundation , MN, United StatesJob Summary · Do you find connecting with patients during challenging moments of their life rewarding? Are you a nurse passionate about cardiac care? Would you like to help further medical research? The Minneapolis Heart Institute Foundation (MHIF) is seeking an experienced Clini ...
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clinical research coordinator
Found in: Careerbuilder One Red US C2 - 7 hours ago
University of Minnesota, Twin Cities , MN, United StatesThis Clinical Research Coordinator position (Research Professional 2) will work on a study team completing cutting edge research using methods such as transcranial magnetic stimulation, magnetic resonance imaging, and drug interventions. The incumben Research Coordinator, Clinica ...
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vp clinical research
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Medtronic , MN, United StatesCareers That Change Lives · The Clinical Research and Medical Science (also know as Medical Affairs) leader serve in a leadership role for both the Neuromodulation and Pelvic Health businesses through contributions to the formulation of clinical strategy, organic and inorganic po ...
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clinical research coordinator
Found in: Careerbuilder One Red US C2 - 7 hours ago
University of Minnesota , MN, United StatesAbout the Job · This Clinical Research Coordinator position (Research Professional 2) will work on a study team completing cutting edge research using methods such as transcranial magnetic stimulation, magnetic resonance imaging, and drug interventions. The incumbent will coordin ...
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clinical researcher
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Hennepin County Medical Center Minneapolis, MN , USA, United StatesSUMMARY · The Addiction Medicine Division at Hennepin Healthcare seeks a full-time Clinical Researcher (MD or other doctoral level clinician) whose addiction-related research interests include health disparities and safety-net populations, integrated models of addiction care in g ...
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clinical research
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Kelly Services, Inc. St Paul, MN, USA, United States#x 9; Receiving and registering specimens Preparing and processing samples Conducting sample testing Arranging sample shipments Collecting data Requirements: AS/ BS in a health or science-related field 2 years of experience in laboratory work preferr Laboratory Technician, Clinic ...
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senior principal clinical research specialist – neuromodulation
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Medtronic Fridley, MN, USA, United StatesOversees, designs, plans, and develops clinical evaluation research studies for products that are under Clinical Investigation. Prepares and authors protocols and patient record forms. Conducts registered and non-registered clinical studies of produc Clinical, Research, Neuro, Sp ...
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delaware clinical research unit administrative assistant
Found in: Careerbuilder One Red US C2 - 7 hours ago
University of Minnesota, Twin Cities , MN, United StatesJOB DUTIES - Clinic Operations- 50%-The Delaware Clinical Research Unit (DCRU) administrative assistant serves as the first point of contact for study participants, visitors and researchers. - Ensure consistent coverage for the DCRU reception desk du Clinical Research, Administra ...
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delaware clinical research unit administrative assistant
Found in: Careerbuilder One Red US C2 - 7 hours ago
University of Minnesota , MN, United StatesAbout the Job · ESSENTIAL FUNCTIONS/JOB DUTIES · Clinic Operations- 50% · * The Delaware Clinical Research Unit (DCRU) administrative assistant serves as the first point of contact for study participants, visitors and researchers. · * Ensure consistent coverage for the DCRU recep ...
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part time clinical research assistant i
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Center for Veterans Research and Education , MN, United States Part time.50 FTE · Summary: · The Center for Veterans Research and Education (CVRE), whose mission is helping to support innovative research and education initiatives that improve the health and well-being of Veterans, is seeking a Research Assistant. The Research Assistant is responsible ...
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clinical research coordinator
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University of Minnesota Minneapolis, MN , USA, United StatesAbout the Job · Dr. Sabine Schmid in the Department of Psychiatry and Behavioral Sciences is seeking a part-time (4-6 hours per week) Clinical Research Coordinator (Researcher 1) passionate about advancing research on the treatment for major depressive disorder. This is an excell ...
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Clinical Research Lead
Found in: Lensa US 4 C2 - 2 days ago
University of Minnesota Twin Cities Minneapolis, United StatesThe Translational Neural Engineering Laboratory ) in the University of Minnesota Department of Psychiatry is seeking a clinical research lead to act as high-level orchestrator of multiple trials of advanced brain stimulation therapies for brain disorders. Our laboratory develops ...
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Clinical Research Lead
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University of Minnesota Minneapolis, United StatesApply for Job Job ID 359403 · Location Twin Cities · Job Family Research-Support · Full/Part Time Full-Time · Regular/Temporary Regular · Job Code 9354S2 · Employee Class Acad Prof and Admin · Add to Favorite Jobs Email this Job · About the Job · The Translational Neural Enginee ...
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Clinical Research Associate
Found in: One Red Cent US C2 - 2 days ago
University of Minnesota Minneapolis, United StatesApply for JobJob ID357345 · LocationTwin Cities · Job FamilyResearch-Support · Full/Part TimeFull-Time · Regular/TemporaryRegular · Job Code8352P3 · Employee ClassCivil Service · Add to Favorite JobsEmail this Job · About the Job · The Clinical Research Associate (CRA) advises a ...
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Clinical Research Coordinator
Found in: One Red Cent US C2 - 6 days ago
University of Minnesota Minneapolis, United StatesApply for JobJob ID360939 · LocationTwin Cities · Job FamilyResearch-Support · Full/Part TimeFull-Time · Regular/TemporaryRegular · Job Code8352P2 · Employee ClassCivil Service · Add to Favorite JobsEmail this Job · About the Job · This Clinical Research Coordinator position (Re ...
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clinical research coordinator
Found in: Careerbuilder One Red US C2 - 7 hours ago
University of Minnesota Minneapolis, MN , USA, United StatesAbout the Job · The primary purpose of the Clinical Research Coordinator (Research Professional 1) position includes: conducting assessments with research participants following IRB-approved protocols within the Research in Mechanisms of Addiction (RIMA) laboratory, and under the ...
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Clinical Research Coordinator
Found in: ZipRecruiter Test10S US C2 - 1 day ago
Minneapolis Heart Institute Foundation Minneapolis, United StatesJob Description · Job DescriptionJob Summary · Do you find connecting with patients during challenging moments of their life rewarding? Are you a nurse passionate about cardiac care? Would you like to help further medical research? The Minneapolis Heart Institute Foundation (MHIF ...
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Clinical Research Coordinator
Found in: One Red Cent US C2 - 2 days ago
University of Minnesota Minneapolis, United StatesApply for JobJob ID360729 · LocationTwin Cities · Job FamilyResearch-Support · Full/Part TimeFull-Time · Regular/TemporaryRegular · Job Code8352P1 · Employee ClassCivil Service · Add to Favorite JobsEmail this Job · About the Job · The primary purpose of the Clinical Research Co ...
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Clinical Research Associate
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Inspire Medical Systems I Minneapolis, United StatesJob Description · Job DescriptionABOUT INSPIRE MEDICAL SYSTEMS · Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical ...
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Clinical Research Scientist
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Anteris Tech Osseo, United StatesJob Description · Job DescriptionSalary: · Anteris is a structural heart company delivering clinically superior solutions that help healthcare professionals create life-changing outcomes for patients. We are currently developing the world's most durable heart valve. We are a med ...
VP Clinical Research - Mounds View, United States - Medtronic
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