- 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
-
Clinical Researcher
1 week ago
Hennepin County Medical Center Minneapolis, 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 ...
-
Medtronic, plc Fridley, 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 ...
-
Clinical Research
1 week ago
Kelly Services, Inc. Saint Paul, 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 ...
-
Clinical Research Coordinator
1 week ago
Mlnneapolis heart institute foundation Minneapolis, 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 ...
-
Clinical Research Coordinator
4 days ago
Mlnneapolis heart institute foundation Minneapolis, United StatesDo you find connecting with patients during challenging moments of their life rewarding? Are you a curious, continuous learner interested in cardiac care? Would you like to help further medical research? The Minneapolis Heart Institute Foundation (MHIF) currently has multiple ope ...
-
Clinical Research Coordinator
1 week ago
University of Minnesota Minneapolis, 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 ...
-
Director of Clinical Research
5 days ago
Kerecis LLC Minneapolis, United StatesJob Type · Full-time · Description · Summary · The Director of Clinical Affairs is responsible for all clinical aspects of medical device development projects at all stages of the product life cycle, for clinical affairs activities, and for special projects. This full-time role r ...
-
VP Clinical Research
1 week ago
Medtronic Minneapolis, 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 ...
-
Clinical Research Coordinator
1 week ago
University of Minnesota Minneapolis, 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 ...
-
Director of Clinical Research
1 day ago
Kerecis LLC Minneapolis, United StatesJob Description · Job DescriptionDescription:Summary · The Director of Clinical Affairs is responsible for all clinical aspects of medical device development projects at all stages of the product life cycle, for clinical affairs activities, and for special projects. This full-tim ...
-
Clinical Research Associate
1 week ago
Inspire Medical Systems, Inc. Golden Valley, United StatesABOUT 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 device, designed to reduce OSA se ...
-
Clinical Research Associate
2 days ago
University of Minnesota Minneapolis, United StatesJob ID · Location Twin Cities · Job Family Research-Support · Full/Part Time Full-Time · Regular/Temporary Regular · Job Code 8352P3 · Employee Class Civil Service · About the Job · The Clinical Research Associate (CRA) advises and assists University of Minnesota faculty m ...
-
Clinical Research Coordinator
2 weeks ago
Minneapolis Heart Institute Foundation Minneapolis, United StatesJob Description · Job Description · Job 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 ...
-
Clinical Research Associate
1 week ago
Inspire Medical Systems I Minneapolis, United StatesJob Description · Job Description · ABOUT 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 med ...
-
Clinical Research Associate
6 days ago
Inspire Medical Systems I Minneapolis, United StatesJob Description · Job Description · ABOUT 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 me ...
-
Clinical Research Scientist
4 days ago
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 ...
-
Clinical Research Project Lead
5 days ago
University of Minnesota Minneapolis, United StatesAbout the Job · Job Class: 8352P4 - Research Professional 4 · Working Title: Clinical Research Project Lead · Supervisor: Mary Farnsworth · Program Description: · At the University of Minnesota, Department of Surgery, our experts, care teams and researchers are advancing science ...
-
Clinical Research Associate
4 days ago
Danaher Corporation Chaska, United StatesAt first glance, you will see that for more than 80 years we have been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We are build Clinical Research, Research A ...
-
Clinical Research Associate I
4 days ago
Be The Match Minneapolis, United StatesPOSITION SUMMARY: · Please apply online using a laptop or desktop computer. · This position supports the CIBMTR CRO Services team by supporting the management of one or more multi-center clinical research studies. This position performs site monitoring visits to complete source d ...
-
Clinical Research Associate I
3 days ago
BeTheMatch Minneapolis, United StatesPOSITION SUMMARY: Please apply online using a laptop or desktop computer.This position supports the CIBMTR CRO Services team by supporting the management of one or more multi-center clinical research studies. This position performs site monitoring visits to complete source docume ...
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