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Clinical Research Director, Diabetes

📁
Clinical
📅
19000M11 Requisition #
Careers That Change Lives

Together, we can change healthcare worldwide.  At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday.  It is what makes this an exciting and rewarding place to be.

Position Description

This global position is responsible for directing clinical activities in support of new and existing Diabetes products and therapies to achieve regulatory approval.   Establish comprehensive clinical evidence by optimizing clinical trial process, which includes trial design, its infrastructure setup.  This position supports publication effort by enhancing/sharing the knowledge of products and therapies via leading clinical data-mining activities and participating in product development with collaboration with Marketing, R&D and Regulatory Departments. Finally, the position is a critical member of the overall clinical leadership team, Office of Medical Affairs.

Position Responsibilities

• Provides leadership for the development & conduct of clinical studies as it applies to product development and FDA approval.  Drives Clinical Study execution in timely fashion. 
• Understands the basic regulatory and reimbursement frameworks in Diabetes largest markets around the globe (eg, China, India, Brazil, Western Europe, Japan, Australia, Argentina, Chile, Canada, Turkey).
• Lead and manage a team to deliver in house and external evaluations of selected new products to mitigate product related technical and regulatory risk.
• Responsibility for development and execution of MA strategies that enable AIM to meet and exceed its annual and strategic plan goals.
• Interacts directly with the executive team and other senior level positions concerning significant clinical trials. 
• Represent the Office of Medical Affairs at external activities and functions as needed. 
• Develop new approach for influencing clinical trials and therapy adoption; country and area clinical related data collection, repository, and insights to related teams, and drives deeper shared business / international understanding. 
• Participate and/lead in developing global strategic clinical plan process, investment prioritization efforts, and area reviews. 
• Represent international markets and customers in the clinical trials planning process 
• Lead an innovative approach to revolutionize the clinical trial by integrating advanced statistics, technology, and process and ultimately maximize the positive clinical outcomes that timely lead to regulatory approval and build clinical evidence 
• Participate in strategy development to build clinical evidence via supporting EPG studies to bring awareness of Medtronic Diabetes products and new potential therapies globally 
• Manage expenses within budget, maximizing effectiveness and efficiency. Works within and actively promotes Medtronic’s core mission, corporate strategies, policies, procedures and Code of Conduct.
• Participate in Risk Management Development activities required by the Office of Medical Affairs 
• Participate in Medical Quality Safety Oversite as it relates to commercial device surveillance
Must Have: Minimum Requirements 

• Bachelor’s degree
• Minimum of 10 years of Clinical or Medical experience with 7+ years of managerial experience, or advanced degree with a minimum of 8 years of Clinical or Medical experience with 7+ years of managerial experience
• In depth knowledge of healthcare industry, environment and GPOs/IDNs 

Nice to Have

• Endocrinology training
• Experience in clinical trial processes
• Experience in academia, medical device, biologics or pharmaceutical industry
• Diabetes management experience
• Prior experience working with the FDA and other regulatory agencies and bodies
• Excellent communication and presentation skills - written and verbal, experience negotiating and utilizing effective influencing skills.
• Experience developing and maintaining proactive work relationships with organizational decision makers – Executives, R&D, Marketing and Regulatory within Diabetes and Medtronic
• Leadership experience in protocol development and technical writing 
• Understanding of dynamic clinical research environment including global regulations and policies 
• Experience using of business and financial measure


About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. 
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.


Physical Job Requirements 
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.  
The physical demands described within the Day in the Life section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


EEO 
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees

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