Clinical Research Director, Western Europe, CAS

at  Medtronic

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

MUST HAVE: MINIMUM REQUIREMENTS

• Advanced degree (Ph.D., PharmD, or MBA)
• 8 years of experience in clinical research in the medical device industry with IDE and PMA submission experience
• 7 years of progressive managerial experience in clinical research

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.

• Lead regional strategic clinical plan process, investment prioritization efforts, and area reviews in harmony with the global clinical strategic plan for CAS.
• Lead the process to define the key stakeholder needs (including but not limited to customer, regulatory agency and payer requirements) for medical evidence for the safety, efficacy, and economic outcomes necessary to establish our therapies as the standard of care.
• Provide strategic leadership to evidence generation activities including design of Clinical trials retrospective database analysis, meta-analysis, translation of clinical data to marketing messages and other health service research endeavors.
• Have a working knowledge of patient reported outcomes instruments, and development of value messages to satisfy stakeholder needs.
• Set the strategy and participate in managing and approving funding for external physician-initiated research programs (ERP).
• Develop and maintain an extensive physician network to understand customer needs and convey the evidence supporting the preferential use of our products and therapies.
• Play a leading role in the development of evidence to support clinically and economically differentiated products for specific (emerging and developed) markets. Ensure that clinical trial design is aimed at fulfilling the common and unique needs of different geographies.
• Successfully create, initiate, and conduct studies consistent with the clinical strategy and business unit objectives. In collaboration with the clinical research organization this includes Clinical Investigation Protocol (CIP) creation, budget drafting and management, trial execution, publication and evidence dissemination.
• Direct trial concept assessment and creation with functional leaders’ support
• Ensure effectiveness of CAS regional clinical activities through strong collaboration and communication with Geography, Clinical Function, Marketing, Research, Technology, Product Development and Operating Unit leadership regarding clinical research and link to the overall business strategy.
• Take primary accountability for clinical trial execution.
• Interact directly with senior leaders and executives to bring awareness and achieve resolution of significant issues concerning products and therapies detected during clinical trials.
• Collaborate with Regulatory, Reimbursement, Healthcare Economics, and Marketing to develop and execute plans to utilize the results of clinical trials to advance business objectives.
• Work cross-functionally and with external advisors, consultants and investigators to direct publication plans to ensure dissemination of clinical and economic evidence through manuscripts, society meetings presentations, payer presentations, etc.
• Interface with representatives from key functional groups including field clinical and technical staff, Product Development, Marketing, Sales, Regulatory Affairs and Quality and local governing bodies.
• Ensure the publishing of results and collaboration with physicians to make known the outcomes of studies and corresponding medical advancements.
• Represent the CAS OU on matters related to clinical evaluation of CAS Business products and therapies internally and externally.
• Represent CAS business clinical research internationally and build deeper local market knowledge and connections regarding products and strategies. Support product launches, training, and customer support plans. Collaborate with geography clinical and business leads to create local clinical strategies.
• Collaborate with Business Development in the identification, early evaluation, and due diligence of opportunities for investment or acquisition.
• Manage expenses within budget, maximizing effectiveness and efficiency.
• Work within and actively promote Medtronic’s core mission, corporate strategies, policies, procedures and Code of Conduct.