Global Sr Clinical Research Director, Cardiac Ablation Solutions

Medtronic•Mounds View, MN

8d•Remote

About The Position

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. A Day in the Life The Sr Clinical Research Director, Cardiac Ablations Solutions (CAS) reports directly to the Chief Medical Officer, CAS. This position is responsible for directing all global clinical research activities and programs to generate clinical and economic evidence in support of the business. The Clinical Research Leader is responsible for developing the clinical strategy in alignment with the business and R&D strategies for the Cardiac Ablation Solutions Operating Unit. The leader is also responsible for designing and driving the execution of pre-market and post-market clinical trials globally, including driving outcomes and results, and collaborating for the dissemination of the resulting evidence to internal and external stakeholders. The goal of these programs is to develop the medical evidence necessary to demonstrate safety, efficacy, economic and quality of life outcomes for the performance of our products and therapies. Programs will support global regulatory approval, reimbursement coverage through comparative effectiveness evidence, therapy adoption and new indications. The CAS Clinical Leader helps set the strategy and manages/approves funding for external physician-initiated research programs (ERP) on a global basis. In addition, the leader will collaborate closely with the Economic Evidence team to provide additional value to the business. Ideally candidate would be based on the Minneapolis, MN area - but will consider remote. Lead global strategic clinical plan process, investment prioritization efforts, and area reviews. Create the global strategic clinical plan and lead the development of regional clinical strategies. 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 manage/approve funding for external physician-initiated research programs (ERP). Develop and maintain an extensive physician network globally 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 global 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 global 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.

Requirements

Advanced degree (Ph.D., PharmD, or MBA)
15+ years of experience in clinical research in the medical device industry with IDE and PMA submission experience
10+ years of progressive managerial experience in clinical research
Have a working knowledge of patient reported outcomes instruments, and development of value messages to satisfy stakeholder needs.
Demonstrated use of business and financial measures
Excellent communication and presentation skills -- written and verbal

Nice To Haves

Deep EP knowledge (highly preferred)
Demonstrated ability to work with FDA and other global regulatory agencies and bodies
Work experience directly in a strategic clinical or marketing role
Demonstrated ability of research skills for study design and analysis
Demonstrated knowledge of Data Management and Clinical trial processes
Understanding of dynamic clinical research environment, including global regulations and policies
Strong interpersonal skills and ability to collaborate with and influence physicians, nurses, and regulators.
Demonstrated ability to work with organizational decision makers – Executives, R&D, Marketing, Regulatory, etc.
Ability to maintain proactive relationship with R&D, Marketing and Regulatory within CRM and Medtronic

Responsibilities

Lead global strategic clinical plan process, investment prioritization efforts, and area reviews.
Create the global strategic clinical plan and lead the development of regional clinical strategies.
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.
Set the strategy and manage/approve funding for external physician-initiated research programs (ERP).
Develop and maintain an extensive physician network globally 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.
Direct trial concept assessment and creation with functional leaders’ support
Ensure effectiveness of CAS global 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 global 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.

Benefits

Medtronic offers a competitive Salary and flexible Benefits Package
We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

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