We anticipate the application window for this opening will close on - 6 Jun 2025

 

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, Core Surgical Innovations (CSI) reports to the VP, Clinical Research & Medical Science, Surgical. This position is responsible for directing all global clinical research activities and programs to generate clinical evidence in support of the business. The Clinical Research Leader is responsible for developing the clinical strategy in alignment with the business, R&D and commercial strategies for the CSI Business 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 CSI Clinical Leader helps set the strategy and manages/approves funding for external physician-initiated research programs (ERP) on a global basis in partnership with the ERP Lead for Surgical. In addition, the leader will collaborate closely with the Health Economic Evidence team to provide additional value to the business.

Ideal candidate would work from our Boston, or North Haven site. We will consider candidates from Europe, with a preference for London, or remote within the US.

• 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 CSI 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.

• Assume primary accountability for clinical trial strategy and 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 represen