Manager, Clinical Research, Robotic Surgery

Ethicon Endo-Surgery, a division of Johnson & Johnson, is recruiting for a Manager, Clinical Research, Robotics & Digital Solutions, located in either Santa Clara, California or Cincinnati, Ohio!

Johnson & Johnson MedTech

Johnson & Johnson MedTech has been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we seek to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.

Ethicon’s long-term vision is to use digital technology as part of a holistic approach to surgery across the episode of care to improve surgical efficiency, promote better clinical outcomes and increase patient satisfaction. This position will provide scientific leadership for Ethicon’s Robotics & Digital Surgery Platform, collaborating closely with multi-functional evidence teams, including Medical, Clinical, Pre-clinical and Health Economics and Market Access.

Key Responsibilities:

• Develop and deliver global evidence generation strategies (pre-and post-market approval studies, investigator initiated, real world evidence) aligned to the needs of R&D, Regulatory, and Commercial
• Ensure input and strong alignment from strategically important regional MedTech leads in the development of evidence generation strategies
• Design clinical trials to meet the premarket and post-market needs
• Strengthen capability in and drive implementation of real-world evidence to deliver efficient evidence solutions
• Develop network with key surgeons in US, EU, and APAC to assist in execution of Robotic Surgery clinical trials for registration in all regions
• Lead teams to interpret and disseminate evidence, including CSRs, abstracts, manuscripts, etc.
• Support clinical scientific discussions with regulatory agencies/notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc., including during sponsor regulatory inspections
• Provide scientific, technical, and strategic assessment of new business development opportunities and support acquisition of innovative products that will position our company for future growth and success
• Demonstrate the ability to influence, shape and lead teams
• Build successful relationships internally and develop partnerships with key business partners and customers/investigators