Principal Clinical Scientist - Robotics & Digital Solutions

Johnson & Johnson • Cincinnati, CA

5d • Hybrid

About The Position

This position provides scientific leadership for Johnson & Johnson MedTech Surgery's Robotic Surgery Platform. The role involves close collaboration with multi-functional evidence teams, including Medical, Clinical, Pre-clinical, and Health Economics and Market Access. The Principal Clinical Scientist will be responsible for developing and delivering global evidence generation strategies, including post-market studies, investigator-initiated studies, and real-world evidence, aligned with R&D, regulatory, and commercial needs. They will ensure input and strong alignment from strategically important regional MedTech leads, design clinical trials to meet premarket and post-market needs, and strengthen capability in and drive implementation of real-world evidence to deliver efficient evidence solutions. The role also involves developing networks with key surgeons in the US, EU, and APAC to assist in the execution of Robotic Surgery clinical trials, leading cross-functional teams to interpret and disseminate evidence, and supporting clinical scientific discussions with regulatory agencies/notified bodies. Additionally, the position will provide scientific, technical, and strategic assessment of new business development opportunities and support the acquisition of innovative products, demonstrating the ability to influence, shape, and lead teams, and build successful relationships internally and develop partnerships with key business partners and customers/investigators.

Requirements

• A minimum of a Bachelor’s degree in Biological Science, Engineering, or a related field is required.
• A minimum of 8 years of related scientific / technical experience within Clinical Research required
• Expertise in clinical research science and processes along with a broad and extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations required
• Proven track record of contributing to clinical programs within a clinical or surgical research setting, on time, within budget, and in compliance with SOPs and regulations is required
• Experience working in Robotics strongly preferred
• Experience in support of global regulatory submissions for medical devices, biologics, or drugs preferred

Nice To Haves

• An advanced degree (Master’s or Ph.D.) is preferred.

Responsibilities

• Develop and deliver global evidence generation strategies, including post-market studies, investigator initiated studies, and real-world evidence, aligned to the R&D, regulatory, and commercial needs
• Ensure input and strong alignment from strategically important regional MedTech leads
• 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 in all regions
• Lead cross-functional teams to interpret and disseminate evidence, including CSRs, abstracts, and manuscripts
• 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
• Demonstrate the ability to influence, shape and lead teams
• Build successful relationships internally and develop partnerships with key business partners and customers/investigators

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Principal