Principal Clinical Scientist – Robotics, Digital Solutions

Responsibilities

• Provide scientific leadership for Johnson & Johnson Med Tech Surgery's Robotic Surgery Platform.
• Collaborate closely with multi-functional evidence teams, including Medical, Clinical, Pre-clinical and Health Economics and Market Access.
• 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 Med Tech 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.

• A minimum of a Bachelor's degree in Biological Science, Engineering, or a related field is required.
• An advanced degree (Master's or Ph.D.) is preferred.
• 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.