Senior Scientist, Clinical Development

About the Role

Johnson & Johnson MedTech Surgery is recruiting for a Senior Scientist, Clinical Research, Robotics & Digital Solutions. This unique position will serve as a scientific contributor for the development and execution of clinical research necessary to competitively position a product for domestic and international regulatory and clinical acceptance. You will help shape the future of health through differentiated products and services, focusing on digital technology as part of a holistic approach to surgery to enhance surgical efficiency, promote better clinical outcomes, and increase patient satisfaction.

Responsibilities

• Develop and deliver appropriate global evidence generation strategies (premarket studies, postmarket studies, investigator initiated, real world evidence) aligned to R&D, Regulatory, and Commercial needs.
• Ensure input and strong alignment from key regional MedTech leads and other strategically important countries/regions in the development of clinical evidence generation strategies.
• Contribute to and support the design of appropriate studies to meet premarket and postmarket needs.
• Review, analyze, and present current literature on real-world evidence (RWE) studies.
• Meet US and EU regulatory requirements for postmarket studies.
• Execute and oversee multi-center clinical trials to meet milestones.
• Strengthen capability in and drive implementation of real-world evidence to deliver cost-effective evidence solutions.
• Ensure appropriate interpretation and dissemination of all evidence generated, including study reports, abstracts, and manuscripts.
• Support clinical scientific discussions with regulatory agencies/notified bodies to drive support of the clinical, preclinical, and regulatory strategy.
• Build successful relationships internally and develop partnerships with key business partners and customers/investigators.
• Demonstrate the ability to influence, shape, and lead teams in a team-oriented environment that embraces ownership, accountability, innovation, change, risk, and flexibility.

Requirements

• A minimum of 5 years of related scientific/technical experience within clinical research is required.
• Experience in clinical science and processes along with an understanding of product development processes, related healthcare market environment, clinical trends, and/or clinical trial regulations.
• Proven track record of contributing to clinical programs on time, within budget, and in compliance with SOPs and regulations.
• Experience working in Robotics is preferred.
• Experience in support of global regulatory submissions for medical devices, biologics, or drugs (including PMA/BLA/NDA and/or their global counterparts) is preferred.
• May require up to 25% domestic and international travel.

Benefits

• Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company’s long-term incentive program.
• Vacation – 120 hours per calendar year.
• Sick time – 40 hours per calendar year (48 hours for Colorado residents, 56 hours for Washington residents).
• 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.

Pay

The anticipated base pay range for this position is $125,000.00 - $201,250.00.