Senior Scientist Clinical Research

Janssen Global Services - Santa Clara, CA

Full-time - Senior

Santa Clara, CA

About the position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and where solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Johnson & Johnson MedTech Surgery is recruiting for a Senior Scientist Clinical Research, located in Santa Clara, CA or Cincinnati, OH, USA. For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges. We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve, which is why we foster a culture of inclusion and belonging where all perspectives, abilities, and experiences are valued and our people can reach their potential. In this position, you will provide scientific expertise for Johnson & Johnson MedTech Surgery's Robotic Surgery Platform, collaborating closely with multi-functional evidence teams.

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.
• Design clinical trials to meet premarket and post-market needs.
• Strengthen capability in and drive implementation of real-world evidence to deliver efficient evidence solutions.
• Lead cross-functional 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 and line extensions, including during sponsor regulatory inspections.
• Demonstrate the ability to influence, shape, and lead teams.
• Build successful relationships internally and develop partnerships with key business partners and customers/investigators.

Requirements

• A minimum of a BS degree in Biological Science, Engineering, or a related field is required; an advanced degree (MS or PhD) is preferred.
• Minimum of 5 years of related scientific/technical experience in clinical research.
• 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.
• 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 US regulations.
• Exceptional abilities to communicate and effectively interact with individuals in a professional setting.
• Ability to work independently and collaborate effectively within a team.

Nice-to-haves

• Experience in robotics.
• Experience in support of global regulatory submissions for medical devices.

Benefits

• Medical, dental, vision, life insurance coverage.
• 401(k) retirement plan participation.
• Long-term incentive program eligibility.
• Vacation - up to 120 hours per calendar year.
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year.
• Holiday pay, including Floating Holidays - up to 13 days per calendar year.
• Work, Personal and Family Time - up to 40 hours per calendar year.