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 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. Learn more at https: //www.jnj.com

Job Function:

Medical Affairs Group

Job Sub Function:

Medical Affairs – MD

Job Category:

People Leader

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson's Family of Companies is recruiting for a Senior Director, Medical Affairs- OTTAVA Surgical Robotics. The location for this position is Santa Clara, CA.

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 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. Learn more at https: //www.jnj.com/.

The Senior Director, Medical Affairs- OTTAVA Surgical Robotics is responsible for co-leading the development and implementation of innovative surgical robotic systems. This role involves overseeing clinical research, ensuring compliance with medical regulations, and guiding the integration of advanced technologies into surgical practices. The candidate must possess a strong background in medicine and technology, coupled with leadership experience in managing multidisciplinary teams.

Key responsibilities include strategic planning, collaboration with engineering and research teams, and maintaining a focus on improving patient outcomes through technological advancements. The role demands excellent communication skills for liaising with healthcare professionals, regulatory bodies, and industry partners. This position is pivotal in shaping the future of surgical procedures and requires a visionary approach to healthcare technology.

Major Duties & Responsibilities:

Strategic Leadership and Vision

• Collaborate in the development and articulation of a clear vision for the integration of MIS/Surgical Robotics into healthcare systems. Assist in the formulation and execution long-term strategic plans and objectives for the surgical robotics division.
• Participate in the assessment and forecasting of future trends and challenges in surgical robotics, adjusting strategies accordingly.

Team Management and Development

• Directly oversee and manage a multidisciplinary team, potentially including 5-10 members consisting of clinical engineers, medical science liaisons, and preclinical operations staff. Cultivate a culture of excellence, innovation, and continuous learning within the team.

• Provide mentorship and career development opportunities for team members.

Clinical Research and Innovation

• Co-develop advanced clinical research initiatives in surgical robotics, ensuring they align with the latest medical standards and patient safety protocols. Participate in oversight of the entire lifecycle of clinical research projects, from conception through to publication.

• Drive innovation in surgical robotics, staying ahead of technological advancements and competitive developments.

• Act as a strategic partner with medical evidence generation colleagues in Preclinical Research, Clinical Development, and Health Economics Market Access teams to develop and execute global strategies for evidence generation for new and existing products to support regulatory approval/clearance, health technology assessment, customer access, and post-marketing support.

• Provide scientific and medical perspectives for management of requests for Educational Grants, requests for Scientific Information, and requests for Investigator Initiated Research Grants.

• Provide critical evaluation of current literature and competitive activity, and in other domains where medical and scientific expertise is required.

Regulatory Compliance and Ethical Standards

• Ensure strict adherence to all relevant regulatory and ethical standards, including FDA regulations and international compliance requirements. Partner with colleagues in Regulatory for the preparation and submission of regulatory documents and reports.

• Maintain the highest ethical standards in all research and development activities.

Stakeholder Engagement and Communication:

• Act as the primary medical spokesperson for Scientific Affairs in the surgical robotics platform, engaging with external stakeholders including healthcare professionals, regulatory bodies, and academic institutions. Facilitate effective communication between different departments and ensure alignment of the surgical robotics division with the company’s overall objectives.

• Represent the company at major conferences, symposiums, and industry events, delivering presentations and participating in panel discussions.

Quality Assurance and Patient Safety

• Ensure that all surgical robotics products and services meet the highest standards of quality and safety. Implement rigorous quality control processes and continuously monitor for potential improvements.

Data Analysis and Reporting

• Co-Analyze clinical data and research findings to inform decision-making processes. Regularly report progress, challenges, and outcomes to senior management and relevant stakeholders.

• Collaboration with R& D and Marketing Teams

• Work closely with research and development teams to guide the design and functionality of new surgical robotics technologies. Collaborate with marketing teams to accurately represent the capabilities and benefits of the surgical robotics platform to potential clients and the broader market.

• Provide lifecycle medical affairs support (e.g. copy review, medical information requests, medical input into clinical evaluation reports, etc.).

Budget Management and Resource Allocation

• Oversee the budget for the Scientific Affairs division, ensuring efficient allocation of resources. Implement cost-control measures without compromising on innovation and research quality.

• Provide Evaluation Activities for New Business Development.

Qualifications

• MD, DO or MB degree is required

• A minimum of 15 years relevant experience in post-graduate medical education (beyond initial licensure) including: specialty residency; fellowship or subspecialty training; clinical practice; dedicated research or other related training/experience is required.

• Board Certification (or equivalent) in a surgical specialty is strongly preferred.

• Experience leading in medical affairs, clinical development or related roles in research / medical device industry is required.

• Preferred experience in Minimally Invasive Surgery, Robotic Surgery.

• Five plus years people/organizational leadership experience within a complex matrixed environment is required.

• Two plus years surgical robotics experience is required.

• Business Experience in highly compliant environment is preferred.

• The ability to travel (domestic and international) up to 30% of the time is required.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

The anticipated base pay range for this position is:

The anticipated base pay range for this position is 193000 to 333500. California Bay Area - The anticipated base pay range for this position is 238000 to 382950.

Additional Description for Pay Transparency: