Director, Medical Affairs (Monarch Flexible Robotics)

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:

Scientific/Technology

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

We are searching for the best talent for a Director, Medical Affairs (Monarch Flexible Robotics). This role must be based within a commutable distance of Santa Clara, CA and will be fully on-site.  Relocation assistance is available to qualified candidates.

Purpose: The Director, Medical Affairs (Monarch Flexible Robotics) is responsible for co-leading the development and implementation of innovative flexible robotic systems with an initial focus on Robotic Bronchoscopy. This role involves overseeing clinical research, ensuring compliance with medical regulations, supporting medical safety, and guiding the integration of advanced technologies into surgical practices. The candidate must possess a strong background in medicine and preferably technology, preferably combined with leadership experience.

Key responsibilities include strategic planning, collaboration with engineering and research teams, supporting medical safety documentation, 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 bronchoscopy procedures and requires a visionary approach to healthcare technology.

You will be responsible for:

Strategic Leadership and Vision

• Collaborate in the development and articulation of a clear vision for the integration of Flexible Robotics into healthcare systems. Assist in the formulation and execution long-term strategic plans and objectives for the flexible robotics division.

• Participate in the assessment and forecasting of future trends and challenges in flexible robotics, adjusting strategies accordingly.

Stakeholder Engagement and Communication

• Act as a medical spokesperson for Scientific Affairs in the flexible 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 flexible robotics division with the company’s overall objectives.
• Represent the company at conferences, symposiums, and industry events, delivering presentations and participating in panel discussions.

Clinical Research

• Co-develop advanced clinical research initiatives in flexible 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.
• 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 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.

Quality Assurance and Patient Safet