Director, Medical Affairs (Monarch Flexible Robotics)

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 Safety

• Ensure that all flexible 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 flexible robotics technologies. Collaborate with marketing teams to accurately represent the capabilities and benefits of the flexible 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.).

Provide Evaluation Activities for New Business Development as needed

Qualifications/Requirements :

• Advanced Degree (M.D., D.O., or M.B.) degree is required.
• Minimum of 7+ 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 in Interventional Pulmonology required.
• 2+ years flexible robotics experience is required.
• Board Certification (or equivalent) in an associated specialty is strongly preferred .
• Experience leading in medical affairs, clinical development or related roles in research/medical device industry is strongly preferred .
• 2+ years people/organizational leadership experience within a complex matrixed environment is strongly preferred .
• 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 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is $224,000 to $385,250 based on experience. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be 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.

Employees are eligible for the following time off benefits:

• 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 of Work, Personal and Family Time - up to 40 hours per calendar year

Additional information can be found through the link below: https://www.careers.jnj.com/employee-benefits

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The anticipated base pay range for this position is :
The anticipated base pay range for this position is $224,000 to $385,250.

Additional Description for Pay Transparency:
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be 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. Employees are eligible for the following time off benefits: 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 of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits