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:

Raritan, New Jersey, United States of America

Job Description:

Johnson and Johnson is currently seeking a Medical Director, Global Medical Affairs, Biosurgery located in Raritan, NJ

About Surgery

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.

Your unique talents will help patients on their journey to wellness. Learn more at https: //www.jnj.com/medtech

This position will report to the Senior Director, Medical Affairs, Biosurgery and will provide medical leadership globally to Ethicon’s Biosurgery Platform. The role will serve as a strategic partner with colleagues in other functions throughout the product lifecycle, including but not limited to R& D (Research and Development), Global Strategic Marketing (GSM), Commercial, and HEMA (Health Economics and Market Access). This role will also provide strong input on long-term product opportunities and portfolio strategies. The Medical Director will work closely with the Preclinical and Clinical Development teams in support of evidence generation and dissemination activities that support product approvals, claims development, and product adoption and lifecycle management. This role will also work closely with the R& D teams during product development and with marketing and commercial teams during product launches to provide training and education.

The Medical Director will help shape the industry and build strong relationships externally with key customers and stakeholders (Key Opinion Leaders [KOLs], Surgeons, Health Regulatory Agencies, Professional Societies, etc.) to anticipate industry trends, understand clinical/medical insights, unmet medical needs and global standards of care to deliver quality products/solutions.

• Work with business partners including but not limited to R& D, Clinical Research, Regulatory Affairs, Communications, Legal, Quality & Compliance, Preclinical, Health Economics & Market Access, and Professional Medical Education to provide leadership with product development, pre- and post-approval clinical studies, regulatory approval/clearance, downstream claims, safety assessments, and product launch and training for key products within the franchise portfolio.
• Have a significant role in the development and execution of product and/or procedural evidence generation and dissemination strategies for company sponsored and investigator-initiated studies (IIS), including registries.
• Have a leadership role in governance forums including Business Unit leadership teams, cross-functional product core teams, EGS (evidence generation strategy) teams, portfolio/strategy management teams, and Safety and Quality Review Boards.
• Engage KOLs, Professional Societies, Payers and Providers to understand trends in care and uncover critical insights to support product innovation and portfolio strategies.
• Provide medical and scientific insights to drive optimal business strategic direction and business activities including product launches, key scientific meetings, relationship management with leading research physicians and medical delivery system or government decision makers.
• Provide lifecycle medical affairs support (e.g. copy review, medical information requests, medical input into clinical evaluation reports, etc.).
• Provide medical oversight for the development of materials to be used for clinical study execution (investigator brochures, training materials, etc.).
• Work closely with Medical Safety team to ensure adverse events from clinical research studies are reviewed, trended and escalated as needed.
• Collaborate with Pre-clinical team on clinically relevant ex-vivo and in-vivo models development for evaluation of Biosurgery products
• Provide medical interpretation of preclinical and clinical study outcomes and assist with the development of communication and education strategies for the dissemination of the results.
• Work with Regulatory and Clinical partners to prepare reports on clinical investigations in preparation for submission to regulatory agencies and/or for publication, to meet evidence requirements for new products and for renewals.
• Contribute to medical input into risk management plans and failure mode analysis during product development and safety signal detection and post-market surveillance post-launch.
• Review and approve educational, promotional and reporting materials for use by internal stakeholders. Strategize and prioritize publication proposals in collaboration with Clinical Science.
• Align strategy, budget and resource allocation in close partnership with the cross-functional partners.
• Attend key Scientific Meetings, participating as an oral presenter. Write key scientific and clinical publications highlighting critical findings in the field and cementing role as KOL in the field.
• Safeguard patient safety. Support Sr. Medical Director in Pharmacovigilance activities, reviewing periodic safety reports and adverse events assessment related to biologics.
• Engage in environmental scanning and competitive analysis, new product development, clinical research, new business development, product training during investigational trials as well as during product launches, and may provide case coverage during trials.

Requirements

• An MD/DO and a minimum of 10 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 required.
• A current license to practice is preferred.
• Board Certification and Fellowship in a surgical specialty is strongly preferred.
• Five or more years’ experience in clinical practice as an attending-level physician preferred.
• Clinical research experience in medical devices, biologics, or drugs is strongly preferred.
• Experience in support of global regulatory submissions for medical devices, biologics or drugs is desirable (including IDE/PMA/BLA and/or their global counterparts) is strongly preferred.
• Experience in medical safety surveillance (drugs, biologics, or devices) and/or quality improvement activities is strongly preferred.
• Experience in the process of new product development (internal development and external partnerships) is preferred.
• Strong leadership skills and demonstrated ability to build successful relationships with internal and external partners required.
• Strong communication and negotiation skills required.
• Capability, expertise and success in building teams to meet the needs of a global set of businesses serving different clinical specialties or therapeutic areas is desirable.
• Demonstrated success in medical data generation, interpretation and publication preferred.
• Experience with the use of natural language processing in research and literature review is desirable.
• Experience in product risk evaluation and mitigation is preferred.
• An academic mindset capable of analyzing data to build context for innovation, find and analyze literature to inform decision making for clinical trials is desirable.

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:

The anticipated base pay range for this position is 194000 to 334650.

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. · Please use the following language: • 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