Job Description

Job Description - Medical Director, Medical Affairs, Johnson & Johnson MedTech (2406218143W)

Medical Director, Medical Affairs, Johnson & Johnson MedTech located in Cincinnati, OH

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.

This position will report into the Senior Director, Medical Affairs and will provide medical leadership globally to Johnson and Johnson’s MedTech Endomechanical and Energy Platforms.

The role will support products across the entire lifecycle in collaboration with R&D, Global Strategic Marketing, 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 Clinical Research team to drive evidence generation and dissemination activities that support product approvals, claims development, and product adoption. 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 evidence-based scientific support, training, and education.

The Medical Director will help shape the industry and build strong relationships externally with key customers and stakeholders (Key Opinion Leaders, Surgeons, 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 research, including registries.
• Have a leadership role in governance forums including Business Unit leadership teams, cross-functional product core teams, EGS teams, portfolio/strategy management teams, and Safety and Quality Review Boards.
• Engage Key Opinion leaders, 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 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.
• Provide medical interpretation of 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.
• 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 5 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 PMA/BLA/NDA and/or their global counterparts) preferred.
• Experience in medical safety surveillance (drugs, biologics, or devices) and/or quality improvement activities is preferred.
• Experience in the process of new product development (internal development and external partnerships) is desirable.
• 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.

For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit

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.

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