Johnson & Johnson Careers
Franchise Medical Director Trauma - Fixed Term 9-12 months
Requisition ID: 1805685678W
Johnson & Johnson's Medical Devices Division is currently recruiting for a Franchise Medical Director Trauma, as a part of the Global Surgery and Global Orthopedic Medical Affairs Group. This position can be located in West Chester, PA or Solothurn, Switzerland.
The Global Surgery and Global Orthopedic Medical Affairs Centers of Excellence has recently integrated to support all operating companies under Global Surgery and Global Orthopedics, and this position is focused on the Trauma and CMF businesses in Global Orthopedics.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial (CMF), power tools and biomaterials. Building on the legacy and strengths of two great companies, we have created one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
Franchise Medical Director Trauma
- Is an integral part of driving innovation, value and safety in all we do. This Director has several key responsibilities:
- Serves as a strategic partner with colleagues in the New Product Development, Clinical Research and New Business Development by providing expert medical and scientific input to product ideation and development, including conceptual and hands-on product evaluation, and medical or clinical research perspectives.
- Provides medical insights/expertise to the development teams for the risk assessment review for new products, and reviews and approves the final risk management report for all new products.
- Engage Key Opinion leaders, Professional Societies, Payers and Providers to understand trends in care, uncover critical insights and provide expert medical response to unsolicited medical requests.
- Collaborates with evidence generation colleagues in Preclinical Research, Clinical Research, and Evidence-Based Medicine (EBM) teams in the USA and internationally to develop global strategies for evidence generation for new and existing products in order to support regulatory approval/clearance, health technology assessment, customer access and post-marketing support.
- Provides scientific and medical expertise, medical oversight and approval for clinical trial concept, design, analysis and reporting of clinical research in assigned areas. Provides medical input and expertise in the analysis of study results. Works with Regulatory and Clinical partners to approve all reports on clinical investigations in preparation for submission to regulatory agencies and/or for publication, to meet evidence requirements.
- Oversees MDs (internal MDs or consultants) who perform the role of medical monitor for company sponsored clinical studies. May perform the role of medical monitor for certain company sponsored pre-approval clinical studies.
- Provides medical oversight for the development of materials to be used by Clinical Operations for study execution (investigator brochures, training materials, etc).
- Provide support to Franchise Marketing, R&D, Communications, Legal, QA/Risk Management / Product Safety and Commercial teams by providing medical and scientific insights to drive optimal business strategic direction and tactical business activities.
- Accountable for the medical content of internal product documentation and regulatory submissions for new products and for renewals. Approves Design History Files, Technique Guides and Clinical Evaluation Reports (CERs) as part of the creation of product-specific design dossiers/technical files.
- A minimum of a MD/MB/DO or equivalent is required. Additional advanced degrees are preferred. A current license to practice is required, and Board Certification or an equivalent is strongly preferred.
- A minimum of 10 years relevant experience in post graduate medical education (beyond initial licensure) is required including: specialty residency, fellowship or subspecialty training, clinical practice, dedicated research, or other related advanced training/experience. Two or more years’ experience in clinical practice as an attending level physician is required. Significant experience with clinical research is required. Experience and focused training in Orthopedic Surgery, Orthopedic Trauma and/or CMF is required.
- Previous industry experience leading Medical/Clinical/R&D teams in a regulated, commercial biomedical or medical device business is preferred.
- Membership and leadership roles in specialty Professional Societies is desirable.
- Capability, expertise and success in building teams to meet the needs of a global set of businesses serving different clinical specialties or therapeutic areas will be needed. Demonstrated success in medical data generation, interpretation and publication highly preferred. Experience in product risk evaluation and mitigation is preferred.
- The candidate must have strong leadership skills and demonstrated ability to build successful relationships with internal and external partners globally. Strong communication and negotiation skills are needed to successfully influence and implement policy with key customers and partners. In addition, the leader must be able to collaborate well with multiple partners and work effectively in a matrix environment.
- This position will be located in West Chester, PA or Solothurn, Switzerland and may require up to 35% domestic and international travel.
- This role is a temporary role/ assignment for about 9-12 months.
Synthes GmbH (7111)