Ethicon Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Sr. Medical Director aligned to the Endomechanical & Energy Platforms, located in Cincinnati, Ohio.
Ethicon offers a broad range of products, platforms and technologies—including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices—that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women’s health conditions, hernias, cancer and obesity. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of open surgery.
The Sr. Medical Director provides medical leadership to Ethicon’s Energy and Endomechanical Platforms, closely collaborating with the multi-functional evidence team. The medical director will be a member of the Energy & Endomechanical Platform Leadership Teams.
Primary responsibilities include:
- 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.
Safeguard patient safety.
Provide expert medical support to Regulatory Affairs, Communications, Legal, and Quality/Risk Management/ Product Safety teams. 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.
Participate or lead clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc., including during sponsor regulatory inspections.
Participate within the new product development R&D teams, by providing expert medical and scientific input, including conceptual and hands-on product evaluation, and clinical research perspectives. Drive the creation of ‘Target Product Profile’ documents that spell out the value proposition and potential claims of the desirable new product.
Participates as part of the Clinical, Medical and Pre-Clinical Evidence Team to achieve the strategic goals and activities of the function(s). Internally focused activities consist of pipeline engagement, clinical strategy, safety/surveillance and compliance, while externally facing activities aim to drive deeper and broader customer engagement and insight generation.
Provide support to New Business Development.
Provide scientific and medical perspectives for management of requests for Educational Grants, requests for Scientific Information, and requests for Investigator Initiated Research Grants.
Provide support to commercial teams by providing medical and scientific expertise to drive optimal business strategic direction and tactical business activities, including product launches, key scientific meetings, relationship management with leading research physicians and medical delivery system or government decision makers. Participate as an active member of the Platform Leadership Team, representing the Medical, Clinical and Pre-Clinical functions.
Provide critical evaluation of current literature and competitive activity, and in other domains where medical and scientific expertise is required.
Provide lifecycle medical affairs support (e.g. copy review, medical information requests, medical input into clinical evaluation reports, etc.).
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.
An MD/DO from an accredited school is required for this position. Training in a surgical discipline is required.
Prior clinical experience and hands on experience with minimally invasive surgical techniques is necessary.
Highly enthusiastic, self-motivated individual who will accept accountability.
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).
Experience in medical safety surveillance (drugs, biologics, or devices) and/or quality improvement activities is desirable.
Experience in the process of new product development (internal development and external partnerships) is desirable.
Demonstrated business acumen, leadership skills, mentoring skills. Ability to perform duties under general or minimal supervision.
Proven flexibility of attitude and mind set.
Ability to manage and embrace change.
Ability to build successful relationships with key opinion leaders and investigators in key business areas.
Ability to influence, shape and lead without direct reporting authority.
Ability to operate in a matrix environment and work across a complex organization.
Excellent communication, interpersonal, and reasoning skills.
Excellent communication skills, including written communication (e.g., peer review publication) and oral presentation of scientific materials and research results. Ability to write original scientific documents such as clinical summaries, regulatory filings, investigator brochures, and internal reports and scientific publications.
Teaching skills, including both oral and hands-on education of health care professionals and company employees on scientific and medical issues surrounding company products and on optimal safe and effective use of products.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Ethicon Inc. (6045)