Ethicon Inc. member of Johnson & Johnson's Family of Companies, is currently recruiting for a Medical Affairs Head for Digital & Robotic Surgery, located in Menlo Park, CA.
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.
Ethicon’s long-term vision is to use digital technology as part of a broad approach to surgery across the episode of care to improve surgical efficiency, promote better clinical outcomes and increase patient satisfaction.
Primary Responsibilities Include:
Use clinical research, robotic surgical expertise and collaborative partnering capabilities to define, guide and support the scientific vision and strategy for Ethicon’s Digital Surgery Platform, collaborating closely with the multi-functional evidence teams: Medical, Clinical, Pre-clinical and Health Economics and Market Access.
Delivers on the portfolio’s evidence strategies:
Provides Medical and Clinical input into Target Product Profile and Development Plans.
Able to independently conduct data generation strategies and gap analyses to support the brand from a medical, commercial and market access perspective.
Develop and implement evidence generation strategies (Pre-and Post-Market approval- studies, Investigator Initiated, Real World Evidence) aligned to the needs of the R&D, Regulatory and Commercial organization.
Align strategy, budget and resource allocation in close partnership with the cross-functional and regional partners in Regulatory and Medical and (Pre-) Clinical Affairs, as well as integrate the health economic and market access aspects, to allow market leadership while insuring patient safety.
Plan and bring timely resources on board (internal and external).
Explore new trends in data-collection (i.e. Real World Data, Predictive Analytics)
Leads 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.
Help create and execute the vision beyond Robotic Surgery: including elements such as advanced instrumentation and visualization, data analytics, machine learning and an integrated OR connectivity.
Ensures the Medical & Scientific teams are on the forefront of emerging science, surgery, trends, technologies and unmet needs through presence at key scientific meetings, relationship management with leading research physicians, medical delivery systems and government decision makers, critical evaluation of current literature and competitive activity, and in other domains where surgical and scientific expertise is required.
Closely collaborate with the Safety Officers to identify risks and develop risk mitigation plans.
Liaise with the pre-clinical team on testing and validation strategies for the system and the surgical tools.
Closely collaborate with the clinical engineers on procedural development.
Responsible for leading the creation of Life Cycle Medical affairs (e.g. copy review, medical information requests, medical/clinical input CERs, etc.)
An MD/DO from an accredited school is required for this position. Training in a surgical discipline is required. Board Certification or equivalent (prior or current) is required. Prior clinical experience and extensive hands on experience with the robotic approach is required to fulfill the specific needs for this role.
Proven track record in delivering clinical research programs within surgical (device) research setting, from clinical trial design to execution, including successful dissemination.
Deep understanding of clinical trends and the related healthcare market environment, with deep connections in the digital, med tech ecosystem in California.
Ability to build and lead a team of scientists to provide scientifically rigorous strategic and scientific clinical research input across new product development projects.
Experience in support of global regulatory submissions for medical devices, biologics, or drugs (including PMA/BLA/NDA and/or their global counterparts) is desirable.
Experience in medical safety surveillance (drugs, biologics, or devices) and/or quality improvement activities is desirable.
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.
United States-California-Menlo Park-
Ethicon Inc. (6045)