Senior Medical Affairs Director, Robotics and Digital: Johnson & Johnson Medical Devices.
Company: Johnson & Johnson
Location: San Jose
Posted on: January 16, 2022
Johnson & Johnson Medical Devices is currently recruiting for a
Senior Medical Affairs Director, Robotics and Digital based in
Johnson & Johnson Medical Devices is focused on shaping the future
of digital surgery and expanding its robotics and digital solutions
offerings across the entire portfolio, with multi-specialty,
end-to-end solutions in orthopaedics, endoluminal intervention and
Ethicon, part of Johnson & Johnson Medical Devices Companies, has
made significant contributions to surgery for more than 100 years
from creating the first sutures, to revolutionizing surgery with
minimally invasive procedures. Our continuing dedication to Shape
the Future of Surgery is built on our commitment to help address
the world's most pressing health care issues and improve and save
more lives. Through Ethicon's surgical technologies and solutions
including sutures, staplers, energy devices, trocars and hemostats
and our commitment to treat serious medical conditions like obesity
worldwide, we deliver innovation to make a life-changing impact.
For more information, visit www.ethicon.com.
The Senior Medical Affairs Director provides medical leadership to
Ethicon's Robotics and Digital team, closely collaborating across
Ethicon's platforms and focus on General Surgery.
The 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 support to Regulatory Affairs, Communications,
Legal, and Quality/Risk Management/ Product Safety teams.
Contribute to 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 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
- 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
- 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
Key Opinion Leader in the field.
- An MD/DO from an accredited school is required for this
position. Training in a surgical discipline is required. x
- Prior clinical experience and hands on experience with
minimally invasive surgical techniques inclusive of robotic/digital
surgery is required. Fellowship training in Thoracic Surgurg highly
- Highly enthusiastic, self-motivated individual who will accept
- 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
- 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
- Ability to operate in a matrix environment and work across a
- Excellent communication, interpersonal, and reasoning
- 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
- 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.
- The ability to travel up to 30% [ post Covid 19] to include
domestic and international travel.
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-Redwood City-150 Shoreline Dr
North America-United States-California-San Francisco, North
America-United States-California-San Jose, North America-United
States-California-Santa Clara, North America-United
Auris Health, Inc. (6267)
Keywords: Johnson & Johnson, San Jose , Senior Medical Affairs Director, Robotics and Digital: Johnson & Johnson Medical Devices., Executive , San Jose, California
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