Johnson & Johnson Medical Devices, a member of Johnson & Johnson family of companies, is currently recruiting for a Sr. Director of Preclinical Research, Medical Device to be located in Cincinnati, OH or Somerville, NJ.
Johnson & Johnson Medical Devices is currently $20 billion in World Wide sales. The business is expected to experience solid growth over the next 5 to 7 years. Johnson & Johnson Medical Devices contains key surgical platforms such as Wound Closure, Orthopedics, Open and Minimally Invasive Stapling, Energy, Biosurgery, Aesthetics, ENT, and Cardiovascular surgical products.
The Ethicon franchise Senior Director in the Preclinical Center of Excellence (COE) will lead the development of plans for the preclinical evidence generation necessary to ensure patient safety and competitively position Ethicon’s products for domestic and international regulatory and clinical acceptance. This individual will work closely with other functions and franchises within the preclinical COE, across other COEs and within platforms at Ethicon, develop preclinical scientific staff, collaborate with internal and external partners, and actively support the Ethicon business by leading high quality preclinical studies. The Senior Director of Preclinical Research for Ethicon will serve as a member of the Preclinical COE leadership team in developing an industry leading preclinical organization focused on innovation and patient safety.
The Sr. Director, Sr. Director of Preclinical Research, Medical Device will:
• Oversee the development and implementation of robust preclinical plans and evidence based strategies for Ethicon projects that ensure patient safety, minimize risk to product approvals and increase product adoption to our customers.
• Elevate the Preclinical COEs contribution in the innovation process across Ethicon platforms using deep diseased based knowledge and expertise in surgical skills.
• Direct execution excellence and deliver Preclinical evidence to offer differentiated value to advance innovation in Ethicon.
• Develop strong relationships with clinical, medical affairs and the Office of the Chief Medical Officer to identify potential patient risks and use of products that can be evaluated in preclinical studies.
• Work cross-functionally with clinical, medical affairs, HEMA and commercial to identify and develop robust preclinical data packages and disseminate the results.
• Provide scientific input and rationale for highest potential projects in Ethicon to effectively direct and utilize resources.
• Direct staff to execute preclinical plans and deliver preclinical evidence against the NPD pipeline goals.
• Directly responsible for influencing Ethicon business partners. Prioritize, assign resources, and address lifecycle needs across all platforms as they arise.
• Connect externally and engage strategically with, regulators, customers, thought leaders, academia, CROs and other external partners to anticipate industry trends and unmet needs, facilitate innovation, enhance product development and physician testing of Ethicon products in preclinical studies.
• Representing Preclinical COE at the GMB and R&D leadership team, as needed.
• Work with the preclinical COE’s Operations and Biocompatibility and Toxicology groups to execute product design evaluations and preclinical evidence strategies required for product approval, safety and product adoption.
• Work with other COE franchise leaders to prioritize COE resources to deliver on top priority projects across MD
• Identify appropriate animal and bench top models that may be used to drive product development and safety assessments. Work within COE and across company sectors to develop models.
• Identify technologies and products that can be leveraged across franchises based on their mechanism of action to expand their use into new disease states.
• Talent Development: Develop and strengthen the preclinical talent pipeline. Ensure right people in right roles across the Preclinical scientific ladder.Qualifications
• A minimum of a Doctorate degree (e.g. PhD, DVM, or equivalent degree) in biosciences, bioengineering, or related field is required
• A minimum of 10 years of managing a group comprised of senior scientific staff (Phd. DVM, MD) in a pharmaceutical and/or medical device industry is required
• Track record of new product introduction and product life cycle management is required.
• Extensive knowledge of preclinical regulatory requirements for regulatory submissions for FDA and international agencies, with proven track record of successful approvals of submissions to FDA and other international agencies is required.
• Extensive experience with interacting and communicating with regulatory agencies around preclinical submission strategies and data is required.
• Ability to work both collaboratively as a team across various functions in a challenging and changing environment is required.
• Demonstrated leadership skills to serve as a change agent to identify needs and solutions, implement and support the transformation of a function is required.
• Scientific knowledge and experience in developing therapies for gastrointestinal, metabolic or thoracic-related diseases/complications is preferred.
• Familiarity with Medical Device Product Development is preferred.
• This position will be located in Cincinnati, OH or Somerville, NJ and will require up to 35% domestic and international travelPrimary Location
United States-Ohio-CincinnatiOther Locations
North America-United States-New Jersey-SomervilleOrganization
Depuy Orthopaedics. Inc. (6029)Job Function
Clinical Research non-MDRequisition ID