Johnson & Johnson Medical Devices, a member of Johnson & Johnson family of companies, is currently recruiting for an Associate Director, Preclinical Research, Medical Device to be located in Raynham, MA, West Chester, PA, Somerville, NJ, Warsaw, IN, and Cincinnati, OH.
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 Associate Director for the DePuy Synthes in the Preclinical Center of Excellence (COE) will lead the development of plans for the preclinical evidence generation necessary to competitively position DePuy Synthes’s products for domestic and international regulatory and clinical acceptance. This individual will work closely with other functions within the preclinical COE, across other COEs and within platforms at DePuy Synthes, develop preclinical scientific staff, collaborate with internal and external partners, and actively support the DePuy Synthes business by leading high quality preclinical studies. The Associate Director of Preclinical Research for Depuy Synthes 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 Associate Director, Preclinical Research, Medical Device will:
• Elevate the Preclinical COEs contribution to product innovations and patient safety assessments across DePuy Synthes platforms using deep expertise in preclinical sciences.
• Demonstrate execution excellence and delivers preclinical evidence to offer differentiated value to advance innovation in Depuy Synthes.
• Develop robust preclinical plans and evidence based strategies for DePuy Synthes projects that minimize risk to product approvals and patient safety and increase product adoption to our customers.
• Develop strategic relationships between the Preclinical COE and DPS business partners to deliver preclinical scientific expertise to DPS NPD and LCM projects.
• Develop strong relationships with clinical, medical affairs and the Office of the Chief Medical Officer to identify potential patient risks associated with products.
• Interface effectively between FIHC members and DPS project teams, during the FIHC review process, to develop preclinical plans and evaluate data addressing patient risks without disrupting project timelines.
• Provide scientific input and rationale for highest potential projects in Depuy Synthes to effectively direct and utilize resources.
• Direct staff to execute preclinical plans and deliver preclinical evidence against the NPD pipeline goals through sourcing of preclinical studies to external vendors.
• Have direct responsibility for influencing DePuy Synthes business partners. Prioritize, assign resources, and address lifecycle needs related to functionality/efficacy 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 Depuy Synthes products in preclinical studies.
• Work across the preclinical COE’s Operations, Advanced modelling and Biocompatibility and Toxicology groups to execute product design evaluations and preclinical evidence strategies required for product approval, safety and product adoption.
• 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 (i.e. PhD, PharmD, DVM, MD, etc.) in biosciences or bioengineering is required
• A minimum of 8 years of experience in a medical device, pharmaceutical industry and/or contract research organization is required
• A minimum of 3 years of experience managing or mentoring scientific staff is required
• Experience with managing preclinical and/or clinical studies with external contract research organizations is required
• Track record of new product introduction and product life cycle management is required
• Knowledge of preclinical regulatory requirements for FDA and international agencies 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 orthopedic and/or regenerative medicine applications is required
• Familiarity with Medical Device Product Development is preferred
• This position will be located in Raynham, MA, West Chester, PA, Somerville, NJ, Warsaw, IN, or Cincinnati, OH and will require up to 40 % domestic and international travelPrimary Location
United States-Massachusetts-RaynhamOther Locations
North America-United States-Pennsylvania-West Chester, North America-United States-Indiana-Warsaw, North America-United States-Ohio-Cincinnati, North America-United States-New Jersey-SomervilleOrganization
Depuy Orthopaedics. Inc. (6029)Job Function
Clinical Research non-MDRequisition ID