Johnson & Johnson Medical Devices, a member of Johnson & Johnson family of companies, is currently recruiting for a Director of Preclinical Science and Safety to be located in Irwindale, CA or Irvine, CA.
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 Director of Preclinical Science and Safety at Biosense Webster and Coherex will be a member of the senior leadership team in the Medical Device Preclinical Center of Excellence (COE) and will lead the development of the preclinical safety and efficacy strategies and enable regulatory approval for Biosense Webster’s (BWI) and Coherex products. This individual will be responsible for overseeing the conduct of high quality preclinical safety and efficacy studies and drive the strategy for development of new and enhancement of existing models to support safety and efficacy assessment. This individual will work closely with other functions within the preclinical COE, across other COEs and within BWI and Coherex R&D, develop preclinical scientific staff, collaborate with internal and external partners, and actively support the BWI and Coherex businesses. As a member of the Preclinical COE leadership team, this individual will play a leadership role in developing an industry leading preclinical organization focused on patient safety and product innovation.
The Director of Preclinical Science and Safety will:
• Elevate the Preclinical COEs contribution in the evaluation of product safety and innovation process across BWI and Coherex using deep preclinical expertise in cardiovascular electrophysiology and structural heart disease, respectively.
• Develop robust preclinical plans and evidence based strategies for BWI and Coherex projects that minimize risk to product approvals and patient safety and increase product adoption to our customers.
• Demonstrate execution excellence and deliver Preclinical evidence to offer differentiated value to advance innovation in BWI and Coherex.
• Develop strong relationships with Medical Safety, Clinical, and Medical Affairs 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 priority projects in BWI and Coherex to effectively direct and utilize resources.
• Direct staff to execute preclinical plans and deliver preclinical evidence against the NPD pipeline goals.
• Ensure quality and a high degree of excellence for preclinical study conduct
• Directly responsible for influencing BWI and Coherex R&D and cross-functional partners. Prioritize, assign resources, and address lifecycle needs related to safety/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 BWI and Coherex products in preclinical studies.
• Work with 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.
• 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 placement of the right people in the right roles.Qualifications
• A minimum of a Doctorate degree (PhD, MD, etc.) in biosciences, bioengineering, or related field is required
• A minimum of 5 years of experience in cardiovascular electrophysiology and/or structural heart disease is required
• Track record of new product introduction and product life cycle management is required
• Knowledge of preclinical regulatory requirements for FDA and international regulatory authorities is required
• Ability to work both collaboratively as a team across various functions in a challenging and changing environment is required
• Familiarity with Medical Device Product Development is required
• Demonstrated success with increasing levels of responsibility leading a group of preclinical scientists is preferred
• Track record of utilizing scientific knowledge and experience within a preclinical setting to drive effective decision-making for new product development is required
• Proven ability to build strong collaborative working relationships with key internal stakeholders is required
• Ability to navigate in a highly matrixed organization and the ability to build relationships and influence key decision-makers and business leads is required
• Experience interacting with and developing external networks with key partners and stakeholders is required
• Experience interacting and building partnerships with regulatory agencies is required
• Demonstrated experience and ability to lead change, inspire and motivate a team with a passion for talent development is required
• This position will be located in Irwindale, CA or Irvine, CA and will require up to 35% domestic and international travelPrimary Location
United States-California-IrwindaleOther Locations
North America-United States-California-IrvineOrganization
Depuy Orthopaedics. Inc. (6029)Job Function
Clinical Trial AdministrationRequisition ID
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.