Johnson & Johnson Medical Devices, a member of Johnson & Johnson family of companies, is currently recruiting for a Sr. Director of Biocompatibility and Toxicology, Preclinical, Medical Device to be located in Raynham, MA, Somerville, NJ, Cincinnati, OH, Warsaw, IN, or West Chester, PA.
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 Senior Director of Biocompatibility and Toxicology group in the Preclinical Center of Excellence (COE) will dead the toxicological and biocompatibility evaluation of products and technologies required for product approvals and patient safety across MD. This individual will work closely with preclinical franchise leadership to understand project requirements, priorities and timelines to effectively assign resources for preclinical safety assessments. The individual will interface with key internal stakeholders and regulatory agencies to deliver robust preclinical assessments that meet regulatory approval and ensure patient safety. The Senior Director of Biocompatibility and Toxicology 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, Biocompatibility and Toxicology, Preclinical & Medical Device will:
• Direct staff conducting toxicological and biocompatibility evaluation of products and technologies required for product approvals and patient safety across MD.
• Partner with preclinical franchise leaders in the development of robust preclinical plans and evidence strategies to meet NPD goals and ensure patient safety.
• Develop and implement biocompatibility and toxicology resourcing strategy that delivers executional excellence to projects.
• Work with the preclinical COE’s Operations, Advanced modelling and Franchise leaders to execute product design evaluations and preclinical evidence strategies required for product approval and patient safety across MD.
• Drive interactions with project teams early in the process to identify potential risks to projects and develop robust Biological Evaluation Matrix.
• Interface closely with the Office of the Chief Medical officer to evaluate safety assessments of new and existing products for our patients.
• Facilitate dialogue with key partners (Marketing, R&D, Clinical, Medical, Regulatory, HEMA, Quality) at the right time in the development process to ensure; Right Patient Needs are addressed, Right Evidence Data to support Claims and Rights Research is conducted.
• Oversee, manage and prioritize resources to conduct biocompatibility and toxicology assessments for projects across MD. Provide scientific input and rationale for highest potential projects to effectively direct and utilize resources.
• Partner with preclinical franchise leaders to develop preclinical project budgets to address patient safety.
• Provide leadership and strong participation in the development of ISO standards and FDA guidance documents for MD testing.
• Interface with regulatory agencies and external thought leaders to anticipate and shape preclinical testing requirements required for ensuring approval and patient safety.
• 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 biocompatibility and toxicology models.
• Talent Development: Develop and strengthen the preclinical talent pipeline. Ensure right people in right roles across the Preclinical scientific ladder.