Associate Director, Toxicology & Biocompatibility, R&D - MedTech Surgery

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Enterprise Management Job Sub Function: R&D Management Job Category: People Leader All Job Posting Locations: Raritan, New Jersey, United States of America Job Description: About Surgery Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech We are searching for the best talent for an Associate Director, Toxicology & Biocompatibility, R&D - MedTech to support our medical devices business. This role must be based within a commutable distance of Raritan, NJ, and will work a Flex/Hybrid schedule with 3 days per week on-site. There is NO remote option. The Associate Director, Toxicology & Biocompatibility will lead the development and execution of toxicology and biocompatibility evaluations for J&J MedTech Surgery medical device products. This role will be pivotal in expanding program capabilities to accelerate innovation, ensuring product safety and regulatory compliance, and guiding cross-functional teams in the integration of toxicology/biocompatibility insights into product development. This position will report to the Director of Materials Science, J&J MedTech. The Associate Director, Toxicology & Biocompatibility will lead Toxicology & Biocompatibility (Subject Matter Experts) SMEs in assessing and evaluating MedTech Surgery medical devices, primarily in Biosurgery, Wound Closure & Healing, breast implant Aesthetics & Reconstruction, and external development opportunities. Medical devices involve the assessment and evaluation of novel biosorbable materials and technology platforms to deliver innovative surgical technologies and solutions. The Associate Director will efficiently execute the biological safety evaluation of medical device products as per internal procedures and global standards and regulations. This person is responsible for ensuring the planning and execution of in vitro and in vivo biocompatibility evaluations and that products meet the requirements of biological safety according to relevant standards and regulations. You will be responsible for: People leadership and development of Toxicology & Biocompatibility (Subject Matter Experts) SMEs assessing and evaluating complex medical device materials and novel technologies, including implantable, biosorbable medical device materials. Strategic Leadership: Develop and implement robust toxicology and biocompatibility strategies aligned with business goals. Manage operational aspects of their team (e.g., workflow, performance, and compliance), as well as ensuring achievement of team goals within established timelines and budgets. Innovation: Develop enhanced capabilities leveraging technology and process improvements to advance and accelerate chemical characterization and biocompatibility assessments. Identify and implement new ways of working to accelerate speed to market and harmonize knowledge and processes across J&J MedTech. Advance internal toxicology lab capabilities to screen and de-risk materials and device prototypes. Risk Assessment: Oversee the design and interpretation of toxicological studies, including in vitro and in vivo assessments, to identify potential risks associated with products. Cross-Functional Collaboration: Work closely with R&D, Regulatory Affairs, and supply chain partners to integrate toxicology insights into product development processes. Collaborate with multiple R&D departments to develop and manage financial goals, establish, and implement business strategies, and analyze staffing needs to deliver innovative product development solutions. Collaborate across business units to leverage data and learnings to accelerate innovation. Scientific Communication: Prepare and present reports, presentations, and regulatory submissions to internal stakeholders and regulatory bodies, clearly communicating complex scientific data. Industry Engagement: Keep abreast of current trends and advancements in toxicology/biocompatibility science, representing the company in relevant industry forums and conferences. Evaluates medical device products and materials for biological safety per international medical device regulations and standards, GLP (US FDA Good Laboratory Practice) guidelines, and internal procedures. Designs, initiates, coordinates, and interprets laboratory investigations for biocompatibility and toxicology studies for medical device materials and products. Applies technical expertise to solve biocompatibility problems related to the ISO 10993 standards and regulatory authority requirements for product safety. Liaises with internal and cross-functional team members to review existing product documentation and coordinates, together with more senior staff, biocompatibility test strategies to ensure appropriate planning and execution of required testing and completion of relevant deliverables. Reviews, interprets, and summarizes testing data and ensures appropriate documentation and coordination of central documentation procedures required for risk assessment report completion. Interacts closely with and provides technical guidance and expertise to internal stakeholders (e.g., R&D, Preclinical, Clinical Affairs, Regulatory Affairs, Medical Safety, Manufacturing, Quality Engineering, and Supplier Management) and external partners on medical devices across the entire product lifecycle. Can support regulatory/notified body requests as part of audits and file/product submissions/reviews in applicable markets. Maintains effective communication of business-related issues or opportunities to next management level and if necessary, SMEs, via proper communication methods and/or tools. Identifies and evaluates potential risks and drives resolution with team members, peers, and management. Participates in continuous improvement activities and actively participates in shaping processes and procedures. Responsible for communicating business-related issues or opportunities to next management level. Responsible for following, and ensuring that subordinates follow, all company guidelines related to health, safety, and environmental practices as applicable. Responsible for ensuring personal and company compliance with all federal, state, local and company regulations, policies, and procedures. Supports regulatory/notified body requests as part of audits and file/product submissions/reviews in applicable markets. Directly interacts with notified body (TUV, BSI) and regulatory representatives Performs other duties assigned as needed. Qualifications / Requirements: MS or Ph.D. in Toxic