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

6045-Ethicon Legal Entity•Raritan, NJ

12d•Hybrid

About The Position

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. 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.

Requirements

MS or Ph.D. in Toxicology, Pharmacology, Biological Sciences, or a related field required.
A minimum of 4 years of experience in leading teams of technical subject matter experts, shaping operational changes, and navigating complexity to build new capabilities.
A minimum of 8-10 years of experience in toxicology and biocompatibility assessments and evaluation in a medical device and/or pharmaceutical company, or similar combination of professional training and multi-year experience in the industry is required.
Experience in medical devices is strongly preferred.
Demonstrated working knowledge and expertise in conducting toxicological safety assessments for chemicals and transforming risk assessment into regulatory submission documents.
A proven history of interaction with US FDA and other OUS regulatory authorities on implementation of ISO 10993, ISO 14971, and ISO 13485.
Experience in absorbable biomaterials for implantable medical devices, including experience in medical device material degradation and toxicokinetics, is required.
Familiarity with relevant industry standards, i.e., ISO 13485, ISO 10993, ISO 14971, and design control systems is required.
Experience in leading and implementing process developments is required.
Experience working in a regulated environment of medical device safety and supporting product submission and audit is required; support for worldwide market registration is preferred.
Experience in technical lab capability development and data systems development and management is preferred.
Extensive knowledge of regulatory requirements and guidelines related to toxicology and biocompatibility.
Strong critical thinking skills and the ability to analyze complex data to inform decision-making.
Exceptional communication skills, both written and verbal, with experience presenting scientific data to various audiences.
Ability to work collaboratively as a team member across various functions and disciplines in a challenging and changing environment is required.
Interacts appropriately with all internal and cross-functional partners and demonstrates effective use of conflict resolution skills.
Demonstrates technical leadership and mentorship.
Demonstrates behavior qualities including confidence, transparency, integrity, innovation, passion, patience, and tenacity.
Excellent written and verbal communication skills.
Initiative-taking and self-directed performance in an unsupervised environment and tenacity to overcome major obstacles are required.
Able to drive problem resolution efficiently and proactively through effective use of analytical and problem-solving skills.

Nice To Haves

Experience in medical devices is strongly preferred.
Experience in technical lab capability development and data systems development and management is preferred.
Support for worldwide market registration is preferred.
Depending on location, local language skills are preferrable.

Responsibilities

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.
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.
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.
Oversee the design and interpretation of toxicological studies, including in vitro and in vivo assessments, to identify potential risks associated with products.
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.
Prepare and present reports, presentations, and regulatory submissions to internal stakeholders and regulatory bodies, clearly communicating complex scientific data.
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.
Supports 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.

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
10 days Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year