Associate Director - Biocompatibility & Toxicology

Position Overview

Lead and support the global biocompatibility program for all sustaining and new products, with a focus on biological safety testing strategy development, toxicological and biological risk assessments, ISO 10993 related process and documentation improvement, and optimization of chemical characterization testing.

Responsibilities

• Serve as a senior subject matter expert (SME) in biocompatibility, chemical characterization, and toxicology, with a focus on developing testing strategies for biological safety evaluations.
• Author, review, and facilitate biocompatibility and chemical characterization test plans, assessments, and reports; assess data to support business and regulatory objectives.
• Consult on safety testing strategies for new product development (NPD) and investigational devices, including regulatory implications.
• Provide deep scientific analysis of safety data, including toxicological risk assessments and gap analyses, aligned with current standards and regulatory guidance.
• Write and maintain SOPs to ensure the adequacy of biological, chemical, and toxicological documentation.
• Support internal teams by addressing biocompatibility and toxicology issues, resolving problems, and maintaining communication across functions.
• Advise on global regulatory requirements (US, EU, APAC, etc.) for medical device submissions, and assist with responses to regulatory agency queries.
• Participate in core teams, design and risk reviews, and support recordkeeping for biological safety assessments and test documentation.
• Lead and contribute to biocompatibility training programs across functional groups based on current standards and regulations.
• Maintain expertise in applicable standards and industry practices related to medical device
• Collaborate with cross-functional teams including R&D, Regulatory, Analytical Chemistry, and Quality to ensure timely project execution.
• Manage change control activities and support internal/external audits by maintaining biocompatibility readiness documentation.
• Act as liaison with CROs/vendors, including oversight of SOWs, POs, and related documentation.
• Lead cost- and time-saving initiatives, including developing in-house in vitro test capabilities.
• May lead special projects or corporate initiatives as assigned.
• Lead and manage direct reports in the R&D team, specifically those with biological safety and chemical characterization responsibilities. Set clear goals, providing regular feedback, conduct performance reviews, and foster a positive team environment. Managers would also be expected to delegate tasks effectively, mentor team members, and address any challenges or barriers impacting employee performance.
• Create and manage biological safety and chemical characterization testing budgets effectively, including but not limited to AOP planning (operating and capital expenses), resource planning, consulting and testing costs. Plan sample counts for testing.

Qualifications

• 10+ years experience at testing CRO and/or medical device manufacturer highly preferred.
• A MS degree in Toxicology or closely related field (biology, chemistry, biochemistry, biomedical engineering). Will consider candidates with a BS and 15+ years of related experience.
• A PhD degree in Toxicology or related field (biology, chemistry, biochemistry, biomedical engineering). Diplomate of the American Board of Toxicology (DABT) preferred.
• Applied knowledge and understanding of toxicology principles and best practices.
• Applied knowledge of risk assessment methodologies, including the toxicological evaluation of medical device materials.
• Applied knowledge of regulatory standards and global regulatory requirements with respect to medical device and combination products.
• Experience with running GLP and nGLP studies
• Create and manage biological safety and chemical characterization testing budgets effectively,
• Excellent written and verbal communication skills.
• Proficient at project management, with ability and proven track record to plan, manage and develop multiple projects to consistently meet deadlines.
• Foundational knowledge to identify and interpret Regulatory/Legal documents and determine the required compliance activities.
• Ability to lead a team and work with members and other departments, as well as external customers, vendors, consultants, and regulatory authorities.
• Refined technical, analytical, and critical thinking skills.
• Strong written and oral communication and presentation skills.
• Strong leadership and team management skills.
• Excellent interpersonal skills and ability to work in a team-based, collaborative environment.
• Ability to independently plan, organize, coordinate, manage and execute assigned tasks and multiple projects.
• Domestic and international travel may be required.