Director of Toxicology
Seeking Subject Matter Expert (SME) for a Director of Toxicology role with biocompatibility and toxicology expertise in Extractables & Leachables for our organization. This accredited toxicologist will provide comprehensive toxicological support and leadership for therapeutic and combination drug/device projects. This person will interface with internal stakeholders (scientists, engineers, regulatory), external specialists and sub-specialists, CRO, and regulatory authorities to provide support for programs from the research stage through commercialization.
- Senior-level contributor responsible for proactively establishing toxicology strategy and providing oversight on execution for Class III medical device, therapeutics, and combination drug/device programs. Communicate toxicology strategy to cross-functional project teams, ensuring alignment with business needs.
- Lead and/or manage the design, monitoring and interpretation of In Vitro and In Vivo non-clinical safety studies conducted under Good Laboratory Practices (GLP).
- Author/review SOPs, toxicology reports and regulatory summaries in collaboration with cross-functional teams, contract laboratories and suppliers.
- Identify and manage external laboratories to perform toxicological studies. Analyze and provide oversight for all toxicology studies such as biocompatibility testing: extractable and leachable, chemical characterization and biological impact evaluations.
- Identify and manage external sub-specialty SME in toxicology.
- Ensure compliance with global regulatory requirements and standards related to biological safety such as ISO 10993.
- Author regulatory submissions and responses to evaluations
- Represent the company professionally as required to effectively author and communicate toxicology information.
- Ph.D. in Toxicology, Biochemistry, Biomedical Engineering, Bioengineering, Biology with 5+ years’ experience or MS Degree with 10+ years’ experience in biocompatibility, toxicology, and/or process validation
- Fundamental understanding of ISO 10993 standards
- Experience with biomaterials, toxicological assessments, E & L analysis for materials, container-closure systems, processes for medical device manufacturing, and biocompatibility assessment
- Must have expertise in toxicity due to related impurities generated from E & L studies and how to classify and justify safe use of Class III medical devices
- Strong ability to critically review detailed scientific information and assess areas for improvement
- Ability to work well with diverse cross-functional teams
- Strong leadership and influencing skills in a cross-functional organizational setting
- DABT Certification is required.
- Demonstrated ability to critically review detailed scientific information and assess areas for improvement through a strong publication track record.
- Requires some domestic and international travel
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