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Director of Toxicology

Omni Directs National Recruiting Services Oakland ,CA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

 Director of Toxicology

Oakland, CA

Position Summary:

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. 

Position Responsibilities:

  • 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.


Professional Profile: 

  • 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
Company Description
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Oakland, CA