We are in need of someone to be responsible for all activities related to developing and sustaining corporate offerings for toxicological assessment for medical device products with an emphasis in ISO 10993 biocompatibility testing, chemical characterization of medical devices, and risk assessment. They will provide scientific oversight of all toxicological-related activities, be responsible for preclinical strategy development, and serve as a major corporate resource for biosafety and toxicology information for medical devices and pharmaceutical materials, which may include issues related to medical device extracts and leachates, combination products and active pharmaceutical ingredients.
PhD degree in toxicology or a related biologically-based field.
At least six years of full-time experience in pharmaceutical or medical device toxicology, applying toxicology and biocompatibility concepts through project work and applied scientific decision making programs.
Post-doctoral fellowship in a specific area of toxicology and board certification from the American Board of Toxicology (DABT) or related discipline preferred.
Experience in the medical device industry preferred.
Comprehensive understanding of GLP compliance.
Must be able to clearly speak, write, read and understand English.
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the requirements listed above.