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Associate Director, Preclinical Toxicology
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- The Associate Director of Preclinical (Toxicology and biocompatibility) will support a portfolio of drug, medical device, drug packaging system, and/or combination product development and global registration.
- This individual will apply expertise and in-depth applied knowledge of toxicology, biocompatibility, and related scientific knowledge to find innovative solutions to develop nonclinical regulatory strategies, solve technical challenges and move new product development and product support projects forward.
- The role will report to Director of Preclinical and Toxicology assessment team responsible drugs and devices for Peritoneal dialysis, Hemodialysis, and Acute therapies (~$5B product portfolio with global reach in more than 100 countries).
- Independently develops and authors responses to submission deficiencies/questions (e.g., 510K, PMA, EU MDR).
- Must possess a working knowledge of toxicology and preclinical regulatory requirements as they relate to the development and registration of medical devices and an eagerness to learn and develop scientific competence beyond their current skills.
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