Toxicology Vice President

Job Summary

A company is looking for a Vice President, Head of Toxicology.

Key Responsibilities:

• Define and develop toxicology strategies for clinical and preclinical portfolio programs
• Manage outsourced GLP and non-GLP toxicology and safety pharmacology work, ensuring regulatory compliance
• Lead authoring and review of toxicology/nonclinical sections for regulatory documents to ensure clarity and compliance

Required Qualifications:

• Ph.D. in toxicology, pharmacology, or related discipline with 10+ years of relevant experience
• Experience in toxicology for autoimmune disease and/or oncology, with biologics experience preferred
• Strong knowledge of FDA, EMA, and ICH guidance documents and GLP regulations
• Proven track record in planning and executing IND-enabling and late-stage nonclinical toxicity studies
• Experience in authoring nonclinical safety data for regulatory submissions and responding to health authority queries