Toxicology Vice President

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

May 1, 2025 - 18:52

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