Director of Toxicology

Job Summary

To support the global nonclinical regulatory strategy, the full-time salaried Director of Toxicology will manage toxicology studies, collaborate with cross-functional teams, and ensure compliance with regulatory requirements while working remotely or from specified locations.

Key responsibilities

• Manage and monitor GLP and non-GLP toxicology studies at external CROs, ensuring compliance with global regulatory standards
• Draft and finalize nonclinical sections for regulatory submissions and provide critical input on drug development strategies
• Lead cross-functional teams and serve as a subject matter expert in toxicology, addressing potential issues and proposing mitigation strategies

Required qualifications

• Ph.D. in Toxicology, Pharmacology, Pathology, Biochemistry, or Biology with extensive pharmaceutical industry experience
• Experience with small and large molecules, preferably in oncology and CNS indications
• Strong knowledge of FDA, EMA, and ICH guidance documents and GLP regulations
• Proven experience in authoring non-clinical elements of major regulatory submissions
• Excellent scientific writing skills and the ability to synthesize complex scientific data