Senior Director, Toxicology

Responsibilities:

• Design, execute, and interpret nonclinical safety studies across all phases of drug development, including GLP toxicology, reproductive toxicology, carcinogenicity, and safety pharmacology.
• Use pharmacokinetic data to justify toxicology study doses and support selection of safe and effective clinical doses.
• Oversee budgets, timelines, and study monitoring; visit GLP testing sites to review facilities and capabilities.
• Partner with clinical development, technical operations, DMPK/clinical pharmacology, discovery, and program teams; present data interpretation and strategy.
• Draft toxicology sections for regulatory documents (e.g., IND, IB, IMPD, BLA, NDA).

Requirements:

• PhD in toxicology with 10–14 years of experience overseeing toxicology programs and conducting GLP toxicology studies in the pharmaceutical industry.
• Strong understanding of global toxicology guidelines (ICH, FDA, EMA).
• Plan and execute IND-enabling studies for first-in-human.
• Plan and execute late-stage nonclinical toxicity studies.
• Expertise writing and presenting nonclinical safety data in CTD formats for regulatory submissions (e.g., IND, NDA, MAA).
• Excellent interpersonal, organizational, and communication skills.
• Strong collaboration in cross-functional, matrix teams.
• Demonstrated scientific excellence in toxicology via publications and/or conference presentations.

Preferred Qualifications:

• Experience with both large and small molecule drug development.
• Experience in hematology and rare disease drug development.
• A.B.T certification.