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.

Application Instructions:
- Submit your resume to be considered for current and future opportunities.