Director Toxicology

About the role

The Director, Toxicology is accountable for managing the global nonclinical regulatory and investigative toxicology of assigned Jazz portfolio products, and likewise to support his/her reports overseeing those products. They will collaborate with other members of the toxicology group, Early Development non-clinical scientists, and members of Jazz cross-functional matrix teams to support the overall global nonclinical regulatory strategy of Jazz programs, from research to registration and beyond. The Director, Toxicology reports to the Head of Toxicology.

Responsibilities

• Experienced in leading, supporting and managing cross-functional relationships.
• Designing and conducting/monitoring toxicology studies at external CROs, interpreting and reporting toxicology findings, and enabling timely high-quality study deliverables.
• Representing Toxicology in cross-functional teams supporting drug development programs and conveying Toxicology consensus position, identifying and pre‑empting potential toxicology issues that may slow or derail a program, and proposing adequate de‑risking strategies to address or circumvent such issues.
• Evaluating and preparing responses to inquiries from health authorities addressing global nonclinical development issues in support of IND/CTA and NDA/NDS/BLA packages.
• Contributing to or leading early development cross‑functional teams.
• Conceptualizing, developing, revising, and finalizing toxicology (GLP and non‑GLP) study designs and reports; drafting nonclinical sections for IND/CTA and NDA/BLA submissions and other regulatory documents (e.g., IB, DSUR, PSUR, etc.) to ensure regulatory compliance.
• Managing and monitoring nonclinical studies (GLP and non‑GLP) at external CROs per Jazz standards