Director Toxicology

Job Description

We are looking for a dynamic Director of Toxicology to join Jazz Pharmaceuticals, a global biopharmaceutical company dedicated to transforming the lives of patients. As the Director, you will oversee the global nonclinical regulatory and investigative toxicology of Jazz portfolio products, collaborating with cross-functional teams to drive the regulatory strategy from research to registration.

Key Responsibilities

• Lead and manage toxicology studies at external CROs, ensuring high-quality study deliverables.
• Provide critical input on discovery and nonclinical development strategy.
• Author non-clinical elements of major regulatory submissions and prepare science-based responses to regulatory questions.
• Interact with key internal functions and external collaborators to support drug candidates' success.

Requirements

• Ph.D. in Toxicology, Pharmacology, Pathology, Biochemistry, or Biology.
• 8-10 years of pharmaceutical industry experience in drug development toxicology.
• Experience in outsourcing and monitoring toxicology studies, understanding of FDA, EMA, and ICH guidance documents.
• Expertise in authoring non-clinical elements of regulatory submissions and strong knowledge of QA and regulatory functions.
• Excellent communication skills and ability to work effectively in a fast-paced environment.

Compensation and Benefits

• Base pay range: $192,000-$288,000.
• Eligibility for discretionary annual cash bonus, equity grants, medical, dental, and vision insurance, 401k plan, and flexible paid vacation.
• Equal opportunity employer offering fair and competitive compensation packages.