- Jazz Pharmaceuticals
- Remote
- 05-16-2024
Job Description
If you are a Jazz employee please apply via the Internal Career site
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company dedicated to developing life-changing medicines for patients with serious diseases. We are looking for a Director of Toxicology to manage the nonclinical regulatory and investigative toxicology of our portfolio products. The Director will play a key role in supporting the global nonclinical regulatory strategy from research to registration and beyond. This position reports to the Head of Toxicology and requires experience in toxicology study design, interpretation, and regulatory compliance.
Responsibilities
- Lead, support, and manage direct reports in toxicology.
- Design and conduct toxicology studies at external CROs.
- Interpret toxicology findings and prepare study deliverables.
- Represent Toxicology in cross-functional teams to address potential toxicology issues.
Requirements
- Ph.D. in Toxicology, Pharmacology, Pathology, Biochemistry, or Biology.
- 8-10 years of pharmaceutical industry experience in drug development toxicology.
- Expertise in FDA, EMA, and ICH guidance documents and GLP regulations.
- Experience authoring non-clinical elements of major regulatory submissions.
- Strong scientific writing and communication skills.
Benefits
- Competitive compensation based on qualifications and experience.
- Comprehensive benefits package, including medical, dental, and vision insurance.
- Retirement savings plan and flexible paid vacation options.
- Diverse and inclusive work environment with opportunities for growth and development.