- Jazz Pharmaceuticals
- California
- 05-16-2024
Job Description
If you are a Jazz employee, please apply via the Internal Career site
Jazz Pharmaceuticals plc is seeking a Director of Toxicology to manage the global nonclinical regulatory and investigative toxicology of assigned portfolio products. This role involves collaborating with cross-functional teams, overseeing toxicology studies at CROs, and ensuring regulatory compliance in drug development programs.
Key Responsibilities:
- Lead and manage direct reports in toxicology activities
- Design and monitor toxicology studies, interpret findings, and prepare regulatory documents
- Provide toxicology expertise in cross-functional teams and communicate risks and mitigation strategies
- Contribute to drug development strategy, regulatory submissions, and QA processes
- Interpret scientific data and interact effectively with internal and external stakeholders
Requirements:
- Ph.D. in Toxicology, Pharmacology, or related field
- 8-10 years of pharmaceutical industry experience in drug development toxicology
- Experience in managing CROs, authoring regulatory submissions, and interacting with health authorities
- Strong knowledge of FDA, EMA, and ICH guidelines, GLP regulations
- Excellent communication and scientific writing skills
Compensation:
The compensation package for this role ranges from $192,000 to $288,000 annually, based on qualifications and experience. Additional benefits include a discretionary annual cash bonus, equity grants, medical insurance, retirement savings plan, and flexible paid vacation.
Jazz Pharmaceuticals is an equal opportunity employer committed to fair compensation practices.
For more details, visit our careers page.