- Jazz Pharmaceuticals
- Remote
- 05-16-2024
Job Description
Jazz Pharmaceuticals is seeking a Director of Toxicology to manage the global nonclinical regulatory and investigative toxicology of assigned products. The Director will collaborate with cross-functional teams to support the regulatory strategy from research to registration. Reporting to the Head of Toxicology, the Director will lead, support, and manage direct reports and provide expertise in toxicology studies and regulatory compliance. This position requires a Ph.D. in Toxicology or related field, board certification or eligibility, and 8-10 years of pharmaceutical industry experience.
Responsibilities
- Design and monitor toxicology studies at external CROs.
- Ensure regulatory compliance in nonclinical sections for submissions.
- Participate in cross-functional teams to support drug development programs.
- Provide subject matter expertise to internal functions and external collaborators.
Requirements
- Ph.D. in Toxicology, Pharmacology, or related field.
- 8-10 years of experience in small and large molecules, preferably in oncology and CNS indications.
- Experience in authoring non-clinical elements of regulatory submissions.
- Strong knowledge of FDA, EMA, and ICH guidance documents.
- Excellent communication and scientific writing skills.
Benefits
- Competitive compensation package based on qualifications and experience.
- Medical, dental, and vision insurance.
- 401k retirement savings plan and flexible paid vacation.
- Possibility of discretionary annual cash bonus and equity grants.