- Jazz Pharmaceuticals
- Remote
- 05-16-2024
Job Description
We are looking for a talented Director of Toxicology to join our global biopharmaceutical company, Jazz Pharmaceuticals. As the Director of Toxicology, you will be responsible for managing the nonclinical regulatory and investigative toxicology aspects of our portfolio products. You will collaborate with cross-functional teams to support the global nonclinical regulatory strategy, from research to registration and beyond. Reporting directly to the Head of Toxicology, this role requires a strategic leader with extensive experience in toxicology studies, regulatory compliance, and drug development programs.
Responsibilities
- Lead, manage, and support direct reports in toxicology initiatives.
- Design and monitor toxicology studies at external CROs, interpret findings, and ensure high-quality deliverables.
- Represent Toxicology in cross-functional teams, identifying and addressing potential issues that may impact program timelines.
- Prepare responses to health authorities and contribute to early development strategies.
- Provide subject matter expertise to internal functions and collaborate with external partners.
- Review and finalize study reports, ensuring compliance with global regulations and consistency with program goals.
Requirements
- Ph.D. in Toxicology, Pharmacology, Pathology, Biochemistry, or Biology.
- 8-10 years of experience in small and large molecule drug development, preferably in oncology and CNS indications.
- Expertise in managing toxicology studies, interacting with vendors, and authoring regulatory submissions.
- Deep knowledge of FDA, EMA, and ICH guidance, GLP regulations, and nonclinical safety assessments.
- Strong communication skills, ability to analyze scientific data, and thrive in a fast-paced environment.
- Experience in Discovery Toxicology and board certification (DABT, ETR) are desirable.
We Offer
- Competitive compensation package within the range of $192,000-$288,000.
- Discretionary annual cash bonus, equity grants, and comprehensive benefits.
- Opportunity to work in a dynamic, innovative, and collaborative environment.