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About the role
- Director of Toxicology guiding global nonclinical drug safety for Jazz Pharmaceuticals’ medicines. Leading CRO studies, regulatory submissions, and cross-functional development strategy.
Responsibilities
- Manage global nonclinical regulatory and investigative toxicology for assigned Jazz portfolio products
- Support reports overseeing assigned products
- Collaborate with toxicology colleagues, Early Development nonclinical scientists, and cross-functional matrix teams
- Support global nonclinical regulatory strategies from research through registration and beyond
- Design, conduct, and monitor toxicology studies at external CROs
- Interpret and report toxicology findings and enable timely, high-quality study deliverables
- Represent Toxicology on cross-functional teams supporting drug development programs
- Convey Toxicology consensus positions and identify potential toxicology issues
- Propose de-risking strategies to address or circumvent toxicology issues
- Evaluate and prepare responses to health-authority inquiries on global nonclinical development issues
- Contribute to or lead early-development cross-functional teams
- Develop, revise, and finalize GLP and non-GLP toxicology study designs and reports
- Draft nonclinical sections for IND/CTA and NDA/BLA submissions and other regulatory documents
- Manage and monitor GLP and non-GLP nonclinical studies at external CROs
- Review and edit CRO toxicology reports, analyze and interpret data, and define PK/PD and PK/toxicity correlations
- Partner in PK modeling and parameter estimation
- Coordinate report finalization with CROs after internal review and team communication
- Provide input on discovery and nonclinical development strategy
- Lead or participate in cross-functional teams as an early-development expert
- Provide subject-matter expertise to Regulatory, Quality, Clinical, CMC and Formulations, Product Quality, Drug Safety, and Medical Affairs functions
- Contribute to departmental SOPs, work instructions, and templates
- Maintain current knowledge of relevant literature, methodologies, assigned pipeline products, and R&D projects
Requirements
- Ph.D. in Toxicology, Pharmacology, Pathology, Biochemistry or Biology
- Extensive pharmaceutical industry experience in drug development toxicology
- Board certification (e.g., DABT, ERT) highly desirable, or demonstrable board eligibility with the intention to write the board exam
- Extensive experience with small and large molecules, with a preference for oncology and CNS indications
- Experience outsourcing and monitoring toxicology studies, managing CROs, and interacting with study directors and vendors
- Capacity to synthesize and communicate complex information
- Capacity to propose practical mitigation (de-risking) strategies
- Strong knowledge of FDA, EMA, and ICH guidance documents and GLP regulations
- Experience authoring non-clinical elements of major regulatory submissions, including INDs, CTAs, BLAs, NDAs or sNDAs
- Experience preparing science-based responses to regulatory questions
- Deep understanding of QA, regulatory, and clinical functions
- Ability to synthesize, interpret and integrate multidisciplinary scientific data, including pharmacology, pharmacokinetics, and pathology
- Experience in Discovery Toxicology for early-stage drug development is a plus
- Excellent verbal communication and scientific writing skills
- Ability to interact effectively and tactfully with critical audiences inside and outside the organization
- Sense of urgency
- Ability to thrive in a fast-paced, multitasked, hands-on environment
Benefits
- Discretionary annual cash bonus or incentive compensation
- Discretionary equity grants
- Medical insurance
- Dental insurance
- Vision insurance
- 401k retirement savings plan
- Flexible paid vacation
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