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The Director, Toxicology is accountable for managing the global nonclinical regulatory and investigative toxicology of assigned Jazz portfolio products, and likewise to support his/her reports overseeing those products. They will collaborate with other members of the toxicology group, Early Development non-clinical scientists, and members of Jazz cross-functional matrix teams to support the overall global nonclinical regulatory strategy of Jazz programs, from research to registration and beyond. The Director, Toxicology, reports to the Head of Toxicology.

Essential Functions

The eligible candidate is experienced in leading, supporting and managing cross-functional relationships. The Director, Toxicology has the necessary qualifications and experience for designing and conducting/monitoring toxicology studies at external CROs, interpreting and reporting toxicology findings, and enabling timely high-quality study deliverables. They will have the necessary experience for representing Toxicology in cross-functional teams supporting drug development programs and conveying Toxicology consensus position, identifying and pre-emptying potential toxicology issues that may slow or derail a program, and propose adequate de-risking strategies to address or circumvent such issues. Experience is also required in evaluating and preparing responses to inquiries from health authorities addressing global nonclinical development issues in support of IND/CTA and NDA/NDS/BLA packages. The individual has the necessary knowledge and experience to contribute to or lead early development cross-functional teams.

The Director, Toxicology:

• Is a motivated self-starter with excellent management capabilities and is a critical part of an innovative team that supports the company’s drug discovery/development effort.
• Conceptualizes, develops, revises, and finalizes toxicology (GLP and non-GLP) study designs and reports; drafts nonclinical sections for IND/CTA and NDA/BLA submissions and other regulatory documents (e.g., IB, DSUR, PSUR, etc.) to ensure regulatory compliance.
• Manages and monitors nonclinical studies (GLP and non-GLP) at external CROs per Jazz standards and ensures that global regulatory/compliance requirements are met/exceeded.
• Critically reviews and edits CRO nonclinical toxicology study reports, analyzes and interprets data, defines PK/PD and PK/Toxicity correlations, partners in PK modeling and parameter estimation, and coordinates reports’ finalization with CROs upon internal review and team communication, ensuring consistency with global regulatory and compliance requirements.
• Provides critical input on discovery and nonclinical development strategy including peer review of pharmacology/pharmacokinetic protocols, reports, and regulatory content.
• Leads and/or participates in cross functional teams as early development expert to ensure proper integration of these activities into overall project plans.
• Partners with and provides subject matter expertise to key internal functions (Regulatory, Quality, Clinical, CMC and formulations, Product Quality, Drug safety, Medical affairs) and their external contractors or collaborators.
• Contributes to departmental processes such as SOP’s, WI’s and templates.
• Maintains a current understanding of relevant literature and methodology, as well as the scientific literature related to the assigned Jazz pipeline products and R&D projects.

Required Education, Licenses, Knowledge, Skills, and Abilities

• As a minimum, Ph.D. in Toxicology, Pharmacology, Pathology, Biochemistry or Biology with extensive pharmaceutical industry experience in drug development toxicology. Board certification (e.g., DABT, ERT) is 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 in outsourcing and monitoring toxicology studies, CRO management, and interacting with study directors and other vendors (e.g., consultants) to obtain timely delivery of clear, accurate, and well-written toxicology study reports with defensible data analyses and data interpretation. 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.
• Required experience in authoring non-clinical elements of major regulatory submissions (INDs, CTAs, BLA/NDAs or sNDAs) and other regulatory documents (e.g., IB, PSUR, DSUR); preparing science-based responses to regulatory questions.
• Deep understanding of QA, regulatory, and clinical functions to guide key nonclinical safety assessment activities to support drug candidates’ success at all stages of development.
• Ability to synthesize, interpret and integrate diverse, multidisciplinary scientific data (e.g., pharmacology, pharmacokinetics, pathology).
• Experience in Discovery Toxicology as applicable to early stages (non IND-enabling) drug development would be a plus.
• Excellent verbal communication and scientific writing skills as applied to study reports and regulatory documents. Ability to interact effectively and tactfully with a variety of critical audiences within and outside the organization. Sense of urgency.
• Enjoys and thrives in a fast-paced, multi-tasked, and hands-on environment.

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