Director Toxicology (Remote)

Brief Description :

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 their direct reports and 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 direct reports. 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 (., IB, DSUR, PSUR, 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

FOR US-BASED CANDIDATES ONLY