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Associate Director, Toxicology

Overview

Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.

Our therapeutic areas of focus include sleep and hematology/oncology - areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.

We are looking for the best and brightest talent to join our team. If you're looking to be a part of a company with an unwavering commitment to improving patients' lives and being a great place to work, we hope you'll explore our career openings and get to know Jazz Pharmaceuticals.

Position Profile

The Associate Director of Toxicology is primarily accountable for selected nonclinical regulatory and investigative toxicology tasks. He/she collaborates 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 submission strategy for assigned Jazz portfolio products, from research to registration and beyond.

The eligible candidate is experienced in designing and conducting/monitoring toxicology studies at external CROs, interpreting and reporting toxicology findings, and enabling timely high-quality study deliverables. He/she has 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 regulatory authorities addressing global nonclinical development issues in support of IND and NDA/BLA packages. The individual has the necessary knowledge and experience to lead early development cross-functional teams.

Reporting to the Head of Toxicology:

  • The individual is a self-starter with excellent management capabilities and is a critical part of an innovative team that supports the company's drug discovery/development effort.
  • Conceptualize, develop, revise, and finalize toxicology (GLP and non-GLP) study designs and reports; draft nonclinical sections for IND and NDA/BLA submissions and other regulatory documents (e.g., IB, DSUR, PSUR, etc.) to ensure regulatory compliance.
  • Manage and monitor nonclinical studies (GLP and non-GLP) at external CROs per Jazz standards and ensure that global regulatory/compliance requirements are met/exceeded
  • Critically review and edit CRO nonclinical toxicology study reports, analyze and interpret data, define PK/PD correlations, partner in PK modeling and parameter estimation, and coordinate report finalization with CROs upon internal review and team communication, ensuring consistency with global regulatory and compliance requirements
  • Provide critical input on discovery and nonclinical development strategy including peer review of pharmacology/pharmacokinetic protocols, reports, and regulatory content.
  • Leadership and participation on cross functional teams as early development expert to ensure proper integration of these activities into overall project plans
  • Partner with and provide 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.
  • Maintain a current understanding of relevant literature and methodology, as well as the scientific literature related to the specific Jazz pipeline products and R&D projects.



Requirements:

  • Ph.D. in Toxicology, Pharmacology, Pathology, Biochemistry or Biology with DABT certification and a minimum of 7 years of pharmaceutical industry experience in drug development toxicology.
  • Broad 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, 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 and interpret diverse, multidisciplinary scientific data (e.g., pharmacology, pharmacokinetics, pathology).
  • Excellent verbal communication and scientific writing skills. 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


Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

Associate Director, Toxicology

Palo Alto, CA
Full Time

Published on 06/12/2020