Toxicologist
Category: Research & Development| Country: United States | State: California | City: Palo Alto | Type: Regular, Full Time | Job ID: 4290
Same Job Available in Two Locations
Palo Alto, California, United States
Philadelphia, Pennsylvania, United States

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.

Responsibilities:

The Senior Manager is primarily accountable for nonclinical investigative/regulatory toxicology, working in collaboration with nonclinical pharmacology and pharmacokinetic scientists, accountable to cross-functional matrix teams, to drive the overall global nonclinical regulatory submission strategy for multiple Jazz portfolio products, from research to registration and beyond.

Eligible candidate has experience in evaluating and responding to inquiries from regulatory authorities addressing global nonclinical development issues in support of IND and NDA/BLA packages.  The individual represents the department at the project team level, and/or leads early development cross-functional teams, while directing outsourced activities in collaboration with study monitors, to enable timely high-quality project deliverables.

Job Responsibilities and Requirements:

  • The individual is a self-starter with excellent management capabilities and is a critical part of an innovative team that to support the company’s drug discovery/development.
  • Conceptualize, develop, revise, and finalize toxicology (GLP and non-GLP) study designs, and, reports; draft nonclinical sections for IND and NDA/BLA submissions, as well as required minor and major submissions to ensure regulatory compliance.
  • Manage and monitor nonclinical studies (GLP and non-GLP) at the CROs per Jazz standards and ensure 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 and DABT required with about 5 years of industry experience in biopharmaceutical development. Ph.D. in Biological Sciences acceptable with DABT certification.
  • Broad experience with small and large molecules, oncology and/or non-oncology targets
  • Experience in outsourcing, vendor management, and interfacing with internal Finance and legal groups, establishing and managing consultants and CROs driving timely delivery of clear, accurate, and well-written nonclinical study data; as well as real-time communication of unexpected outcomes and mitigation plans.
  • Strong knowledge of FDA, EMA, and ICH guidance documents including GLP regulations
  • Required experience in authoring major regulatory submissions (INDs, BLA/NDAs or significant sNDAs), preparing / presenting science-based responses to regulatory questions.
  • Deep understanding of QA, regulatory, and clinical functions to guide key nonclinical safety assessment activities, setting up drug candidates for success at all stages of development.
  • Ability to synthesize and interpret diverse, multidisciplinary data sets.
  • Strong verbal communication skills accompanied by scientific writing skills.
  • 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.

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