Director, Nonclinical Development - United States
Qualified candidate is responsible for the preparation of nonclinical components of regulatory submissions for Jazz portfolio of products in support of IND and NDA/BLA packages and respond to inquiries from regulatory authorities. The candidate is responsible for coordinating pharmacology, assay and pharmacokinetic components with responsible staff. The individual has experience in evaluating and addressing global nonclinical development issues in a significant capacity in a cross functional team. The individual directs and with the help of department manager, monitors the CRO and consultant activities to deliver drug activity, safety and disposition analyses.
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 development process.
- Conceptualizing, developing, revising, and finalizing nonclinical toxicology (GLP and non-GLP) study designs, reports and nonclinical sections for IND and NDA/BLA submissions, as well as required minor and major submissions to ensure regulatory compliance. Secondary responsibilities in coordinating pharmacology, assay, pharmacokinetic components of submissions with the support of responsible staff
- Critically review and edit CRO nonclinical toxicology study reports, analyze and interpret data and coordinate report finalization.
- Ensure documentation consistent with global regulatory and compliance requirements.
- Manage nonclinical studies (GLP and non-GLP) at the CROs per Jazz vendor management SOPs and ensure global regulatory/animal use and care/compliance requirements are met/exceeded and with the help of nonclinical study monitor
- Provide analysis, interpretation, and visualization of nonclinical toxicology data in preparation for internal department communication and final study reports.
- 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.
- Ph.D. in Pharmacology /Toxicology or Biological Sciences required with 8-10 years of industry experience in conducting biologics and pharmaceutical research and development. DABT required.
- Experience with both small and large molecules, for oncology and non-oncology disease targets, during early/late stage clinical development and post-marketing.
- 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 preparing regulatory submissions, including full BLA/NDAs or significant sNDAs, as well as multiple INDs and preparing detailed science-based responses to regulatory questions.
- Deep understanding of QA, regulatory, and clinical functions to guide key nonclinical strategies, setting up drug candidates for success at all stages of development.
- Working knowledge of CMC and product quality as pertains to nonclinical safety assessment.
- 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.