Director Toxicology

  • Jazz Pharmaceuticals
  • California
  • time-alarm-solid 05-16-2024

Job Description

Jazz Pharmaceuticals is looking for an experienced Director of Toxicology to oversee the global nonclinical regulatory and investigative toxicology of assigned Jazz portfolio products. The ideal candidate will collaborate with the toxicology group, Early Development non-clinical scientists, and cross-functional matrix teams to support the overall global nonclinical regulatory strategy of Jazz programs.

Responsibilities

  • Lead and manage direct reports in designing, conducting, and monitoring toxicology studies.
  • Draft nonclinical sections for regulatory submissions to ensure compliance.
  • Manage nonclinical studies at external CROs and ensure regulatory requirements are met.
  • Provide input on discovery and nonclinical development strategy.
  • Participate in cross-functional teams and provide expertise to key internal functions.

Requirements

  • Ph.D. in Toxicology, Pharmacology, Pathology, Biochemistry, or Biology.
  • 8-10 years of pharmaceutical industry experience in drug development toxicology.
  • Experience in authoring nonclinical elements of regulatory submissions.
  • Strong knowledge of FDA, EMA, and ICH guidance documents and GLP regulations.
  • Excellent verbal communication and scientific writing skills.

Benefits

  • Competitive salary range with total compensation packages.
  • Annual cash bonus or incentive compensation.
  • Equity grants and various benefits offerings including medical, dental, vision insurance, and 401k plan.
  • Fast-paced and innovative work environment.