Director Toxicology

The Director, Toxicology

Required Education, Licenses, Knowledge, Skills, and Abilities

• As a minimum, Ph.D. in Toxicology, Pharmacology, Pathology, Biochemistry or Biology with extensive pharmaceutical industry experience in drug development toxicology. Board certification (e.g., DABT, ERT) is highly desirable, or demonstrable board eligibility with the intention to write the board exam.
• Extensive 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, CTAs, 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, interpret and integrate diverse, multidisciplinary scientific data (e.g., pharmacology, pharmacokinetics, pathology).
• Experience in Discovery Toxicology as applicable to early stages (non IND-enabling) drug development would be a plus.
• Excellent verbal communication and scientific writing skills as applied to study reports and regulatory documents. 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.
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• 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.
• FOR US BASED CANDIDATES ONLY
• Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is:
• Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.
• At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz’s Long Term Equity Incentive Plan.
• The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html