Director, Clinical Pharmacology & Pharmacometrics

Brief Description
This position is responsible for leading efficient, innovative, clinical pharmacology and/or PK/PD studies from phase 1 to phase 4 through working with cross-functional team members.

Job Responsibilities
- Development of the clinical pharmacology strategy of multiple programs spanning from candidate nomination for GLP toxicity studies through phase 4
- Support clinical study protocol (phase 1-4) development, PK/PD data analysis/interpretation, and study report
- Serve as the clinical pharmacology lead at cross-functional teams; own dose selection and rationale in phase 1 studies and contribute to dose selections beyond phase 1
- Work with the pharmacometrics lead and relevant teams to plan and support PK/PD modeling for internal or regulatory decision-making
- Contribute to preparation of regulatory submission sections including IND, and NDA/BLA documents
- Address queries from regulatory agencies during reviews and inspections
- Identify and manage consultants and vendors supporting clinical pharmacology studies
- Contribute to timely publication and/or presentation of clinical pharmacology and pharmacometrics data

Required Qualifications / Skills
- PhD or MD with significant experience in clinical pharmacokinetic and pharmacokinetic-pharmacodynamic studies and data analysis/interpretations
- Strong understanding of clinical pharmacology and pharmacometrics principles and the drug development process
- Working knowledge of PK/PD analysis software (e.g., Phoenix WinNonlin, R, ADAPT, NONMEM)
- Ability to work independently and on strong cross-functional teams
- Experience with regulatory submissions and agency interactions related to INDs, CTDs, NDAs, or BLAs
- Excellent written and oral communication skills, including presentation skills
- Collaborative and flexible communication at all levels

Application Instructions
- If you are a current Jazz employee, please apply via the Internal Career site.