Director, Clinical Pharmacology & Pharmacometrics
Jazz Pharmaceuticals
9 hours ago
Remote friendly (California, United States)
United States
$188,000 - $282,000 USD yearly
Clinical Research and Development
Brief Description
- Lead efficient, innovative clinical pharmacology and/or PK/PD studies from phase 1 to phase 4 with cross-functional team members.
Job Responsibilities
- Develop clinical pharmacology strategy for multiple programs from candidate nomination for GLP toxicity studies through phase 4.
- Support clinical study protocol (phase 1–4) development; perform PK/PD data analysis/interpretation; contribute to study reports.
- Serve as clinical pharmacology Lead on cross-functional teams; own dose selection and rationale for phase 1 studies and contribute to dose selections beyond phase 1.
- Partner with pharmacometrics lead and cross-functional teams to plan and support PK/PD modeling for internal or regulatory decision-making.
- Contribute to regulatory submission sections, including IND and NDA/BLA documents.
- Address regulatory agency queries 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 Knowledge, Skills, and Abilities
- PhD or MD with significant experience in clinical pharmacokinetics and pharmacokinetic-pharmacodynamic studies and data analysis/interpretation.
- Strong understanding of clinical pharmacology and pharmacometrics principles and the drug development process.
- Working knowledge of PK/PD 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 (INDs, CTDs, NDAs, BLAs).
- Excellent written/oral communication skills and presentation skills.
- Collaborative, flexible interaction at all company levels.
Benefits (for US-based candidates only; if eligible)
- May be eligible for discretionary annual cash bonus/incentive compensation and discretionary equity grants.
- Medical, dental, vision, 401(k), and flexible paid vacation.
Application Instructions
- If a current Jazz employee, apply via the Internal Career site.
- Lead efficient, innovative clinical pharmacology and/or PK/PD studies from phase 1 to phase 4 with cross-functional team members.
Job Responsibilities
- Develop clinical pharmacology strategy for multiple programs from candidate nomination for GLP toxicity studies through phase 4.
- Support clinical study protocol (phase 1–4) development; perform PK/PD data analysis/interpretation; contribute to study reports.
- Serve as clinical pharmacology Lead on cross-functional teams; own dose selection and rationale for phase 1 studies and contribute to dose selections beyond phase 1.
- Partner with pharmacometrics lead and cross-functional teams to plan and support PK/PD modeling for internal or regulatory decision-making.
- Contribute to regulatory submission sections, including IND and NDA/BLA documents.
- Address regulatory agency queries 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 Knowledge, Skills, and Abilities
- PhD or MD with significant experience in clinical pharmacokinetics and pharmacokinetic-pharmacodynamic studies and data analysis/interpretation.
- Strong understanding of clinical pharmacology and pharmacometrics principles and the drug development process.
- Working knowledge of PK/PD 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 (INDs, CTDs, NDAs, BLAs).
- Excellent written/oral communication skills and presentation skills.
- Collaborative, flexible interaction at all company levels.
Benefits (for US-based candidates only; if eligible)
- May be eligible for discretionary annual cash bonus/incentive compensation and discretionary equity grants.
- Medical, dental, vision, 401(k), and flexible paid vacation.
Application Instructions
- If a current Jazz employee, apply via the Internal Career site.