Senior Pharmacometric Lead — PK/PD Strategy (Remote)

Jazz Pharmaceuticals, Inc.; Philadelphia (Philadelphia County); Remote; USD 164,000 - 246,000; Full time

Job summary

Jazz Pharmaceuticals, Inc. in the United States seeks a pharmacometrics leader to guide population PK/PD analyses across multiple development programs, from research through registration.

You will design, perform and report PK/PD modeling and exposure–response analyses, support dose selection, and contribute to regulatory submissions while collaborating with cross-functional teams in a fast-paced, matrixed environment.

Qualifications

• PhD in pharmaceutical sciences, biomedical engineering, clinical pharmacology, or mathematical/statistical sciences with 5+ years of PK/PD data analysis.
• Strong understanding of pharmacometrics and the drug development process.
• Experience with PK/PD modeling software (NONMEM, Monolix, Phoenix WinNonlin, R, GastroPlus, SimCYP, ADAPT, PK-Sim).
• Experience with regulatory interactions is a plus.
• Ability to work independently and in cross-functional teams.
• Excellent written and oral communication and presentation skills.
• Embody Jazz core values.

Responsibilities

• Develop the pharmacometrics strategy for multiple programs.
• Design, perform, interpret and report population PK, PK/PD and exposure–response analyses.
• Provide hands-on PK/PD modeling and simulation support for development projects.
• Design study protocols, analyze data, and prepare regulatory documents (INDs, NDAs, IBs).
• Plan and review drug development plans and regulatory filings.
• Contribute to regulatory submissions (IND, NDA/BLA) and respond to agency queries.
• Identify and manage consultants and vendors for pharmacometrics analyses.
• Collaborate on cross-functional teams applying MIDD principles.

Education

PhD in pharmaceutical sciences

Tools

NONMEM

Monolix

Phoenix WinNonlin

R

GastroPlus

SimCYP

ADAPT

PK Sim

Job description

Jazz Pharmaceuticals, Inc. in the United States seeks a pharmacometrics leader to guide population PK/PD analyses across multiple development programs, from research through registration.

You will design, perform and report PK/PD modeling and exposure–response analyses, support dose selection, and contribute to regulatory submissions while collaborating with cross-functional teams in a fast-paced, matrixed environment.