Remote Associate Director, Pharmacometrics — PK/PD Strategy

Jazz Pharmaceuticals, Inc.; United States; Remote; USD 164,000 - 246,000; Full time

Job summary

Jazz Pharmaceuticals, Inc. is seeking a senior pharmacometrics expert to lead population PK/PK‑PD analyses and interpretation for international drug development programs.

You will partner with cross‑functional teams to drive Model‑Informed Drug Development from research through registration. The role requires a PhD with 5+ years in clinical PK/PK‑PD data analysis, strong regulatory interaction experience, and hands‑on modeling using major PK software.

Qualifications

• PhD in pharmaceutical sciences, biomedical engineering, clinical pharmacology, or mathematical/statistical sciences with 5+ years of PK/PK-PD data analysis experience.
• Strong understanding of clinical pharmacology and pharmacometrics principles.
• Experience in modeling & simulation using PK/PD software (NONMEM, Monolix, Phoenix WinNonlin, R, GastroPlus, SimCYP, ADAPT, PK-Sim).

Responsibilities

• Develop pharmacometrics strategy for multiple programs.
• Design, perform, interpret and report population PK/PK-PD analyses.
• Provide hands-on PK/PD modeling and simulation support for development projects.
• Prepare CSRs and regulatory documents (INDs, NDAs, IBs) including PK/PD analyses.
• Plan and review drug development plans and regulatory filings.
• Contribute to regulatory submissions (IND, NDA/BLA).
• Address queries from regulatory agencies during reviews.
• Oversee consultants and vendors for pharmacometrics analyses.
• Collaborate with cross-functional teams to apply Model-Informed Drug Development principles.

Skills

PK/PD modeling

Data analysis

Regulatory communications

Written and verbal communication

Education

PhD in pharmaceutical sciences or related field

Tools

NONMEM

Monolix

Phoenix WinNonlin

R

GastroPlus

SimCYP

ADAPT

PK-Sim

Job description

Jazz Pharmaceuticals, Inc. is seeking a senior pharmacometrics expert to lead population PK/PK‑PD analyses and interpretation for international drug development programs.

You will partner with cross‑functional teams to drive Model‑Informed Drug Development from research through registration. The role requires a PhD with 5+ years in clinical PK/PK‑PD data analysis, strong regulatory interaction experience, and hands‑on modeling using major PK software.