Strategic Lead, Pharmacometrics (Remote)

Jazz Pharmaceuticals; Philadelphia (Philadelphia County); Remote; USD 180,000 - 240,000; Full time

Job summary

Jazz Pharmaceuticals is seeking a senior pharmacometrician to lead population PK/PK-PD analyses and exposure–response modeling across international programs. You will work with cross-functional teams to shape strategies from research through regulatory submission.

The role requires a PhD with 5+ years of PK/PD modeling expertise and hands-on experience with modeling software. Strong communication and regulatory interaction skills are essential in a fast-paced, matrixed environment.

Qualifications

• PhD in pharmaceutical sciences, biomedical engineering, clinical pharmacology, or mathematical/statistical sciences with 5+ years of experience in PK/PK-PD data analysis.
• Strong understanding of clinical pharmacology and pharmacometrics in drug development.
• Experience performing modeling and simulation using PK/PD software (e.g., NONMEM, Monolix, Phoenix WinNonlin, R, GastroPlus, SimCYP, ADAPT, PK-Sim).
• Regulatory interactions experience is a plus.
• Ability to work independently and in cross-functional teams in a fast-paced, matrixed environment.
• Excellent written and oral communication, including presenting results.
• Embody and model Jazz core values.

Responsibilities

• Develop pharmacometrics strategy for multiple programs.
• Design, run, interpret, and report population PK/PK-PD and exposure–response analyses.
• Provide hands-on PK/PD modeling and simulation support for development projects.
• Contribute to study protocols, data analyses, and regulatory document preparation (INDs, NDAs, IBs).
• Plan and review drug development plans and regulatory submissions.
• Engage with regulatory agencies during reviews and inspections.
• Coordinate with cross-functional teams to apply Model-Informed Drug Development (MIDD) principles.

Skills

Communication skills

Team collaboration

Independent work

Regulatory interactions

Education

PhD in pharmaceutical sciences / biomedical engineering / clinical pharmacology / math statistics

Tools

NONMEM

Monolix

Phoenix WinNonlin

R

GastroPlus

SimCYP

ADAPT

PK-Sim

Job description

Jazz Pharmaceuticals is seeking a senior pharmacometrician to lead population PK/PK-PD analyses and exposure–response modeling across international programs. You will work with cross-functional teams to shape strategies from research through regulatory submission.

The role requires a PhD with 5+ years of PK/PD modeling expertise and hands-on experience with modeling software. Strong communication and regulatory interaction skills are essential in a fast-paced, matrixed environment.