Associate Director, Pharmacometrics

Jazz Pharmaceuticals, Inc.; 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

Brief Description:

This position is responsible for leading efficient, innovative population PK, PK/PD, exposure-response plan, analysis, interpretation, and reporting to support international drug development programs. Working through cross-functional teams, this individual will lead the overall pharmacometrics strategy for multiple Jazz portfolio products, from research to registration and beyond.

Essential Job Functions:

Job Responsibilities

• Development of the pharmacometrics strategy of multiple programs
• Design, perform, interpret and report population PK, PK/PD and exposure-response analyses
• Provide hands-on population PK and PK/PD modeling and simulation support for development projects, e.g., dose selection and optimization
• Clinical study protocol design, data analysis/interpretation, and reporting of studies by preparing CSRs and various regulatory documents (INDs, NDA’s, IB’s, etc.). This includes determining scope, design, planning and analysis of phase 1-4 pharmacokinetic and pharmacodynamics studies, including developing appropriate population PK models, and PK/PD analysis required from a development and regulatory perspective to take a project from its existing or concept stage to commercialization.
• Plan, prepare and review drug development plans and regulatory filings
• Contribute to the preparation of relevant sections of regulatory submissions including IND, and NDA/BLA documents
• Address queries from regulatory agencies during reviews and inspections
• Identify and manage consultants and vendors supporting pharmacometrics analyses
• Effective participation on cross functional teams to ensure effective integration of Model Informed Drug Development (MIDD) principles

Required Knowledge, Skills, and Abilities

• PhD in pharmaceutical sciences, biomedical engineering, clinical pharmacology, or mathematical/statistical sciences with 5+ years of experience with clinical pharmacokinetic and pharmacokinetic- pharmacodynamic data analysis
• Strong understanding of clinical pharmacology and pharmacometrics principles and the drug development process
• Prior working experiences in performing modeling and simulation tasks using software for PK/PD analysis (eg, NONMEM, Monolix, Phoenix WinNonlin, R, GastroPlus, SimCYP, ADAPT, PK Sim, etc.)
• Experience in regulatory agency interactions is plus
• Ability to work both independently and collaboratively in a multidisciplinary team environment
• Ability to navigate and be successful in a fast-paced, highly matrixed work environment
• Excellent written and oral communication skills including good presentation skills
• Embody and model Jazz core values

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