Associate Director, Pharmacometrics

Saved 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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