[Hiring] Associate Director, Pharmacometrics @Jazz Pharmaceuticals

Role 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.

Qualifications

• PhD in pharmaceutical sciences, biomedical engineering, clinical pharmacology, or mathematical/statistical sciences
• 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 (e.g., NONMEM, Monolix, Phoenix WinNonlin, R, GastroPlus, SimCYP, ADAPT, PK Sim, etc.)
• Experience in regulatory agency interactions is a 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

Requirements

• 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.)
• 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

Benefits

• Medical, dental and vision insurance
• 401k retirement savings plan
• Flexible paid vacation
• Discretionary annual cash bonus or incentive compensation (depending on the role)
• Discretionary equity grants in accordance with Jazz’s Long Term Equity Incentive Plan