- 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, ., 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, . 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
- PhD or PharmD 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,
- 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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Associate Director, Pharmacometrics
1 week ago
Jazz Pharmaceuticals Ottawa, CanadaIf you are a Jazz employee please apply via the Internal Career site · Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing me ...
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Associate Director, Pharmacometrics
1 week ago
Jazz Pharmaceuticals Ottawa, ON, Canada $136,000 - $204,000If you are a Jazz employee please apply via the Internal Career site · Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing m ...
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Associate Director, Pharmacometrics
3 weeks ago
Jazz Pharmaceuticals Ottawa, CanadaOverview: · Position Profile: · **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 cros ...
Associate Director, Pharmacometrics - Ottawa, Canada - Jazz Pharmaceuticals
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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
Required Knowledge, Skills, and Abilities
FOR CANADA-BASED CANDIDATES ONLY