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Associate Director, Pharmacometrics
Jazz Pharmaceuticals. Develop pharmacometrics strategies for multiple programs .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in pharmacometrics strategies, population PK and PK/PD modeling, and regulatory submissions, with a strong foundation in clinical pharmacology and drug development processes. Capable of effectively collaborating in multidisciplinary teams while managing complex analyses and regulatory interactions.
Highest-signal resume keywords
PhD In Pharmaceutical SciencesClinical Pharmacokinetic AnalysisPopulation PK ModelingRegulatory Submissions (IND, NDA)Modeling And Simulation Software (NONMEM, Monolix)
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Population PK AnalysisPK/PD ModelingClinical Study Protocol DesignData InterpretationRegulatory Document Preparation
Soft Skills
Excellent Communication SkillsCollaborative TeamworkIndependent Work AbilityAdaptability In Fast-Paced Environments
Tools & Technologies
NONMEMMonolixPhoenix WinNonlinRGastroPlusSimCYPADAPTPK Sim
Industry Keywords
PharmacokineticsPharmacodynamicsDrug Development ProcessRegulatory Agency InteractionsModel Informed Drug Development
About the role
Key responsibilities & impact- Develop pharmacometrics strategies for 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, including dose selection and optimization
- Design clinical study protocols and analyze and interpret study data
- Prepare clinical study reports and regulatory documents, including INDs, NDAs, and IBs
- Determine scope, design, planning, and analysis of Phase 1–4 pharmacokinetic and pharmacodynamic studies
- Develop appropriate population PK models and PK/PD analyses to support development and regulatory objectives through commercialization
- Plan, prepare, and review drug development plans and regulatory filings
- Contribute relevant sections to IND and NDA/BLA regulatory submissions
- Address regulatory agency queries during reviews and inspections
- Identify and manage consultants and vendors supporting pharmacometrics analyses
- Participate effectively on cross-functional teams to integrate Model Informed Drug Development principles
Requirements
What you’ll need- 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
- Experience performing modeling and simulation tasks using software for PK/PD analysis, such as NONMEM, Monolix, Phoenix WinNonlin, R, GastroPlus, SimCYP, ADAPT, or PK Sim
- Experience in regulatory agency interactions is a plus
- Ability to work independently and collaboratively in a multidisciplinary team environment
- Ability to navigate and succeed in a fast-paced, highly matrixed work environment
- Excellent written and oral communication skills, including presentation skills
- Embody and model Jazz core values
Benefits
Comp & perks- Discretionary annual cash bonus or incentive compensation, depending on the role
- Discretionary equity grants under Jazz’s Long Term Equity Incentive Plan
- Medical insurance
- Dental insurance
- Vision insurance
- 401k retirement savings plan
- Flexible paid vacation