Associate Director, Pharmacometrics
Jazz Pharmaceuticals • Philadelphia, PA6d • Remote
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Associate Director, Pharmacometrics
Jazz Pharmaceuticals•Philadelphia, PA
•Remote
About The Position
This position leads efficient and innovative population pharmacokinetic (PK), PK/PD, and exposure-response plans, analyses, interpretation, and reporting in support of international drug development programs. Working through cross-functional teams, the Associate Director leads pharmacometrics strategy for multiple Jazz portfolio products, from research through registration and beyond. The role provides hands-on modeling and simulation support for development projects, including dose selection and optimization. It also contributes to study design and reporting, drug development plans, regulatory filings, and responses to regulatory agencies. The position supports effective integration of Model Informed Drug Development (MIDD) principles across cross-functional teams.
Requirements
- PhD in pharmaceutical sciences, biomedical engineering, clinical pharmacology, or mathematical/statistical sciences.
- At least 5 years of experience analyzing clinical pharmacokinetic and pharmacokinetic-pharmacodynamic data.
- Strong understanding of clinical pharmacology, pharmacometrics principles, and the drug development process.
- Prior experience performing modeling and simulation using software for PK/PD analysis.
- Ability to work independently and collaboratively in a multidisciplinary team environment.
- Ability to succeed in a fast-paced, highly matrixed work environment.
- Excellent written and oral communication skills, including presentation skills.
- Embody and model Jazz core values.
Nice To Haves
- Experience interacting with regulatory agencies.
Responsibilities
- 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.
- Contribute to clinical study protocol design, data analysis and interpretation, and study reporting, including preparation of clinical study reports and regulatory documents.
- Determine the 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 needs from concept or existing project stages through commercialization.
- Plan, prepare, and review drug development plans and regulatory filings.
- Contribute relevant sections to 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.
- Participate effectively on cross-functional teams to integrate Model Informed Drug Development principles.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k) retirement savings plan
- Flexible paid vacation
- May be eligible for discretionary annual cash bonus or incentive compensation, depending on the role.
- May be eligible for discretionary equity grants.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
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