We seek a Pharmacometrician for exciting opportunities within our growing firm to work with industry-leading consultants in modeling and simulation. The successful candidates will possess an understanding of pharmacometrics, pharmacokinetics, PK/PD, and modeling concepts and applications. Excellent writing, communication, and mathematical skills are requisite to success in this position.
- Contribute to or conduct PK/PD analysis and population PK modeling and simulation using industry standard software tools, including model building and refinement
- Contribute to or conduct Model Based Drug Development exercises for clients.
- Assist with the design, analysis, and interpretation of studies involving sparse sampling and provide guidance to optimize PK sampling and dosing strategies
- Contribute to or conduct non-compartmental and compartmental pharmacokinetic analysis using Phoenix WinNonlin® with rich sampling data as needed
- Assist with providing strategic advice to clients and developing clinical pharmacology strategic plans and clinical protocol development
- Work with other consultants to prepare and review population PK reports and other clinical pharmacology documents.
- Assist with development and validation of programming language in R for PK, PK/PD, and population PK analyses.
- Author clinical protocols and clinical pharmacology and pharmacokinetic sections of regulatory documents, including INDs, NDAs, briefing packets, Investigator Brochures, etc.
- Support client’s nonclinical efforts to ensure that sufficient preclinical PK data exists to design and support clinical studies and model development
- Maintain current knowledge of advancements in modeling, simulation, PK, and PK/PD science, regulatory guidance documents, FDA rulings, internal SOPs, and internal working practices to be able to contribute ideas to improve technologies and procedures for PK practices
Advanced degree preferred. Unique ability to understand and develop sophisticated mathematical equations describing drug exposure and response is central to this position.