We seek a Pharmacokineticist for an entry level opportunity within our growing firm. The successful candidate will possess an understanding of clinical PK and PK/PD concepts and applications; knowledge of drug metabolism, physiology, and animal PK studies is a plus. Excellent writing, communication, and mathematical skills are requisite to success in this position.
- Contribute to or conduct non-compartmental and compartmental pharmacokinetic analysis using Phoenix WinNonlin®.
- Contribute to or conduct PK/PD analysis and population PK modeling and simulation using industry standard software tools.
- Assist with the design, analysis, and interpretation of clinical pharmacology studies (renal, hepatic, TQT, ADME, DDI, BE/BA, SAD, MAD, etc.) and provide guidance to optimize pharmacokinetic sampling and dosing strategies.
- Assist with providing strategic advice to clients and developing clinical pharmacology strategic plans.
- Work with other consultants to prepare and review 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 execute clinical studies.
- Maintain current knowledge of advancements in 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.
An advanced degree (MS, Ph.D., Pharm.D) in pharmaceutical sciences and 1-2 years of industry experience is required as well as having excellent writing skills and experience with Phoenix WinNonlin. Experience with NONMEM and R is a plus. The ability to apply scientifically sound principles efficiently in the analysis and interpretation of pharmacokinetic data is a necessity. Experience in working with small, emerging pharmaceutical and biotech companies and with small molecules and biologics is a plus. Other combinations of appropriate experience and education will also be considered.