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Pharmacokineticist

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.

Responsibilities:

  • 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.

Qualifications:

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.

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