The Clinical Pharmacologist will

• Define and execute clinical pharmacology components of drug development programs, including planning, designing and oversight of studies
• Plan and execute clinical pharmacokinetic and pharmacodynamic analyses to support portfolio projects
• Apply quantitative approaches to develop and implement translational PK/PD strategies, inform dose and dosing regimen selection and support product development decisions.
• Participate on and provide input to project teams
• Contribute to regulatory documents (INDs, clinical trial documents including protocols and study reports, IBs, NDAs)

• PhD (or equivalent), Medical degree, or PharmD
• >3 years experience in pharmaceutical drug development.
• Background in pharmaceutical sciences, pharmacometrics, mathematics, (bio)statistics, biomedical engineering, or a related field.
• Proficiency in R, NONMEM, Phoenix WinNonlin, NLME, Matlab, SAS, or other similar applications
• Experience in performing population PK and PK/PD analyses using pharmacometric software
• Good working knowledge of the drug discovery and development process.
• Scientific understanding of biopharmaceutics, ADME, and clinical pharmacology
• Demonstrated success in executing clinical pharmacology programs and quantitative drug development (population and mechanistic PK/PD modeling and simulations)
• Experience with successful regulatory filings (IND, NDA/BLA, MAA)
• Scientific excellence as demonstrated through track record of publications or presentations in clinical pharmacology and application of quantitative methods in drug development
• Experience in experimental study design, problem solving, critical data analysis and interpretation
• Good written and verbal communication, interdisciplinary collaboration and problem solving skills and ability to work in a fast paced environment