Provide PKPD input for regulatory submissions such as briefing documents, IND, CTA and NDA. Contribute to protocol preparation, study execution, data review/analysis, study reports and regulatory document preparation Ph.D. in Pharmacokinetics, Pharmacology, Pharmaceutics or other relevant field with 2-3 years' experience in pharmaceutical industry, or M.D or Pharm.D. with equivalent experience. Level and responsibilities will depend on the individual's experience and interpersonal skills. Strong knowledge of clinical pharmacology principles in drug development including PKPD, modeling and simulation, ADME concepts, and clinical pharmacology. Hand-on experience in using R and other data visualization techniques for representation of PKPD data. Proficient in using Phoenix WinNonlin, Phoenix NLME, R, NONMEM, or other pharmacokinetic, modeling software. Training in application of pharmacometric principles or software would be a plus. Strong communication skills (verbal and written) and presentation skills are required. Excellent interpersonal and collaboration skills and the ability to function in a highly matrixed team environment are essential.
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