Director of Clinical Pharmacology

VirtualVocations
Darnestown, Maryland, United States
Full-time

A company is looking for a Director, Clinical Pharmacology.Key ResponsibilitiesDesign and manage clinical pharmacology components of studies, including PK and PD analysisLead the design of studies to generate PK and PD data, integrating nonclinical and clinical dataAuthor regulatory documents and participate in regulatory interactionsQualificationsPh.

D. or equivalent degree in pharmacokinetics, Pharmacometrics, Pharmaceutical Sciences, or related fieldMinimum of 8+ years of experience in the biopharmaceutical industryStrong knowledge of pharmacokinetic theory and modeling methodsHands-on experience with modeling software such as WinNonlin or NONMEMExperience with regulatory submissions, including INDs and NDAs

4 days ago
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