Over 20 years of technical leadership in strategic development and management of preclinical and clinical programs of small molecules in multiple therapeutic areas; in-depth knowledge of drug development, clinical and non-clinical pharmacokinetics (PK), pharmacodynamics (PD), biopharmaceutics and drug-drug interaction studies; good understanding of metabolism (CYPs), transporters, pharmacology and toxicology principles; an expert in the design and execution of clinical pharmacology and non-clinical studies across multiple therapeutic programs; an expert in writing regulatory documents, including non-clinical and clinical study reports in support of IB, IND and NDA/MAA applications; PK modeling/simulation and human PK predictions experience; proficient use of WinNonlin/Phoenix, Sigma Plot, and Microsoft Office software; extensive experience in project management, outsourcing and CRO monitoring, working knowledge of GXPs, SOPs, ICH/FDA regulations, bioanalytical (LC-MS) and contract negotiation; excellent knowledge in regulatory affairs and representation for discussion with various agencies in the world, contribution to regulatory IND, NDA, MAA electronic submissions in the US and Europe, and contribution to FDA advisory meetings; strong leadership and teamwork attributes; excellent effective time management, outsourcing, and scientific writing skills.