• Over 30 years of experience in the design and execution of nonclinical pharmacology and toxicology programs and studies in support of clinical drug development and registration• Strategic planning, design, conduct, management and interpretation of preclinical pharmacology, toxicology, DMPK and early clinical POC studies• Direct management of multidisciplinary research teams, vivarium activities and departmental budgets• Project management and coordination across interdisciplinary groups including clinical, regulatory and manufacturing and primary contact with nonclinical CROs• Extensive interaction with FDA from pre-IND through NDA• Writing and editing of critical documents including preclinical reports and summaries in support of INDs, CTDs and NDAs• Preclinical evaluation (scientific and regulatory) of in-licensing product opportunities