Pharmaceutical research consultant with extensive scientific and management experience focusing on translational and early clinical development as well as regulatory interactions. Well-respected functional and scientific leader with strong track record of successfully developing drugs in a highly collaborative manner.• Comprehensive and broad knowledge of global drug development with a focus on designing innovative and efficient development strategies for small molecules and biologics. Contributed to strategic drug development decisions as functional area representative to Merck pipeline governance committees at all stages of development, particularly late development. Highly effective direct involvement with development teams as senior management mentor and functional area representative. • Extensive experience in creating and defending clinical pharmacology and biopharmaceutics sections of regulatory filings and labeling for many approved drugs including JANUVIA/JANUMET, ISENTRESS, VICTRELIS, CRIXIVAN, TRUSOPT/COSOPT, PROSCAR, PROPECIA, LIPTRUZET and NOXOFIL. Participated directly and prepared staff for numerous FDA Advisory Committee Meetings, CHMP hearings and PMDA consultations..• Pioneered PK/PD modeling and simulation at Merck and built support with senior management by demonstrating impact on critical program decisions across a range of projects leading to major expansion of Merck’s capability in this area.
Listed skills include Drug Development, Pharmacokinetics, Pharmacodynamics, Predictive Modeling, and 11 others.
