Senior biomedical scientist with 14 years of pharmaceutical industry experience, in both the preclinical and clinical setting, with a focus on discovery and application of biomarkers of safety and efficacy. Served as line function expert on cross-functional project teams as well as extensive experience in leading specialty sub-teams. Excellent analytical, verbal and written communication skills, with extensive experience in analysis of complex data, writing and editing clinical and preclinical documents (clinical protocols, Investigator Brochures, regulatory documents, investigative toxicology reports, external publications). Understanding of FDA, ICH, GLP, GCP and other regulatory guidelines related to drug safety, toxicology, biomarkers and clinical trials. ­-- Molecular biology expertise includes Next Generation Sequencing, Nanostring, Affymetrix microarrays, PCR, Western blots, cell culture, transfection, antibody isolation, immunoprecipitation, immunohistochemistry and fluorescence microscopy -- Computer skills include expert knowledge of Microsoft Office (Word, Excel, PowerPoint), statistical and bioinformatics tools (Partek, SpotFire, GeneSpring, CBioPortal, Ingenuity, MetaCore), literature review tools (PubMed, Ovid) and graphical tools (GraphPad Prism, Adobe Photoshop)

Highlights:

• drug safety
• biomarkers
• clinical research
• clinical trials
• toxicology
• data analysis
• scientific writing