* Early-stage pharmaceutical development subject matter expert ranging from nonclinical safety and efficacy through to human Clinical Pharmacology and Proof of Concept trials* Thrives in the fast-paced, high impact roles of small and large companies.* Excels in multitasking, communication, personnel management and team development. * Extremely detail oriented, enthusiastic, and professional.* Experienced in a variety of indications including infectious disease, inflammation, cardiovascular, oncology, women's health and sexual dysfunction.* Accomplished in regulatory affairs and FDA interactions on the topics of nonclinical pharmacology/toxicology, biopharmaceutics, and clinical pharmacology.Specialties: Preclinical and nonclinical development of small molecule, peptide, and biologic compounds. Preclinical development from drug candidate selection to first-in-man IND-enabling studies to support for later-stage clinical development through to the completion of NDA/BLA-enabling preclinical safety assessment package, including preparing regulatory submissions. Animal efficacy studies to support mechanism of action and proof-of-principle as well as medical countermeasure approved under FDA's "Animal Rule."
Listed skills include Drug Discovery, Drug Development, Biotechnology, Pharmaceutical Industry, and 31 others.