Director, Clinical Management and Pharmacokinetics
Senior Clinical Pharmacologist and Pharmacokineticist, clinical trial lead and project manager with extensive leadership experience, shepherding projects from initial discovery stage to submission of IND, ANDA (505j) and NDA (505b2) in premier global organizations. Established track record in innovative design and execution of BE/BA (505j), PK/PD (phase I/II), and clinical endpoint equivalence studies (Phase III) at external CROs according to FDA/regulatory requirements, within budget and on time. Experience in providing due diligence on selection of in-license products from other business development partners. Managing multiple R&D projects and simultaneously expediting and successfully advancing programs from concept to completion. Strong managerial and scientific background involved PK/PD, ADME and project management for pre-clinical and clinical studies. Authored and co-authored many publications and presentations. Specialties: Subject matter expert in DMPK, PK/PD Pre-clinical and Clinical studies for small molecules and biologics (Antibody Drug Conjugates), Biopharmaceutics, Bioanalytical, Pre-clinical and Clinical study conductance and design, monitoring of clinical studies, IND/NDA/ANDA writing & submission, strong communicator, team leader and project manager. Strong publications record.