Roberta Rogowski is a Registered Nurse with over 20 years’ experience in pharmaceutical and biotech as Executive Director of Clinical Operations and Medical Affairs. She has a broad range of clinical experience in both drug and device clinical research, incorporating Phase I, II, III, IIIb and IV clinical trials in adults, geriatrics, pediatric and neonates.  Her experience includes 3 NDA filings in programs she has managed.  Therapeutic areas of expertise include Cardiovascular, Gastroentrology and Central Nervous System.  Roberta spent four years at Neurocrine Biosciences where she served as Executive Director of Clinical Operations , and served in the same role at Somaxon Pharmaceuticals for the five years subsequent to that, from Phase I through and beyond their successful NDA for Silenor®.

 

Roberta’s experience in Clinical Development includes strategic planning for development programs, protocol development, Clinical Operations (timelines, budget, CRO selection, oversight) blinded data review, safety review of clinical adverse events.

 

Medical Affairs responsibilities and experience include development and oversight of specific phase 3b/4 trial strategy, program timelines and budgets, oversight and chairman of the grant committee and the development of Standard Response Letters and FAQs.

 

Roberta's Drug Safety experience includes pharmacovigilance and medical information systems management, Product Inquiry, AE reporting including review of AERs reporting, development of pharmacovigilance plans and QC of SAEs.

 

Roberta started her career as a cardiovascular nurse providing patient care in the intensive care unit and cardiac catheterization laboratory. She began her career in clinical trials as a Research Coordinator for interventional cardiology clinical trials for a group of 12 cardiologists.