Assist biotech companies in designing comprehensive clinical development plans

Led medical organization including clinical development, clinical operations, biometrics, regulatory affairs, pharmacovigilance, and medical affairs. Built group from 4 individuals to over 70 and brought 3 rare renal disease programs into the clinic, including a global Phase 3 clinical trial over a 2 year period.

Chief Medical Officer for Biotech with clinical stage assets in inflammation, metabolic disorders, and non-alcoholic fatty liver disease

Head of Clinical Development and responsible for a diverse portfolio of clinical programs including those in Pulmonary Hypertension, Immunology, Inflammatory Bowel Diseases(Crohn's Disease and Ulcerative Colitis), Smoking Cessation. Obesity, Acute Coronary Syndrome, pain management, and fibrotic diseases. Also responsible for clinical planning for pre-clinical assets in multiple therapeutic areas. Responsible for Clinical Development, Medical Affairs, Clinical Operations, Biostatistics, and Data Management functional areas

Vice President Clinical AffairsLed Clinical Development turn-around effort for financially troubled Biotech Company based in New Jersey, focused on orphan drugs in immunology therapeutic area.• Revised clinical development plan to meet EMA and FDA Post-Marketing Commitments and Post-Authorisation Measures, reducing costs and increasing usefulness of potential clinical data as part of ongoing negotiations with regulatory agencies• Reduced cost of ongoing clinical trial program by approximately 50% by moving some work in-house and aggressively discontinuing unproductive study recruitment efforts• Responsible for clinical development, pharmacovigilance, clinical operations, biostatistics, non-clinical development, and medical writing functions utilizing both internal resources and external contractors and consultants• Assessment of post-marketing drug safety data• Drive Phase 3b/4 clinical development program for KRSTEXXA in gout• Oversight of US and EU post-marketing commitments including 2 observational clinical trials, and multiple interventional clinical trials• Clinical leader for regulatory submissions, including rapporteur meetings, and FDA meetings preparation• Leader for global pharmacovigilance• Clinical leader responsible for due diligence of in-licensing opportunities

Senior Medical Director - Clinical ScienceNephrology:• Drive program to prevent progression of chronic kidney disease and direct 15-person team for AST-120 Phase 3 clinical outcomes program comprised of 2000 patients and a $150 Million operational budget. Develop plan to demonstrate that AST-120 may reduce cardiovascular events in chronic kidney disease.• Appointed to lead clinical organization for steering committee, data monitoring committee and clinical trial program data presentations at national meetings. Lead teams responsible for writing Summary of Clinical Efficacy and Summary of Clinical Pharmacology for NDA. • Increased accountability of CRO to improve study quality and reduce costs by moving study work in-house or to CROs as needed. Instituted change order review processes that enabled significant cost reductions • Increased MTDAs visibility in scientific community by presenting data at major scientific meetings.Diabetes:• Design Phase 2 glucokinase activator clinical program in diabetes encompassing 200 patients in the US with a team of five professionals

Diabetes/Obesity:• Led clinical team for CB-1 antagonist program in Obesity/diabetes prior to its termination. Cardiovascular Diseases:• Served as the Cardiovascular Development Team leader for the thirteen-person, cross functional Atrial Fibrillation early development team with two compounds in Phase 1/Phase 2 trials.- Supervised 12-member cross-functional development team and two direct reports to perform clinical development, pre-clinical research, toxicology, pharmacokinetics, CMC, marketing and regulatory requirements.- Contributed as a member of Joint Development Committee with Japanese development partner.- Managed team in Pre-NDA meeting for NTC-801 and successfully negotiated on important clinical trial issues.• Performed due diligence on in-licensing for CV arrhythmia compounds . Received the Galaxy Award for role in in-licensing NTC-801 Acute MI/Reperfusion injury• Directed cross functional clinical development team as Medical Lead for KAI 9803 program to prevent reperfusion injury in acute MI, a planned Phase 3 program.- Developed Phase 3 Plan for KAI 9803 with outside KOLs, which would was to be largest clinical outcomes trial of a drug therapy in acute MI in history.Transplantation:• Led Belatacept CV and Metabolic Issues team for Belatacept (anti-rejection drug in kidney transplant) FDA Advisory Committee meeting• Performed BLA/Advisory Committee preparation and received Triumph BDOC Award for Ad Com work.• Spearheaded the writing of CV and Metabolic section of Summary of Clinical Efficacy (SCE) for BLA.Rheumatoid arthritis:• Led Summary of Clinical Safety (SCS) team for Abatacept-SQ BLA, compound which handled clinical, biostatistics, labeling, and medical writing projects in preparation of SCS document for regulatory filings

• Served as the Medical Monitor for two Phase 3 obesity treatment trials, Phase 2 obesity treatment in diabetic subjects trial and Phase 1 obesity drug pharmacokinetic study.• Contributed as a Strategic Planning Team Member to organize expert panel for obesity and diabetes topics.• Provided clinical input for development of product profiles for market research.• Developed the plan and served as medical monitor for the Axokine obesity and diabetes programs, including protocols, CSRs, ad board management and enrollment enhancement. • Presented at and wrote abstract for Phase 2b data at National Obesity Data Meetings.