• 20+ years of experience in clinical development, regulatory strategy, and safety surveillance across biotech, pharmaceutical, and medical device sectors
• Previously served as Director of Clinical Research & Safety at Johnson & Johnson and Clinical Research Physician at AstraZeneca
• Led multinational Phase III programs in autoimmune disease (SLE) and cardiovascular indications through successful regulatory milestones including IND, IDE, NDA/BLA submissions, Orphan Drug Designations, and expedited pathways