Over 20 years experience as Manager of Phase I-IV clinical trials supporting submission and approval of 2 NDAs, as well as line management and oversight of cross-functional study execution teams.Coordination and oversight of cross-functional and multidisciplinary project teams to ensure rapid study start-up, enrollment, study processing, and closeout through CSR.Lead Project Manager on:Phase I (bioequivalence, FIH (SAD/MAD), FE, DDI, C14)Phase II (dose-finding, proof of concept, multicenter)Phase III (pivotal multicenter), 1000+ patientsPhase IV (FDA post-marketing commitment)Key therapeutic indications include: • Urology - Overactive Bladder, Premature Ejaculation• Neurology/CNS - Stuttering, Narcolepsy, Pain, Adrenoleukodystrophy, Spinal Cord Injury• Cardiovascular: Hypertension• Dermatology: Atopic Dermatitis• Immunology/Allergy: Hereditary angioedema• Endocrinology - Diabetes, Gestational Diabetes, Low Testosterone, Central Precocious Puberty (implant), GnRH deficiency (Idiopathic Hypogonadotropic Hypogonadism)• Nephrology - Chronic Kidney Disease/Diabetic Nephropathy• Oncology - Bladder Cancer, Prostate Cancer (implant), Osteosarcoma/solid tumor• Ophthalmology - Open Angle Glaucoma/Ocular Hypertension• Abuse Potential - Opiate Addiction (implant)• Hematologic – Anemia• Respiratory – Cystic Fibrosis, Idiopathic Pulmonary Fibrosis, COVID-19• Gynecological – Uterine Fibroid• Maternal Fetal Medicine – Gestational Diabetes Mellitus (in vitro diagnostic)