Agnes H. Email and Phone Number

DIRECTOR CLINICAL OPERATIONS I am a seasoned Director, Clinical Operations Leader with extensive experience in clinical development and clinical operations management, from Clinical Pharmacology trials all the way through FDA approval and Post-Marketing Requirements. In 4 months in my previous role, I built a complete Clinical Operation team from the ground up and brought the company to compliance with GDPR regulations prior to starting operations in EU.• FDA BIMO inspection and audit experience (both in War room and as SME).• Perfect track record in Global Clinical Trials management and from first in human Clin Pharm studies, phase I/II to late phases studies, IND, CSR and NDA submission (was granted priority review and Oncology Therapeutic breakthrough designation by FDA)• Over 20 years of experience total in biopharmaceutical companies,• Proficient and certified in US and EU GCP-ICH Guidelines and Regulations• Project Manager Certified and internationally trained with a perfect track record.• MS Project expert level• FDA inspection “War-room” Subject Matter Expert.• Planning and forecasting product development plans and timelines, budget planning and oversight, US and European regulatory submissions to meet US and European regulatory standards.I hold a Clinical Research Management European Degree, a Certification in Design and Interpretation of Clinical Trials from Johns Hopkins, and a Certification in Project Planning and Management from UVA Darden School of Business.