Director of Clinical Operations at Antibe Therapeutics Inc., a biotechnology company developing next generation of safer therapies for pain and inflammation, based in Toronto, Canada.
• Global clinical development professional with over 15 years of experience in clinical research organizations across a variety of therapeutic areas, including Oncology, CNS, Respiratory, Hematology, General Medicine and Rare diseases.
• Phases: I-IV, Early access
• Regions: EMEA, Asia, Africa and North America.
• Experienced in demanding clinical study environments, focused on projects and programs deliverables through active risk management and problem solving, ensuring operational and financial project excellence.
• Oversight and management experience of various vendors including CROs, Central Laboratories, Home Health Nursing providers, Drug suppliers, ECG and Central imaging companies as well as functional departments such as Clinical Monitoring, Regulatory, Start Up, Feasibility, Medical, Pharmacovigilance, Data Management, Biostats and Programming, Finance, Legal and QA.
• Consultant on topics such as clinical development and operations, monitoring, decentralized trials, regulatory, start up, feasibility, legal, PVG and QA.