With over 25 years of experience in clinical development, I am a Clinical Scientist and Clinical Operations Expert with extensive experience working with biotechs, pharmaceuticals, Contract Research Organizations (CROs), and AI digital-biotech companies.My expertise spans multiple therapeutic areas, including neuropsychology, cardiovascular, oncology, and rare diseases particularly in Phase 2a, b, 3 and morbi-mortality studies. I manage clinical trials from study setup to regulatory submission, focusing on medical and operational oversight and maintaining strong peer-to-peer relationships with key medical experts and medical affairs.I have a strong background in Clinical Sciences and Operations including Medical Data Review and Safety Management, data-driven optimisation of patient selection and endpoint criteria, study budget forecasting, RFP management, CRO and Vendors selection and oversight, Clinical Development process optimisation.My work involves extensive cross-functional collaboration with executives, key opinion leaders (KOLs), and scientific advisory board members to align clinical strategies with organizational goals.As a Clinical Scientist and Clinical Operations contractor since 2016, I have led projects to refine clinical operations processes and provide strategic guidance on outsourcing strategies. I have developed a robust methodology and online tool for outsourced study budget forecasting. I have supported early-stage biotech companies in optimizing clinical trial design using open-source databases and have integrated machine learning (ML) and artificial intelligence (AI) into drug development, enhancing innovation through data-driven approaches.I am passionate about de-risking and optimizing clinical trial processes to ensure positive study outcomes and patient safety, with optimal budget clarity and control.