Leo James

Dr Leo James obtained degrees in Medicine and Biochemistry from the University of Edinburgh. He practised general medicine in various Scottish hospitals before joining the pharmaceutical industry in 2002. His first role was as a clinical research physician in an early-phase trials unit, serving as the study physician on more than 40 Phase 1 and Phase II studies including first in man, single and multiple ascending dose, food effect, drug-drug interaction, bioequivalence, phototoxicity, pain models, anaesthesia, medical devices and radiolabelled compounds. He was also Principal Investigator or Co-Principal Investigator on more than 15 Phase 1 studies.

In 2007, Leo joined ProStrakan, a small Scottish pharmaceutical company, initially working on pivotal phase III studies in gastroenterology and endocrine. After 18 months, he was promoted to UK Medical Director with responsibility for products in bone disease, cardiovascular, endocrinology, gastrointestinal, infectious disease, oncology, pain, postoperative care and urology across the UK, Europe and the US. The role included medical leadership of two product launches, marketing authorisation applications, license renewals, product labelling, due diligence for in-licensing, ABPI Code compliance, pharmacovigilance, risk assessments for product quality issues and medical information.

In 2011, Leo joined the late-phase clinical trials group at Astellas Pharma Europe, rising to Senior Director, Medical Science. This was a leadership role with significant responsibility for the scientific quality, execution, analysis and reporting of all Astellas late-phase clinical trials in Europe across oncology, urology, anti-infectives, transplant and pain. Leo served as the Chair of the European scientific committee and led the oversight of 100+ Astellas late-phase studies and 150+ Investigator-Sponsored Research studies. During this time he built a highly successful team of clinical research physicians and statisticians to support Astellas’ late-phase trials. Leo received several awards from Astellas, in particular recognising his role in the development and implementation of improved processes for clinical trial data management and trial safety monitoring.

In 2017, he left Astellas to found Dr Leo James Ltd, providing expert medical leadership and support to a variety of clients including start-ups, CROs and top 5 pharma to CMO/Medical Director level in clinical trials, data analysis, regulatory and commercial strategy.

Leo has been an expert member of the Berkshire B Research Ethics Committee since mid-2018 and an expert member of the UK Specialist ad hoc Ethics Committee for COVID challenge studies since October 2020. He has been registered with the Faculty of Pharmaceutical Medicine as an Educational Supervisor for Pharmaceutical Medicine Specialist Training since 2014.