Clinical Scientist
CurrentProvide scientific support to studies/projects (e.g. phase I, early-stage clinical proof-of-concept and phase III studies in healthy subjects or in patients) during project discussion with sponsors and during project implementation by BlueClinical.Develop study synopsis for phase I, early-stage clinical proof-of-concept and phase III studies, in healthy subjects, or in patients. Develop studies / projects budgets.Conduct preliminary feasibility assessment with KOLs and sites’ clinical study teams.Collect and review scientific information, prepare briefing documents and manage the process of obtaining regulatory and scientific advice from competent regulatory authorities.Liaise with investigators who plan to develop and implement an investigator-initiated study.Coordinate the R&D consultancy services. Liaise with the Medical Management, Medical Writing, Regulatory Affairs and Pharmacokinetics and Pharmacodynamics departments.Keep up with new technologies in drug development (e.g.: antibodies, antibody-drug conjugates, RNA interference, messenger RNA, gene therapy, CRISPR…).Develop and conduct external and internal trainings.Lead the R&D Management team.