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Director / Senior Director, Clinical Development | (Up-242)
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Director Of Clinical Development
hace 3 meses
.Territory:Shift: Full TimeSeniority: DirectorWith its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical force, listed on the Italian stock exchange, with over 4,300 employees.We are a group of like-minded, passionate individuals who go to extraordinary lengths for our partners, customers, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries.At Recordati, our mantra is simple. We've always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest – we want to give people the opportunity to be the best version of themselves.This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases.Recordati. Unlocking the full potential of life.Job Purpose The Director of Clinical Development will sit within Recordati's recently restructured R&D organisation and will be an integral part of a team whose mission is to further strengthen our global R&D capabilities.The role will participate 'hands-on' in the preparation of the oncology portfolio clinical development plans, based on the strategy agreed with the cross-functional team, and lead several key projects. The Director of Clinical Development will establish and maintain excellent partnerships with the medical/scientific community and key opinion leaders (KOLs), as well as with patient's associations and provide medical/clinical support to the clinical operation team for the setup, conduct and finalisation of planned and ongoing trials/clinical development plans. The role will act as clinical/medical contact for HAs, IRBs, ECs for any aspect related to the implementation and conduct of clinical trials.The role can be based at Recordati's offices in the US (NJ), UK (Hemel Hempstead), Italy (Milan), Spain (Madrid) or Germany (Ulm) and will involve international travel. We offer hybrid working with a minimum of 2 days per week in the office.Key Responsibilities Maintain engagement across the global landscape with all potential investigators to identify appropriate clinical trial programs and supervise investigator-initiated trials to data portfolio.Lead the preparation and the execution of clinical development plans at phase I, II and III including regulatory interactions, and of the study protocols, in line with company strategies and objectives.Act as primary contact for any study related medical/clinical questions and manage the preparation of responses to clinical related FDA, EMA and other regulatory authorities' requests.Prepare and/or supervise the preparation of all clinical documents necessary to study setup, in accordance to current regulations and laws
