The role can be based at Recordati's European offices in France (Paris or Lyon), 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.
With 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 commercialize 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 PurposeThe Associate Director/Director of Clinical Development will sit within Recordati's recently restructured R&D organization and be an integral part of a team whose mission is to further strengthen the capabilities of R&D here at Recordati.
The role will participate 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.
Main ResponsibilitiesMaintain 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 execution of clinical development plans and 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 for study setup, in accordance with current regulations and laws.Review and recommend amendments to the study protocols, investigator brochure, and Informed Consent Forms to ensure study feasibility.Ensure that the necessary regulatory, safety, and data evaluation requirements are met to allow the conduct of clinical-related activities in conjunction with the regulatory and pharmacovigilance departments.Maintain close relationships/provide clinical and medical support to the clinical operations team to ensure smooth and effective study setup and management.
#J-18808-Ljbffr