Requirements: English
Company: Experteer Italy
Region: Milan , Lombardy
Job PurposeThe purpose of the new position is to: Participate in the preparation of the Onco portfolio Clinical Development Plans, based on the strategy agreed with the cross-functional team, and lead consistently the key projects. Establish and maintain excellent partnership with the medical/scientific community and Key Opinion Leaders, as well as with patients associations. Provide medical/clinical support to the Clinical Operation Team in the setup, conduct and finalisation of planned and ongoing trials/clinical development plans. Act as clinical/medical contact for HAs, IRBs, ECs for any aspect related to the implementation and conduct of clinical trials.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. Contribute to the preparation and the 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 to study setup, in accordance to 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 actives in conjunction with the Regulatory and Pharmacovigilance Departments. Maintain close relationship/provide clinical and medical support to Clinical Operation Team to ensure smooth and effective study setup and management. Participate in internal and external clinical meetings, including committee to assess/approve support to investigator-initiated trials, investigators meetings and Advisory Boards, related to assigned clinical studies. Support to Clin Operations to identify high quality investigators and study sites for the conduct of clinical studies. In cooperation with the safety leads, ensure that any important safety issues are discussed and handled with appropriate departments. Work closely with Stats/DM team to ensure Data Analysis and interpretation of data. Prepare and finalise clinical study reports. Prepare the study related communication plans / publications Establish and maintain excellent professional relationships between the company and Key Opinion Leaders (KOL) and the broader medico-scientific community.Required Education Medical Doctor Degree with current medical licensure Board Certification in Oncology will be considered a plusRequired Skills and ExperienceExperience: At least 3 yrs clinical experience with clinical investigator track record At least 5 yrs in the pharmaceutical/biotech industry At least 3 yrs in a clinical development role Experience within onco-hematology/rare diseasesRequired skills: Knowledge of GCP, regulatory interactions, clinical trial methodologies Experience in clinical trial set-up and conduct, including protocol development, review and publication of clinical data, contribution to clinical sections of regulatory documents Ability to interpret and communicate complex clinical and scientific data Advanced communication skills with ability to interact with internal and external stakeholders Ability to manage multiple tasks and respond to rapidly changing prioritiesRequired LanguagesFluency in spoken and written English#LI-AS2#J-18808-Ljbffr