Requirements: English
Company: JR Italy
Region: Reggio Emilia , Emilia-Romagna
Job DescriptionNote: Incumbent can be based anywhere in Europe or the US.Role OverviewThis position is intended to lead and support the clinical development of new drugs, focusing on innovative approaches to plan clinical studies and support end-to-end drug development in accordance with all applicable regulations and aligned with the company''s business objectives. Responsibilities include discussions with global regulators on respiratory clinical development pathways to facilitate drug approvals, review and due diligence of in-licensing respiratory molecules, and representation in ad boards and global respiratory meetings.Job ResponsibilitiesLead, manage, and mentor Clinical Sciences respiratory projects, ensuring timely delivery of all deliverables.Contribute to and review key study-related documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.Review CRO medical monitoring capabilities during study startup and RFP processes, including CVs, MMP, and investigator/site lists for vendor selection.Guide on subject eligibility, deviations, and other medical, safety, or protocol questions to CRO medical monitors, site investigators, and study teams.Review blinded efficacy and safety data, listings, tables, deviations, and support review of blinded SAE or SUSAR documents, addressing or escalating data impacting safety or study integrity.Attend internal or joint CRO-sponsor safety meetings and review meeting minutes.Review blinded medical coding for AEs, SAEs, medications, and medical history, and interpret efficacy and safety after unblinding.Support business development for respiratory programs and portfolio, including medical affairs in BD and ROW development, and lifecycle management programs.Collaborate with internal stakeholders across departments and participate in ad boards, respiratory forums, and meetings. Engage with regulators on clinical development pathways and approval processes.Develop projects and evaluate new business opportunities or internal drug candidates to expand the respiratory, allergy, and inflammation pipeline, driving strategy from candidate evaluation to registration.Knowledge and EducationQualifications:MD / MS degreeMD in Internal and Pulmonary/Critical Care MedicineExperience:Minimum of 18 years practicing pulmonary clinical medicine, with over 5 years in the pharmaceutical industry or clinical projects related to drug development and regulatory interactions.Knowledge and SkillsDrug DevelopmentScientific advocacy with policymakers and regulatorsBehavioral AttributesStrong decision-making and influencing skillsGood interpersonal skills#J-18808-Ljbffr