Requirements: English
Company: JR Italy
Region: Terni , Umbria
Social network you want to login/join with:Director/ Sr Director - Clinical Development (Pulmonology), TerniClient:Location:Job Category: Other-EU work permit required: YesJob Reference:194136563343425536337167Job Views:2Posted:08.05.2025Job Description:Note: Incumbent can be based anywhere in Europe or the US.Role Overview:This position is intended to head 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, review & due diligence of in-licensing respiratory molecules, and participation in ad boards and global respiratory meetings.Job Responsibilities:Lead, manage, and mentor Clinical Sciences respiratory projects ensuring timely delivery of all deliverables.Contribute to and review key study 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.Provide guidance on subject eligibility, deviations, and other medical or protocol-related questions to CRO MM, site investigators, and study teams.Review blinded efficacy and safety data, listings, tables, deviations, and support review of SAE or SUSAR documents, addressing data impacting safety or study integrity.Attend internal or joint CRO-sponsor safety meetings and review 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 new and lifecycle management programs.Collaborate with internal stakeholders and participate in ad boards, forums, and meetings; engage with regulators on development pathways and approval processes.Develop projects and evaluate new business opportunities or internal targets for respiratory, allergy, and inflammation pipeline expansion and growth, overseeing strategy and delivery from candidate evaluation to registration.Knowledge and Education:Educational Qualifications:MD / MSMD in Internal and Pulmonary/Critical Care MedicineExperience:Minimum 18 years in pulmonary clinical practice with over 5 years in pharmaceutical/clinical development and regulatory interactions.Knowledge and Skills (Functional / Technical):Drug DevelopmentScientific advocacy with policymakers/regulatorsBehavioral Attributes:Strong decision-making and influencing skills, good interpersonal skills.#J-18808-Ljbffr