Requirements: English
Company: JR Italy
Region: Cagliari , Sardinia
Social network you want to login/join with:col-narrow-leftClient:Location:Job Category:Other-EU work permit required:Yescol-narrow-rightJob Reference:194136563343425536337142Job Views:2Posted:08.05.2025col-wideJob Description:Pls 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 aligning with the company''s business objectives. It involves discussions with global regulators on respiratory clinical development pathways for facilitating drug approvals; review and due diligence of in-licensing respiratory molecules; and presentations in ad boards and global respiratory meetings.Job Responsibilities:Lead, manage, and mentor Clinical Sciences respiratory projects, ensuring timely delivery of all deliverables. Responsibilities may include but are not limited to:Contributing to and reviewing key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.Reviewing CRO medical monitoring capabilities during study start-up and RFP processes, including CVs, MMP, and investigator/site lists for vendor selection.Providing guidance on subject eligibility, deviations, and other medical, safety, or protocol-related questions to CRO MM, site investigators, and study teams.Reviewing blinded efficacy and safety data, listings, tables, deviations, and supporting review of blinded SAE or SUSAR documents, addressing or escalating any data impacting subject safety or study integrity.Attending internal or joint CRO-sponsor safety meetings and reviewing minutes.Reviewing blinded medical coding for AEs, SAEs, medications, and medical history, participating in BDRM, and interpreting efficacy and safety data after unblinding.Supporting business development for respiratory programs, portfolio, and medical affairs, including new and lifecycle management programs.Collaborating with internal stakeholders across research, regulatory, clinical operations, medical affairs, legal, and others. Participating in ad boards, forums, and meetings. Engaging with regulators on clinical development pathways and approval processes.Developing projects and evaluating new business opportunities or internal drug candidates to expand respiratory, allergy, and inflammation pipelines, driving strategy from candidate evaluation to registration.Knowledge and Education:Educational Qualifications:MD / MSMD in Internal and Pulmonary/Critical Care MedicineExperience:Minimum 18 years of experience as a practicing pulmonary clinical professional, with over 5 years in the pharmaceutical industry or clinical development projects, including regulatory interactions.Knowledge and Skills (Functional / Technical):Drug DevelopmentScientific advocacy with policymakers/regulatorsBehavioral Attributes:Strong decision-making and influencing skills. Good interpersonal skills are essential.#J-18808-Ljbffr