Below is a refined version of the original job description with improved formatting, clarity, and focus.Director/Sr. Director - Clinical Development (Pulmonology), PalermoClient: (Client details not provided)Location: Palermo, Italy (or remote within Europe or the US)Job Category: OtherEU work permit required: YesJob Reference: 194136563343425536337141Job Views: 2Posted: 08.05.2025Job DescriptionNote: The incumbent can be based anywhere in Europe or the US.Role OverviewThis position leads and supports the clinical development of new respiratory drugs, focusing on innovative approaches to planning clinical studies and supporting end-to-end drug development in compliance with all applicable regulations. The role involves discussions with global regulators on respiratory clinical development pathways, review and due diligence of in-licensing respiratory molecules, and participation in advisory boards and global respiratory meetings.Job ResponsibilitiesLead, manage, and mentor clinical sciences respiratory projects, ensuring timely delivery of all milestones.Review key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.Assess CRO medical monitoring capabilities during study start-up and RFP processes, including review of CVs, MMP, and investigator/site lists.Provide guidance on subject eligibility, deviations, and protocol-related questions to CROs, site investigators, and study teams.Review blinded efficacy and safety data, listings, tables, deviations, and escalate any data impacting subject safety or study integrity.Participate in safety meetings and review medical monitoring minutes.Review blinded medical coding for adverse events and medical history, and interpret efficacy and safety data post-unblinding.Support business development for respiratory programs, including portfolio management and lifecycle strategies.Collaborate with internal stakeholders across departments and participate in industry forums and regulatory discussions.Drive the development of new projects and evaluate business opportunities to expand the respiratory pipeline, from candidate selection to registration.Knowledge and EducationEducational Qualifications:MD / MSSpecialization in Internal and Pulmonary/Critical Care MedicineExperience:Minimum 18 years of experience as a pulmonary clinical professional, with at least 5 years in the pharmaceutical industry or clinical project management, including regulatory interactions.Knowledge and SkillsDrug DevelopmentScientific advocacy with policymakers and regulatorsBehavioral AttributesStrong decision-making and influencing skills.Excellent interpersonal skills.
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