Director / Sr Director - Clinical Development (Pulmonology)

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. The role involves discussions with global regulators on respiratory clinical development pathways to facilitate drug approvals, 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 the timely delivery of all project 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 start-up and RFP processes, including CVs, MMP, and investigator/site lists. Provide guidance on subject eligibility, deviations, and other medical, safety, 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 blinded SAE or SUSAR documents, escalating any data impacting safety or study integrity. Participate in medical monitoring safety meetings and review minutes. Review blinded medical coding for AEs, SAEs, medications, and medical history, and interpret efficacy and safety data after unblinding. Support business development for respiratory programs and portfolio, including new and lifecycle management programs. Collaborate with internal stakeholders across various departments. Participate in ad boards, respiratory forums, and presentations at respiratory meetings. Engage with regulators on clinical development pathways to facilitate faster approvals. Evaluate new business opportunities and internal drug candidates for pipeline expansion. Drive the overall strategy and delivery of respiratory programs from candidate evaluation to registration. Knowledge and Education : Educational Qualifications : MD / MS in Internal and Pulmonary / Critical Care Medicine. Experience : Minimum 18 years of experience as a practicing pulmonary clinical professional, with over 5 years in the pharmaceutical industry or clinical projects in clinical development, including regulatory interactions. Knowledge and Skills : Expertise in drug development, scientific advocacy, and regulatory interactions. Behavioral Attributes : Strong decision-making and influencing skills, with good interpersonal abilities. J-18808-Ljbffr

Location: vicenza, IT

Posted Date: 6/14/2025