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, including conception of innovative approaches to plan clinical studies and support end-to-end drug development in accordance with all applicable regulations and aligning them with the company's business objectives. The role 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 to ensure 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 start-up and RFP process, including CVs, MMP, and investigator/site lists for vendor selection. 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, addressing or escalating data impacting safety or study integrity. Attend internal or joint CRO-sponsor medical monitoring safety meetings and review medical meeting 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. Build and maintain collaboration with internal stakeholders across various departments. Participate in ad boards, respiratory forums, and meetings, and engage with regulators on clinical development pathways. Develop projects and evaluate new business opportunities or internal Target Drug Candidates for pipeline expansion. Drive the overall strategy and delivery of respiratory programs from candidate evaluation through 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 with policymakers/regulators. Behavioral Attributes : Good decision-making and influencing skills, strong interpersonal skills. J-18808-Ljbffr

Location: rimini, IT

Posted Date: 6/14/2025