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 and 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 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 processes, 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 medical monitors, site investigators, and study teams. Review blinded efficacy and safety data, listings, tables, deviations, and support review of blinded SAE or SUSAR documents, addressing any data impacting subject safety or study integrity. Participate in internal or joint CRO-sponsor medical monitoring safety meetings and review minutes. Review blinded medical coding for AEs, SAEs, medications, and medical history, and interpret efficacy and safety data post-unblinding. Support business development activities for respiratory programs and portfolio, including new and lifecycle management programs. Build and maintain collaboration with internal stakeholders such as Preclinical Research, Toxicology, DMPK, Regulatory, ClinOps, Project Management, Medical Affairs, and Legal. Participate in ad boards, respiratory forums, and meetings, and engage in discussions with regulators on clinical development pathways for faster approvals. Evaluate new business opportunities or internal Target Drug Candidates to expand the respiratory, allergy, and inflammation pipeline. Drive the overall strategy and delivery of respiratory programs from candidate evaluation to registration. Knowledge and Education : Educational Qualifications : MD / MS, preferably in Internal Medicine and Pulmonary / Critical Care Medicine. Experience : Minimum 18 years as a practicing pulmonary clinical professional with over 5 years in the pharmaceutical industry or clinical project management, including regulatory interactions for drug development. 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