Social network you want to login/join with: Client: Location: Job Category: Other EU work permit required: Yes Job Reference: 19413656334342553633714 Job Views: 2 Posted: 08.05.2025 Job Description: 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. Responsibilities include discussions with global regulators on respiratory clinical development pathways for drug approval facilitation, 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 timely delivery of all 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 process, 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, addressing any data impacting subject safety or study integrity. Attend 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 after unblinding. Support business development for respiratory programs, portfolio, med affairs, and lifecycle management programs. Collaborate with internal stakeholders across departments, participate in ad boards, forums, and meetings, and discuss clinical development pathways with regulators. Develop projects and evaluate new business opportunities or internal drug candidates to expand the respiratory, allergy, and inflammation pipeline, driving strategy from candidate evaluation to registration. Knowledge and Education: Educational Qualifications: MD / MS MD 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 drug development, including regulatory interactions. Knowledge and Skills: Drug Development Scientific advocacy with policymakers/regulators Behavioral Attributes: Strong decision-making and influencing skills. Good interpersonal skills. J-18808-Ljbffr