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 aligned with the company's business objectives. Responsibilities include discussions with global regulators on respiratory clinical development pathways for facilitating drug approvals; review & 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. Review and contribute to key study documents such as protocols, informed consents and 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 subject safety or study integrity. Attend internal or joint CRO-sponsor safety meetings and review medical meeting minutes. Review blinded medical coding for AEs, SAEs, medications, and medical history, participating in BDRM and providing primary interpretation post-unblinding. Support business development for respiratory programs, portfolio, and medical affairs in BD and ROW development, including lifecycle management programs. Build and maintain collaboration with internal stakeholders across various departments. Participate in ad boards, respiratory forums, and meetings; engage with regulators on clinical development pathways. Develop projects and evaluate new business opportunities or internal Target Drug Candidates to expand the respiratory, allergy, and inflammation pipeline. Drive the 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 as a practicing pulmonary clinical professional with over 5 years in the pharmaceutical industry or clinical project management, including regulatory interactions. Knowledge and Skills : Expertise in drug development, scientific advocacy, and regulatory engagement. Behavioral Attributes : Strong decision-making and influencing skills, with good interpersonal abilities.
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