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. 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, 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 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, addressing or escalating data impacting subject safety or study integrity. Attend internal or joint CRO-sponsor medical monitoring safety meetings and review meeting minutes. Review blinded medical coding for AEs, SAEs, medications, and medical history; participate in BDRM prior to DBL and interpret efficacy and safety post-unblinding. Support business development for respiratory programs, including portfolio management, med affairs, and lifecycle management programs. Collaborate with internal stakeholders across departments and participate in ad boards, respiratory forums, and meetings. Engage with regulators on clinical development pathways and expedite drug approvals. Develop projects and evaluate new business opportunities or internal Target Drug Candidates to expand the respiratory, allergy, and inflammation pipeline. Drive strategy and delivery of respiratory programs from candidate evaluation to registration. Knowledge and Education: Educational Qualifications: MD/MS in Internal Medicine or 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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