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 aligned with the company's business objectives. Responsibilities include 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 advisory boards and global respiratory meetings.Job Responsibilities:Lead, manage, and mentor Clinical Sciences respiratory projects, ensuring timely delivery of all objectives.Review key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.Assess CRO medical monitoring capabilities during study startup and vendor selection processes.Provide guidance on subject eligibility, deviations, and protocol-related questions to CRO and site staff.Review blinded efficacy and safety data, including listings, tables, deviations, and address any data impacting subject safety or study integrity.Participate in internal and joint CRO-sponsor safety meetings and review minutes.Review blinded medical coding for adverse events and medications, and interpret efficacy and safety data post-unblinding.Support business development for respiratory programs and portfolio management, including lifecycle management programs.Collaborate with internal stakeholders across departments and participate in respiratory forums and meetings.Develop projects and evaluate new business opportunities to expand the respiratory, allergy, and inflammation pipeline, driving strategy from clinical candidate evaluation to registration.Knowledge and Education:Qualifications:MD or MS degreeSpecialization in Internal Medicine and Pulmonary/Critical Care MedicineExperience:Minimum 18 years of experience as a practicing pulmonary clinical professional, with over 5 years in the pharmaceutical industry or clinical development projects, including regulatory interactions.Knowledge and Skills:Drug Development expertiseScientific advocacy with policymakers and regulatorsBehavioral Attributes:Strong decision-making and influencing skillsGood interpersonal skills
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