Director/ Sr Director - Clinical Development (Pulmonology)

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 and contribute to key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.Assess CRO medical monitoring capabilities during study start-up 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, listings, tables, deviations, and support safety-related document reviews.Participate in medical monitoring safety meetings and review meeting minutes.Review blinded medical coding for adverse events and medications, participate in BDRM, and interpret efficacy and safety data post-unblinding.Support business development for respiratory programs, portfolio, and lifecycle management.Collaborate with internal stakeholders across departments and participate in industry 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:Educational Qualifications: MD / MSMD in Internal 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 project management, including regulatory interactions.Knowledge and Skills:Drug DevelopmentScientific advocacy with policymakers/regulatorsBehavioral Attributes:Strong decision-making and influencing skills.Excellent interpersonal skills.
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