Director/ Sr Director - Clinical Development (Pulmonology)

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Director/ Sr Director - Clinical Development (Pulmonology), Bolognacol-narrow-left
Client:Location:Job Category:Other
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EU work permit required:Yes
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Job Reference:19413656334342553633713
Job Views:2
Posted:08.05.2025
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Job Description:Note: Incumbent can be based anywhere in Europe or the US.
Role Overview: This position leads and supports the clinical development of new drugs, focusing on innovative approaches to plan clinical studies and support end-to-end drug development in compliance with all applicable regulations, aligning with the company's business objectives.
It 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 advisory boards and global respiratory meetings.
Job Responsibilities: Lead, manage, and mentor Clinical Sciences respiratory projects, ensuring timely delivery of all milestones.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 RFP processes, including review of CVs, MMP, and investigator/site lists.Provide guidance on subject eligibility, deviations, and other medical or protocol-related questions to CRO MM, site investigators, and study teams.Review blinded efficacy and safety data, listings, tables, deviations, and support documentation related to SAE or SUSAR, addressing any data impacting subject safety or study integrity.Participate in internal or joint CRO-sponsor safety meetings and review minutes.Review blinded medical coding for adverse events, SAE, medications, and medical history, and interpret efficacy and safety data post-unblinding.Support business development for respiratory programs, including portfolio management, medical affairs, and lifecycle management.Collaborate closely with internal stakeholders and participate in advisory boards, forums, and regulatory discussions on clinical development pathways.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 pulmonary clinical professional, with over 5 years in the pharmaceutical industry or clinical project management, including regulatory interactions.Knowledge and Skills (Functional / Technical):
Drug DevelopmentScientific advocacy with policymakers/regulatorsBehavioral Attributes:
Decisiveness and influencing skills are essential.
Good interpersonal skills are required.
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