Director/ Sr Director - Clinical Development (Pulmonology)

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Director/ Sr Director - Clinical Development (Pulmonology), Mantova-
Client:Location:Job Category:Other
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EU work permit required:Yes
Job Reference:194136563343425536337124
Job Views:2
Posted:08.05.2025
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, involving 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, review & 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 to ensure timely delivery of all objectives.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 or protocol-related questions.Review blinded efficacy and safety data, listings, tables, deviations, and support review of SAE or SUSAR documents.Attend internal or joint CRO-sponsor safety meetings and review minutes.Review blinded medical coding for AEs, SAEs, medications, and medical history, participating in BDRM prior to DBL and interpreting efficacy and safety after unblinding.Support business development for respiratory programs and portfolio management, including new and lifecycle management programs.Collaborate with internal stakeholders across departments and participate in ad boards, forums, and meetings with regulators.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 projects in drug development, including regulatory interactions.Knowledge and Skills:
Drug DevelopmentScientific advocacy with policymakers/regulatorsBehavioral Attributes:
Strong decision-making and influencing skills.Good interpersonal skills.
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