Director/ Sr Director - Clinical Development (Pulmonology)

Social network you want to login/join with:
Director/ Sr Director - Clinical Development (Pulmonology), PordenoneClient: Location: Job Category: Other
-
EU work permit required: Yes
Job Reference:194136563343425536337135
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 designed to lead and support the clinical development of new drugs, focusing on innovative approaches to planning clinical studies and supporting end-to-end drug development in compliance with all applicable regulations and aligned with the company's business objectives.
Responsibilities include engaging with global regulators on respiratory clinical development pathways to facilitate drug approvals, reviewing and conducting due diligence on in-licensing respiratory molecules, and representing the company in advisory boards and global respiratory meetings.
Job Responsibilities: Lead, manage, and mentor Clinical Sciences respiratory projects to ensure timely delivery of all milestones.Contribute to and 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 reviewing CVs, MMP, and investigator/site lists for vendor selection.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 review of blinded SAE or SUSAR documents, escalating any data impacting subject safety or study integrity.Participate in internal or joint CRO-sponsor safety meetings and review meeting minutes.Review blinded medical coding for adverse events and medications, participate in BDRM, and interpret efficacy and safety data after unblinding.Support business development for respiratory programs, including portfolio management, medical affairs, and lifecycle management programs.Collaborate closely with internal stakeholders such as Preclinical Research, Toxicology, DMPK, Regulatory, ClinOps, Project Management, Medical Affairs, and legal teams.
Represent the company in ad boards, respiratory forums, and meetings, and engage with regulators on clinical development pathways.Drive project development and evaluate new business opportunities or internal drug candidates to expand respiratory, allergy, and inflammation pipelines, overseeing strategy and delivery from 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 for drug development.Knowledge and Skills (Functional / Technical): Drug DevelopmentScientific advocacy with policymakers/regulatorsBehavioral Attributes: Strong decision-making and influencing skills, with good interpersonal abilities.
#J-18808-Ljbffr