Below is a refined version of the original job description with improved formatting, clarity, and focus.
Director/Sr. Director - Clinical Development (Pulmonology), Palermo
Client: [Client details not provided]
Location: Palermo, Italy (or remote within Europe or the US)
Job Category: Other
EU work permit required: Yes
Job Reference: 194136563343425536337141
Job Views: 2
Posted: 08.05.2025
Job Description
Note: The incumbent can be based anywhere in Europe or the US.
Role Overview
This position leads and supports the clinical development of new respiratory drugs, focusing on innovative approaches to planning clinical studies and supporting end-to-end drug development in compliance with all applicable regulations. The role involves discussions with global regulators on respiratory clinical development pathways, 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 start-up and RFP processes, including review of CVs, MMP, and investigator/site lists.
* Provide guidance on subject eligibility, deviations, and protocol-related questions to CROs, site investigators, and study teams.
* Review blinded efficacy and safety data, listings, tables, deviations, and escalate any data impacting subject safety or study integrity.
* Participate in safety meetings and review medical monitoring minutes.
* Review blinded medical coding for adverse events and medical history, and interpret efficacy and safety data post-unblinding.
* Support business development for respiratory programs, including portfolio management and lifecycle strategies.
* Collaborate with internal stakeholders across departments and participate in industry forums and regulatory discussions.
* Drive the development of new projects and evaluate business opportunities to expand the respiratory pipeline, from candidate selection to registration.
Knowledge and Education
Educational Qualifications:
* MD / MS
* Specialization in Internal and Pulmonary/Critical Care Medicine
Experience:
* Minimum 18 years of experience as a pulmonary clinical professional, with at least 5 years in the pharmaceutical industry or clinical project management, including regulatory interactions.
Knowledge and Skills
* Drug Development
* Scientific advocacy with policymakers and regulators
Behavioral Attributes
* Strong decision-making and influencing skills.
* Excellent interpersonal skills.
#J-18808-Ljbffr