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Director/ Sr Director - Clinical Development (Respiratory), lucca
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Location:
Job Category:
Other
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EU work permit required:
Yes
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Job Reference:
7450231472016850944337146
Job Views:
1
Posted:
02.05.2025
Expiry Date:
16.06.2025
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Job Description:
Pls 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, conceive innovative approaches to plan clinical studies, and support end-to-end drug development in accordance with all applicable regulations and align them with the company's business objectives. It involves discussions with global regulators on respiratory clinical development pathways for drug approvals, 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 ensuring timely delivery of all deliverables.
* Review and contribute to key study-related documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
* Review CRO medical monitoring capabilities during study start-up and RFP process, including CVs, MMP, and investigator/site lists.
* Provide guidance on subject eligibility, deviations, and other medical or safety-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, addressing any data impacting subject safety or study integrity.
* Attend internal or joint CRO-sponsor medical monitoring safety meetings and review meeting minutes.
* Review blinded medical coding for AEs, SAEs, medications, and medical history, and interpret efficacy and safety data after unblinding.
* Support business development for respiratory programs, portfolio, and medical affairs in BD and ROW development, including new and lifecycle management programs.
* Collaborate with internal stakeholders across departments and participate in ad boards, respiratory forums, and meetings, engaging with regulators on clinical development pathways.
* Develop projects and evaluate new business opportunities or internal drug candidates to expand the respiratory, allergy, and inflammation pipeline, driving strategy from candidate evaluation to registration.
Knowledge and Education:
Educational Qualifications:
* MD / MS
* MD Internal and Pulmonary/Critical Care Medicine
Experience:
* 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 (Functional / Technical):
* Drug Development
* Scientific advocacy with policymakers/regulators
Behavioral Attributes:
* Decision-making and influencing skills, good interpersonal skills are essential.
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