Jobs in Treviso, United States

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194136563343425536337125

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08.05.2025

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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, focusing on innovative approaches to plan clinical studies and support end-to-end drug development in accordance with all applicable regulations and aligning with the company's business objectives. It involves discussions with global regulators on respiratory clinical development pathways for facilitating 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 milestones.
• Review and contribute to 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 for vendor selection.
• 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.
• Participate in internal or joint CRO-sponsor safety meetings and review minutes.
• Review medical coding for AEs, SAEs, medications, and medical history, and interpret efficacy and safety data post-unblinding.
• Support business development for respiratory programs and portfolio, including new and lifecycle management programs.
• Collaborate with internal stakeholders across departments and participate in ad boards, respiratory forums, and meetings.
• Engage with regulators on clinical development pathways and approval processes.
• Develop projects and evaluate new business opportunities to expand the respiratory, allergy, and inflammation pipeline, driving strategy from candidate evaluation to registration.

Knowledge and Education:

Educational Qualifications:

• MD / MS
• MD in Internal and Pulmonary/Critical Care Medicine

Experience:

• Minimum 18 years in pulmonary clinical practice with over 5 years in pharmaceutical or clinical development projects, including regulatory interactions.

Knowledge and Skills (Technical):

• Drug Development
• Scientific advocacy with policymakers/regulators

Behavioral Attributes:

• Decision-making and influencing skills
• Good interpersonal skills