lavori da Farmaceutica in località Italia

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Location:

Job Category:

Other

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EU work permit required: Yes

194136563343425536337129

2

08.05.2025

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, including conception of 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 for facilitation of 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 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.
• Review CRO medical monitoring capabilities during study start-up and RFP processes, including CVs, MMP, and investigator/site lists.
• Guide on subject eligibility, deviations, and other medical or safety questions to CRO MM, site investigators, and study teams.
• Review blinded efficacy and safety data, listings, tables, deviations, and support review of SAE or SUSAR related documents, addressing any data impacting subject safety or study integrity.
• Attend internal or joint CRO-sponsor safety meetings and review minutes.
• Review blinded medical coding for AEs, SAEs, medications, and medical history, and interpret efficacy and safety data after unblinding.
• Support business development and portfolio management for respiratory programs, including lifecycle management and new program evaluation.
• 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 / MS
• MD in Internal and Pulmonary/Critical Care Medicine

Experience:

• Minimum 18 years of experience as a pulmonary clinical professional, with over 5 years in the pharmaceutical industry or clinical development projects, including regulatory interactions.

Knowledge and Skills (Functional / Technical):

• Drug Development
• Scientific advocacy with policymakers/regulators

Behavioral Attributes:

• Strong decision-making and influencing skills.
• Good interpersonal skills.