lavori in località Bari (Italia)

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Note: Incumbent can be based anywhere in Europe or the US.

This position is responsible for leading and supporting the clinical development of new drugs, including planning clinical studies and supporting end-to-end drug development in accordance with all applicable regulations and company objectives. The role involves discussions with global regulators on respiratory clinical development pathways for drug approvals, reviewing in-licensing respiratory molecules, and participating in global respiratory meetings.

• 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 vendor selection processes.
• Provide guidance on subject eligibility, deviations, and protocol-related questions to CRO and site teams.
• Review blinded efficacy and safety data, and support safety monitoring and data integrity.
• Participate in medical monitoring safety meetings and review related documentation.
• Support business development and portfolio management for respiratory programs, including lifecycle management.
• Collaborate with internal stakeholders across departments and participate in industry forums and meetings.
• Evaluate new business opportunities and drive strategy from clinical candidate evaluation to registration.

Qualifications:

• MD / MS, with specialization in Internal Medicine and Pulmonary/Critical Care Medicine.

Experience:

• Minimum of 18 years of clinical pulmonary practice, including at least 5 years in pharmaceutical or clinical development projects, with regulatory interaction experience.

Skills:

• Drug development expertise.
• Scientific advocacy and regulatory engagement skills.

Behavioral Attributes

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