Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Venezia; Remoto; EUR 80.000 - 150.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a highly experienced professional to lead clinical development for respiratory projects. This role involves managing clinical studies, collaborating with global regulators, and mentoring teams to ensure timely delivery of key deliverables. The ideal candidate will have extensive experience in pulmonary medicine and drug development, along with strong decision-making and interpersonal skills. Join this innovative firm to drive strategic initiatives in expanding the respiratory and allergy pipeline, contributing to groundbreaking advancements in healthcare.

Competenze

• Minimum 18 years of experience as a practicing pulmonary clinical professional.
• Over 5 years in the pharmaceutical industry or clinical projects in drug development.

Mansioni

• Lead and manage Clinical Sciences respiratory projects with timely deliverables.
• Review key study documents and provide guidance on subject eligibility.
• Collaborate with internal stakeholders and evaluate new business opportunities.

Conoscenze

Drug Development

Scientific advocacy with policymakers/regulators

Decision-making

Interpersonal skills

Formazione

MD / MS

MD in Internal and Pulmonary/Critical Care Medicine

Descrizione del lavoro

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Job Reference:

194136563343425536337111

Job Views:

2

Posted:

08.05.2025

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Job Description:

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

Role Overview:

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 applicable regulations and company objectives. The role involves discussions with global regulators on respiratory clinical development pathways, review and due diligence of in-licensing respiratory molecules, and participation in ad boards and global respiratory meetings.

Job Responsibilities:

1. Lead, manage, and mentor Clinical Sciences respiratory projects, ensuring timely delivery of all deliverables.
2. Contribute to and review key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
3. Review CRO medical monitoring capabilities during study start-up and vendor selection processes.
4. Provide guidance on subject eligibility, deviations, and protocol-related questions to CROs and study teams.
5. Review blinded efficacy and safety data, listings, tables, deviations, and support review of SAE or SUSAR documents.
6. Participate in medical monitoring safety meetings and review minutes.
7. Review blinded medical coding for adverse events and participate in BDRM prior to database lock, providing primary interpretation after unblinding.
8. Support business development for respiratory programs and portfolio management, including new and lifecycle management programs.
9. Collaborate with internal stakeholders across departments and participate in industry forums and meetings.
10. 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 of experience as a practicing pulmonary clinical professional, with over 5 years in the pharmaceutical industry or clinical projects in drug development.

Knowledge and Skills (Functional / Technical):

• Drug Development
• Scientific advocacy with policymakers/regulators

Behavioral Attributes:

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