Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Treviso; In loco; EUR 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a Director/Sr Director for Clinical Development specializing in Pulmonology. This pivotal role involves leading innovative clinical studies and engaging with global regulators to facilitate drug approvals. The ideal candidate will possess extensive experience in pulmonary medicine and drug development, with a strong focus on strategic collaboration across departments. If you are passionate about advancing respiratory health and have a proven track record in clinical projects, this opportunity offers a chance to significantly impact the future of drug development in a dynamic environment.

Competenze

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

Mansioni

• Lead and manage Clinical Sciences respiratory projects for timely delivery.
• Review key study documents and provide guidance on subject eligibility.
• Collaborate with internal stakeholders and engage with regulators.

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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Director/ Sr Director - Clinical Development (Pulmonology), Treviso

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Job Reference:

194136563343425536337115

Job Views:

2

Posted:

08.05.2025

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Job Description:

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 aligned with the company's business objectives. The role involves discussions with global regulators on respiratory clinical development pathways to facilitate drug approvals, 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 to ensure timely delivery of all objectives.
2. Review and contribute to 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 RFP processes, including CVs, MMP, and investigator/site lists for vendor selection.
4. Provide guidance on subject eligibility, deviations, and protocol-related questions to CRO MM, site investigators, and study teams.
5. Review blinded efficacy and safety data, listings, tables, deviations, and provide support for blinded SAE or SUSAR documents, addressing any data impacting subject safety or study integrity.
6. Participate in internal or joint CRO-sponsor safety meetings and review meeting minutes.
7. Review blinded medical coding for AEs, SAEs, medications, and medical history, and interpret efficacy and safety data post-unblinding.
8. Support business development for respiratory programs, portfolio, and medical affairs in BD and ROW development, including lifecycle management programs.
9. Collaborate with internal stakeholders across departments and participate in ad boards, forums, and meetings. Engage with regulators on development pathways and approval processes.
10. Develop projects and evaluate new business opportunities or internal candidates 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 practicing pulmonary clinical professional, with over 5 years in the pharmaceutical industry or clinical projects related to clinical development and 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.