Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Pescara; Remoto; EUR 90.000 - 150.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a Director/Sr Director of Clinical Development specializing in Pulmonology. This pivotal role involves leading clinical projects, ensuring compliance with regulations, and collaborating with global regulators to facilitate drug approvals. The ideal candidate will have extensive experience in pulmonary medicine and drug development, with a strong focus on innovative approaches to clinical studies. Join a forward-thinking team dedicated to advancing respiratory health and making impactful contributions to drug development strategies.

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 mentor Clinical Sciences respiratory projects ensuring timely delivery.
• Review key study documents including protocols and informed consents.
• Collaborate with internal stakeholders and participate in regulatory discussions.

Conoscenze

Drug Development

Scientific advocacy with policymakers/regulators

Strong decision-making

Good 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), Pescara

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EU work permit required:

Yes

Job Reference:

194136563343425536337143

Job Views:

2

Posted:

08.05.2025

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. It 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, 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 RFP processes, including CVs, MMP, and investigator/site lists.
4. Provide guidance on subject eligibility, deviations, and other medical, safety, or protocol-related questions to CRO medical monitors, site investigators, and study teams.
5. 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.
6. Attend internal or joint CRO-sponsor safety meetings and review 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, including new and lifecycle management programs.
9. Collaborate with internal stakeholders and participate in ad boards, forums, and meetings, including discussions with regulators on clinical development pathways.
10. Develop projects and evaluate new business opportunities or internal drug candidates to expand respiratory, allergy, and inflammation pipelines, driving strategy and delivery 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, including regulatory interactions.

Knowledge and Skills:

• Drug Development
• Scientific advocacy with policymakers/regulators

Behavioral Attributes:

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