Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Salerno; In loco; EUR 80.000 - 150.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a Director/Sr Director for Clinical Development in Pulmonology. This pivotal role involves leading innovative clinical studies and engaging with global regulators to facilitate drug approvals. With a focus on respiratory health, you will manage clinical projects, mentor teams, and drive business development initiatives. The ideal candidate will possess extensive experience in pulmonary clinical practice and a strong background in the pharmaceutical industry. Join a forward-thinking company dedicated to advancing healthcare solutions and making a significant impact in the field.

Competenze

• 18+ years in pulmonary clinical practice with 5+ years in clinical development.
• Experience in regulatory interactions and drug development processes.

Mansioni

• Lead and manage Clinical Sciences respiratory projects.
• Review key study documents and provide guidance on subject eligibility.
• Collaborate with internal stakeholders and support business development.

Conoscenze

Drug Development

Scientific advocacy with policymakers/regulators

Decision-making and influencing skills

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), Salerno

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EU work permit required:

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Job Reference:

194136563343425536337149

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 aligning with the company's business objectives. Responsibilities include discussions with global regulators on respiratory clinical development pathways for facilitating drug approvals, review and due diligence of in-licensing respiratory molecules, and presentations at 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 or safety questions to CRO MM, 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 safety or study integrity.
6. Attend internal or joint medical monitoring safety meetings and review minutes.
7. Review medical coding for AEs, SAEs, medications, and medical history, and interpret efficacy and safety data post-unblinding.
8. Support business development for respiratory programs and portfolio, including new and lifecycle management programs.
9. Collaborate with internal stakeholders across departments and participate in ad boards, forums, and meetings.
10. Develop projects and evaluate new business opportunities or internal drug candidates for pipeline expansion.

Knowledge and Education:

Educational Qualifications:

• MD / MS
• MD in Internal and Pulmonary/Critical Care Medicine

Experience:

• Minimum 18 years in pulmonary clinical practice with over 5 years in pharmaceutical industry or clinical development projects, including regulatory interactions.

Knowledge and Skills:

• Drug Development
• Scientific advocacy with policymakers/regulators

Behavioral Attributes:

• Decision-making and influencing skills
• Good interpersonal skills