Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Frosinone; 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 in Pulmonology. This pivotal role involves leading innovative drug development projects and engaging with global regulators to facilitate drug approvals. The ideal candidate will have extensive experience in pulmonary clinical practice and a strong background in the pharmaceutical industry. You will be responsible for mentoring teams, reviewing critical study documents, and driving strategy for new business opportunities. Join a forward-thinking company dedicated to advancing healthcare solutions and making a significant impact in the field of respiratory medicine.

Competenze

• Minimum 18 years in pulmonary clinical practice with over 5 years in the pharmaceutical industry.
• Experience with regulatory interactions for drug development.

Mansioni

• Lead and mentor Clinical Sciences respiratory projects, ensuring timely delivery.
• Review key study documents and provide guidance on subject eligibility.

Conoscenze

Drug Development

Scientific advocacy with policymakers/regulators

Strong 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), Frosinone

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Job Reference:

194136563343425536337162

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 designed to lead and support the clinical development of new drugs, focusing on innovative approaches to plan clinical studies and support end-to-end drug development in compliance 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 advisory boards and global respiratory meetings.

Job Responsibilities:

1. Lead, manage, and mentor Clinical Sciences respiratory projects, ensuring timely delivery of all objectives.
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 for vendor selection.
4. Provide guidance on subject eligibility, deviations, and other medical, safety, or protocol-related 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 integrity.
6. Attend internal or joint CRO-sponsor medical monitoring safety meetings and review minutes.
7. Review blinded medical coding for adverse events, medications, and medical history, and participate in BDRM prior to database lock, providing primary interpretation post-unblinding.
8. Support business development for respiratory programs and portfolio, including medical affairs, BD, and ROW development, focusing on new and lifecycle management programs.
9. Maintain collaboration with internal stakeholders across departments and participate in ad boards, forums, and presentations. Engage with regulators on development pathways and approval processes.
10. Develop projects and evaluate new business opportunities or internal drug 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 in pulmonary clinical practice with over 5 years in the pharmaceutical industry or clinical projects, including regulatory interactions for 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.