Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Bari; Remoto; EUR 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

An established industry player seeks a dynamic Director/Sr Director to lead clinical development in Pulmonology. This pivotal role involves overseeing drug development, engaging with global regulators, and ensuring compliance with regulations. The ideal candidate will have extensive experience in clinical practice and the pharmaceutical industry, coupled with strong decision-making and interpersonal skills. Join a forward-thinking organization committed to advancing respiratory health and making a significant impact in the field.

Competenze

• Minimum 18 years of experience in pulmonary clinical practice.
• Over 5 years in pharmaceutical industry or clinical projects.

Mansioni

• Lead and mentor Clinical Sciences respiratory projects.
• Review key study documents and assess CRO medical monitoring capabilities.
• Support business development for respiratory programs.

Conoscenze

Drug Development

Scientific advocacy with policymakers/regulators

Strong decision-making skills

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), bari

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EU work permit required:

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Job Reference:

194136563343425536337117

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, including planning clinical studies and supporting end-to-end drug development in accordance with all applicable regulations and aligning 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 advisory boards and global respiratory meetings.

Job Responsibilities:

1. Lead, manage, and mentor Clinical Sciences respiratory projects, ensuring timely delivery of all milestones.
2. Review key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
3. Assess CRO medical monitoring capabilities during study start-up and vendor selection processes.
4. Provide guidance on subject eligibility, deviations, and protocol-related questions to CRO and site staff.
5. Review blinded efficacy and safety data, and support safety monitoring and data integrity.
6. Participate in medical monitoring safety meetings and review related minutes.
7. Review medical coding for adverse events and participate in BDRM and efficacy/safety interpretation.
8. Support business development for respiratory programs and portfolio management.
9. Collaborate with internal stakeholders and participate in industry forums and regulator discussions.
10. Develop projects and evaluate new business opportunities to expand the respiratory pipeline 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:

• Drug Development
• Scientific advocacy with policymakers/regulators

Behavioral Attributes:

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