Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Ascoli Piceno; In loco; EUR 90.000 - 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 the clinical development of innovative respiratory drugs, ensuring compliance with regulations, and aligning with business objectives. The successful candidate will manage various projects, mentor teams, and collaborate with global regulators. If you have extensive experience in pulmonary clinical practice and a passion for drug development, this is an exciting opportunity to make a significant impact in the field.

Competenze

• Minimum 18 years in pulmonary clinical practice.
• Over 5 years in pharmaceutical clinical development.

Mansioni

• Lead and mentor Clinical Sciences respiratory projects.
• Review key study documents and assess CRO capabilities.
• Drive strategy and delivery of respiratory programs.

Conoscenze

Drug Development

Scientific advocacy with policymakers/regulators

Strong decision-making 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), Ascoli Piceno

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EU work permit required:

Yes

Job Reference:

194136563343425536337161

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, including planning clinical studies and supporting end-to-end drug development in accordance with all applicable regulations and aligning them with the company's business objectives. Responsibilities include discussions with global regulators on respiratory clinical development pathways, 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 to ensure timely delivery of all milestones.
2. Review and contribute to key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
3. Assess CRO medical monitoring capabilities during study startup and vendor selection processes.
4. Guide on subject eligibility, deviations, and other medical or safety-related questions.
5. Review blinded efficacy and safety data, listings, tables, deviations, and address issues impacting safety or study integrity.
6. Participate in medical monitoring safety meetings and review meeting minutes.
7. Review blinded medical coding and participate in BDRM prior to database lock, providing primary interpretation post-unblinding.
8. Support business development activities for respiratory programs and portfolio management.
9. Collaborate with internal stakeholders across various departments and participate in industry forums and meetings.
10. Drive strategy and delivery of respiratory programs from candidate evaluation to registration.

Knowledge and Education:

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 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.