Director/ Sr Director - Clinical Development (Respiratory)

JR Italy; Varese; Remoto; EUR 100.000 - 200.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a Director/Sr Director for Clinical Development in Respiratory. This pivotal role focuses on leading innovative clinical studies and supporting drug development while ensuring compliance with regulations. The ideal candidate will have extensive experience in pulmonary clinical practice and a strong background in the pharmaceutical industry. You'll engage with global regulators, manage clinical projects, and collaborate with internal stakeholders to drive the success of respiratory programs. Join a dynamic team dedicated to advancing healthcare and making a significant impact in the field.

Competenze

• 18+ years in pulmonary clinical practice with 5+ years in pharmaceutical industry.
• Experience with regulatory interactions and clinical development projects.

Mansioni

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

Conoscenze

Drug Development

Scientific advocacy with policymakers/regulators

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 (Respiratory), Varese

Job Details:

• Client: [Client Name]
• Location: [Location]
• Job Category: Other
• EU work permit required: Yes

Job Reference: 745023147201685094433712

Job Views: 2

Posted: 06.05.2025

Expiry Date: 20.06.2025

Job Description:

Note: Incumbent can be based anywhere in Europe or the US.

Role Overview:

This position leads and supports 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. Responsibilities include discussions with global regulators on respiratory clinical development pathways, review & due diligence of in-licensing respiratory molecules, and participation in ad boards and global respiratory meetings.

Job Responsibilities:

• Lead, manage, and mentor Clinical Sciences respiratory projects, ensuring timely delivery of all milestones.
• Contribute to and review key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
• Review CRO medical monitoring capabilities during study start-up and vendor selection processes.
• Provide guidance on subject eligibility, deviations, and protocol-related questions to CRO MM, site investigators, and study teams.
• Review blinded efficacy and safety data, and support review of SAE or SUSAR documents, addressing any data impacting subject safety or study integrity.
• Participate in medical monitoring safety meetings and review minutes.
• Review medical coding for adverse events and participate in BDRM prior to database lock, providing primary interpretation post-unblinding.
• Support business development for respiratory programs and portfolio management.
• Collaborate with internal stakeholders across departments and participate in respiratory forums and meetings.
• Drive strategy and delivery of respiratory programs 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 pharmaceutical industry or clinical development projects, including regulatory interactions.

Knowledge and Skills:

• Drug Development
• Scientific advocacy with policymakers/regulators

Behavioral Attributes:

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