Director/ Sr Director - Clinical Development (Respiratory)

JR Italy; Monza; Remoto; EUR 80.000 - 150.000; Tempo pieno

Descrizione del lavoro

An innovative firm is seeking a seasoned clinical professional to lead the development of new respiratory drugs. This role involves guiding clinical studies, engaging with global regulators, and ensuring compliance with regulations. The ideal candidate will have extensive experience in pulmonary medicine and drug development, with a proven track record of managing clinical projects. Join a dynamic team focused on advancing healthcare solutions and making a significant impact in the field of respiratory medicine. If you are passionate about driving drug development and have the expertise to influence regulatory pathways, this opportunity is perfect for you.

Competenze

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

Mansioni

• Lead and manage Clinical Sciences respiratory projects.
• Review key study documents and CRO medical monitoring capabilities.
• Collaborate with stakeholders for clinical development pathways.

Conoscenze

Drug Development

Scientific Advocacy

Decision-Making

Interpersonal Skills

Formazione

MD / MS

MD in Internal and Pulmonary/Critical Care Medicine

Descrizione del lavoro

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Job Reference:

745023147201685094433711

Job Views:

1

Posted:

06.05.2025

Expiry Date:

20.06.2025

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Job Description:

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

Role Overview:

This position is intended to 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 accordance with all applicable regulations and aligned with the company's business objectives. The role involves discussions with global regulators on respiratory clinical development pathways for drug approvals, review and due diligence of in-licensing respiratory molecules, and participation in 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 for vendor selection.
4. Provide guidance on subject eligibility, deviations, and other medical 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 subject safety or study integrity.
6. Attend internal or joint CRO-sponsor safety meetings and review minutes.
7. Review blinded medical coding for AEs, SAEs, medications, and medical history, participate in BDRM prior to DBL, and interpret efficacy and safety data post-unblinding.
8. Support business development for respiratory programs, portfolio, and medical affairs, including new and lifecycle management programs.
9. Collaborate with internal stakeholders across departments and participate in ad boards, forums, and meetings with regulators to facilitate clinical development pathways and approvals.
10. Develop projects and evaluate new business opportunities or internal drug candidates for respiratory, allergy, and inflammation pipelines, driving strategy from 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 development projects, including regulatory interactions for drug development.

Knowledge and Skills (Functional / Technical):

• Drug Development
• Scientific advocacy with policymakers/regulators

Behavioral Attributes:

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