Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Napoli; In loco; EUR 80.000 - 150.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a Director/Senior Director for Clinical Development in Pulmonology. This pivotal role involves leading the clinical development of innovative drugs, managing cross-functional teams, and engaging with global regulators to ensure compliance and expedite approvals. The ideal candidate will have extensive experience in pulmonary clinical practice and a strong background in pharmaceutical development. This is an exceptional opportunity to shape the future of respiratory medicine while working in a dynamic and collaborative environment.

Competenze

• Minimum 18 years in pulmonary clinical practice with over 5 years in pharmaceutical development.
• Experience in regulatory interactions and clinical development.

Mansioni

• Lead and mentor Clinical Sciences respiratory projects, ensuring timely delivery.
• Engage with regulators on clinical development pathways for faster approvals.

Conoscenze

Drug Development

Scientific advocacy with policymakers/regulators

Strong decision-making and influencing skills

Good interpersonal skills

Formazione

MD / MS

MD in Internal and Pulmonary/Critical Care Medicine

Descrizione del lavoro

The provided job description is comprehensive but could benefit from improved formatting for clarity and readability. The content is relevant and covers key responsibilities, qualifications, and skills. I will enhance the formatting by properly structuring the sections using HTML tags and removing any redundant or irrelevant symbols, ensuring the description remains focused and professional.

Here is the refined version:

Job Title: Director/ Senior Director - Clinical Development (Pulmonology), Napoli

Client:

Location:

Job Category:

Other

EU work permit required:

Yes

Job Reference:

19413656334342553633719

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, focusing on innovative approaches to plan clinical studies and support end-to-end drug development in accordance with all applicable regulations and aligning with the company's business objectives. Responsibilities include discussions with global regulators on respiratory clinical development pathways for drug approval, 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 deliverables.
• 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 startup and RFP processes, including CVs, MMP, and investigator/site lists.
• Provide guidance on subject eligibility, deviations, and other medical or safety-related questions to CRO MM, site investigators, and study teams.
• Review blinded efficacy and safety data, listings, tables, deviations, and support review of blinded SAE or SUSAR documents, escalating issues impacting safety or integrity.
• Attend internal and joint CRO-sponsor medical monitoring safety meetings and review minutes.
• Review blinded medical coding for AEs, SAEs, medications, and medical history, and interpret efficacy and safety data after unblinding.
• Support business development for respiratory programs and portfolio, including new and lifecycle management programs.
• Collaborate with internal stakeholders across departments and participate in ad boards, forums, and presentations.
• Engage with regulators on clinical development pathways and facilitate faster approvals.
• Develop projects and evaluate new business opportunities or internal drug candidates to expand respiratory, allergy, and inflammation pipelines, leading strategy and delivery from 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/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