Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Belluno; Remoto; EUR 120.000 - 180.000; 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 new drugs, overseeing study planning, and ensuring compliance with regulations. The successful candidate will engage with global regulators, mentor project teams, and contribute to strategic discussions on drug approval pathways. If you have extensive experience in pulmonary clinical practice and a passion for advancing drug development, this opportunity offers a chance to make a significant impact in the healthcare sector.

Competenze

• 18+ years in pulmonary clinical practice with 5+ years in pharmaceutical development.
• Strong decision-making and influencing skills.

Mansioni

• Lead and mentor Clinical Sciences respiratory projects ensuring timely delivery.
• Review key study documents and provide guidance on medical issues.

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 (Pulmonology), Belluno

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Job Category: Other

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EU work permit required:

Yes

Job Reference:

194136563343425536337151

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 with the company's business objectives. It involves 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.
• 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 lists.
• Provide guidance on subject eligibility, deviations, and other medical or protocol-related issues 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, addressing any data impacting safety or study integrity.
• Attend internal or joint CRO-sponsor medical monitoring safety meetings and review minutes.
• Review blinded medical coding for AEs, SAEs, medications, and medical history; participate in BDRM and interpret efficacy and safety data post-unblinding.
• Support business development for respiratory programs and portfolio, including medical affairs and lifecycle management programs.
• Collaborate with internal stakeholders across departments and participate in ad boards, forums, and regulatory discussions.
• Develop projects and evaluate new business opportunities or internal drug candidates to expand the respiratory, allergy, and inflammation pipeline, driving strategy from clinical 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 (Functional / Technical):

• Drug Development
• Scientific advocacy with policymakers/regulators

Behavioral Attributes:

• Strong decision-making and influencing skills; good interpersonal skills.