Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Prato; Remoto; EUR 80.000 - 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 innovative clinical studies and engaging with global regulators to ensure drug approvals. The ideal candidate will have extensive experience in pulmonary medicine and a strong background in drug development. You will mentor teams, review critical study documents, and contribute to business development strategies. Join a dynamic environment where your expertise will drive advancements in respiratory health and make a significant impact on patient outcomes.

Competenze

• Minimum 18 years of experience as a practicing pulmonary clinical professional.
• Over 5 years in the pharmaceutical industry or clinical projects.

Mansioni

• Lead and manage Clinical Sciences respiratory projects ensuring timely delivery.
• Review and contribute to key study documents and CRO medical monitoring capabilities.

Conoscenze

Drug Development

Scientific advocacy with policymakers/regulators

Strong decision-making skills

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), Prato

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EU work permit required:

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Job Reference:

194136563343425536337140

Job Views:

2

Posted:

08.05.2025

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Job Description:

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

Role Overview:

This position is intended to 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 approvals, 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.
• Review and contribute to 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 protocol-related questions to CRO MM, site investigators, and study teams.
• Review blinded efficacy and safety data, listings, tables, deviations, and support review of SAE or SUSAR documents, addressing any data impacting subject safety or study integrity.
• Attend internal or joint CRO-sponsor safety meetings and review meeting minutes.
• Review blinded medical coding for AEs, SAEs, medications, and medical history, and interpret efficacy and safety data post-unblinding.
• Support business development for respiratory programs, including portfolio and lifecycle management, and contribute to medical affairs in BD and ROW development.
• Collaborate closely with internal stakeholders across various departments and participate in ad boards, forums, and meetings related to respiratory development.
• 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 of experience as a practicing pulmonary clinical professional, with over 5 years in the pharmaceutical industry or clinical projects involving clinical development and regulatory interactions.

Knowledge and Skills (Technical):

• Drug Development
• Scientific advocacy with policymakers/regulators

Behavioral Attributes:

• Strong decision-making and influencing skills, with good interpersonal skills.