Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Parma; Remoto; EUR 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

A forward-thinking company is seeking a Director/Sr Director of Clinical Development specializing in Pulmonology. This pivotal role will lead the clinical development of innovative drugs, ensuring compliance with regulations and alignment with business objectives. The ideal candidate will have extensive experience in pulmonary clinical practice and a strong background in drug development, regulatory interactions, and team leadership. Join a dynamic team that collaborates with global regulators and drives strategies for faster drug approvals, making a significant impact in the respiratory field.

Competenze

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

Mansioni

• Lead and manage clinical sciences respiratory projects.
• Collaborate with internal stakeholders and engage with regulators.
• Review and contribute to key study documents.

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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Director/ Sr Director - Clinical Development (Pulmonology), Parma

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Job Reference:

194136563343425536337114

Job Views:

2

Posted:

08.05.2025

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Job Description:

Pls 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 aligned with the company's business objectives. Responsibilities include discussions with global regulators on respiratory clinical development pathways for facilitating drug approvals; review & due diligence of in-licensing respiratory molecules; presentation in ad boards and global respiratory meetings.

Job Responsibilities:

• Lead, manage, and mentor Clinical Sciences respiratory projects to ensure timely delivery of all milestones and deliverables.
• Review and contribute to key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
• Assess CRO medical monitoring capabilities during study start-up and RFP processes, including review of CVs, MMP, and investigator/site lists for vendor selection.
• Provide guidance on subject eligibility, deviations, and other medical, safety, or protocol-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, addressing any data impacting subject safety or study integrity.
• Attend internal or joint CRO-sponsor safety meetings and review medical meeting minutes.
• 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.
• Support business development for respiratory programs, portfolio, and medical affairs in BD and ROW development, including lifecycle management programs.
• Collaborate closely with internal stakeholders such as Preclinical Research, Toxicology, DMPK, Regulatory, ClinOps, Project Management, Medical Affairs, and legal. Participate in ad boards, forums, and presentations. Engage with regulators on clinical development pathways to facilitate faster approvals.
• Develop projects and evaluate new business opportunities or internal drug candidates to expand the respiratory, allergy, and inflammation pipeline, driving strategy and delivery 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 of experience as a practicing pulmonary clinical professional, with over 5 years in the pharmaceutical industry or clinical projects in clinical development, including 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.