Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Cagliari; Remoto; EUR 80.000 - 120.000; Tempo pieno

Descrizione del lavoro

An innovative firm is seeking a Clinical Development Lead to spearhead the advancement of new respiratory drugs. This role focuses on planning clinical studies, engaging with global regulators, and ensuring compliance with industry standards. The ideal candidate will possess extensive experience in pulmonary medicine and a strong background in drug development. Join a team that values collaboration and strategic thinking, where your expertise will drive impactful outcomes in the field of respiratory health. This position offers the flexibility to work from anywhere in Europe or the US, making it a unique opportunity for seasoned professionals.

Competenze

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

Mansioni

• Lead and manage Clinical Sciences respiratory projects.
• Contribute to and review key study documents and provide guidance on subject eligibility.
• Collaborate with internal stakeholders and engage with regulators.

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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Job Reference:

194136563343425536337142

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 aligning with the company's business objectives. It involves discussions with global regulators on respiratory clinical development pathways for facilitating drug approvals; review and due diligence of in-licensing respiratory molecules; and presentations in ad boards and global respiratory meetings.

Job Responsibilities:

• Lead, manage, and mentor Clinical Sciences respiratory projects, ensuring timely delivery of all deliverables. Responsibilities may include but are not limited to:
• Contributing to and reviewing key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
• Reviewing CRO medical monitoring capabilities during study start-up and RFP processes, including CVs, MMP, and investigator/site lists for vendor selection.
• Providing guidance on subject eligibility, deviations, and other medical, safety, or protocol-related questions to CRO MM, site investigators, and study teams.
• Reviewing blinded efficacy and safety data, listings, tables, deviations, and supporting review of blinded SAE or SUSAR documents, addressing or escalating any data impacting subject safety or study integrity.
• Attending internal or joint CRO-sponsor safety meetings and reviewing minutes.
• Reviewing blinded medical coding for AEs, SAEs, medications, and medical history, participating in BDRM, and interpreting efficacy and safety data after unblinding.
• Supporting business development for respiratory programs, portfolio, and medical affairs, including new and lifecycle management programs.
• Collaborating with internal stakeholders across research, regulatory, clinical operations, medical affairs, legal, and others. Participating in ad boards, forums, and meetings. Engaging with regulators on clinical development pathways and approval processes.
• Developing projects and evaluating new business opportunities or internal drug candidates to expand 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.

Knowledge and Skills (Functional / Technical):

• Drug Development
• Scientific advocacy with policymakers/regulators

Behavioral Attributes:

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