Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Rimini; In loco; EUR 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

An established industry player seeks a Director/Sr Director for Clinical Development in Pulmonology. This pivotal role involves leading innovative drug development projects, engaging with global regulators, and ensuring compliance with all regulations. The successful candidate will mentor teams, contribute to critical study documents, and drive strategic initiatives in respiratory health. If you have a strong background in pulmonary medicine and a passion for advancing clinical research, this opportunity offers a chance to make a significant impact in the field.

Competenze

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

Mansioni

• Lead and manage Clinical Sciences respiratory projects.
• Review key study documents and provide guidance on protocols.
• Collaborate with internal stakeholders and engage with regulators.

Conoscenze

Drug Development

Scientific advocacy

Decision-making

Interpersonal skills

Formazione

MD / MS

MD with Internal and Pulmonary/Critical Care Medicine specialization

Descrizione del lavoro

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

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EU work permit required:

Yes

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Job Reference:

194136563343425536337130

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, conceive 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 drug approval facilitation, 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.
• 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 for vendor selection.
• 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 blinded SAE or SUSAR documents, addressing any data impacting safety or study integrity.
• Participate in 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 and portfolio, including medical affairs in BD and ROW development, new initiatives, and lifecycle management programs.
• Collaborate with internal stakeholders across departments, participate in ad boards, forums, and presentations, and engage with regulators on development pathways and approval processes.
• Develop projects and evaluate new business opportunities or internal drug candidates to expand the respiratory, allergy, and inflammation pipeline, driving strategy from candidate evaluation to registration.

Knowledge and Education:

Educational Qualifications:

• MD / MS
• MD with Internal and Pulmonary/Critical Care Medicine specialization

Experience:

• Minimum 18 years of experience as a practicing pulmonary clinical professional, with over 5 years in pharmaceutical industry or clinical projects, including regulatory interactions for drug development.

Knowledge and Skills (Functional / Technical):

• Drug Development
• Scientific advocacy with policymakers/regulators

Behavioral Attributes:

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