Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Lecco; In loco; EUR 90.000 - 150.000; Tempo pieno

Descrizione del lavoro

A forward-thinking company is seeking a Director/Sr Director for Clinical Development in Pulmonology. This critical role involves leading clinical projects, managing drug development processes, and collaborating with global regulators to ensure compliance and facilitate drug approvals. The ideal candidate will possess extensive experience in pulmonary medicine, strong decision-making skills, and the ability to influence stakeholders. Join this innovative firm to make a significant impact on the development of new therapies in respiratory health, while working in a dynamic and supportive environment that values your expertise and contributions.

Competenze

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

Mansioni

• Lead and mentor Clinical Sciences respiratory projects.
• Review key study documents and CRO medical monitoring capabilities.
• Support business development for respiratory programs.

Conoscenze

Drug Development

Scientific advocacy with policymakers/regulators

Decision-making skills

Interpersonal skills

Formazione

MD / MS

MD Internal and Pulmonary/Critical Care Medicine

Descrizione del lavoro

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

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Job Reference:

194136563343425536337154

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 align them with company's business objectives. It involves discussions with global regulators on respiratory clinical development pathways to facilitate drug approvals, review & due diligence of in-licensing respiratory molecules, and participation in ad boards and global respiratory meetings.

Job Responsibilities:

1. Lead, manage, and mentor Clinical Sciences respiratory projects ensuring timely delivery of all deliverables.
2. Contribute to and review key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
3. Review CRO medical monitoring capabilities during study start-up and RFP processes, including CVs, MMP, and investigator/site lists.
4. Provide guidance on subject eligibility, deviations, and other medical, safety, or protocol-related questions.
5. Review blinded efficacy and safety data, listings, tables, deviations, and provide supportive review of blinded SAE or SUSAR documents, addressing any data impacting subject safety or study integrity.
6. Participate in internal or joint CRO-sponsor safety meetings and review minutes.
7. Review blinded medical coding for AEs, SAEs, medications, and medical history, and interpret efficacy and safety data post-unblinding.
8. Support business development for respiratory programs and portfolio, including new and lifecycle management programs.
9. Collaborate with internal stakeholders across departments and participate in ad boards, forums, and meetings.
10. Contribute to development projects and evaluate new business opportunities to expand the respiratory, allergy, and inflammation pipeline.

Knowledge and Education:

Educational Qualifications:

• MD / MS
• MD 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 drug 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.