Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Firenze; In loco; EUR 80.000 - 150.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a highly experienced Clinical Development Leader to spearhead innovative drug development projects. This pivotal role involves managing clinical studies, collaborating with global regulators, and mentoring project teams to ensure compliance with regulations. The ideal candidate will possess extensive experience in pulmonary medicine and drug development, showcasing strong decision-making and interpersonal skills. Join a forward-thinking organization dedicated to advancing healthcare solutions and making a significant impact in the field of respiratory health.

Competenze

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

Mansioni

• Lead and manage Clinical Sciences respiratory projects, ensuring timely delivery.
• Review key study documents and provide guidance on subject eligibility.
• Collaborate with internal stakeholders and regulators on clinical development.

Conoscenze

Drug Development

Scientific advocacy

Decision-making skills

Interpersonal skills

Formazione

MD / MS

MD in Internal and Pulmonary/Critical Care Medicine

Descrizione del lavoro

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Client:

Location:

Job Category:

Other

EU work permit required:

Yes

Job Reference:

19413656334342553633714

Job Views:

2

Posted:

08.05.2025

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 approval facilitation, 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 process, including CVs, MMP, and investigator/site lists.
4. Provide guidance on subject eligibility, deviations, and other medical, safety, or protocol-related questions to CRO MM, site investigators, and study teams.
5. 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.
6. Attend internal or joint CRO-sponsor medical monitoring safety meetings and review minutes.
7. Review blinded medical coding for AEs, SAEs, medications, and medical history, and interpret efficacy and safety data after unblinding.
8. Support business development for respiratory programs, portfolio, med affairs, and lifecycle management programs.
9. Collaborate with internal stakeholders across departments, participate in ad boards, forums, and meetings, and discuss clinical development pathways with regulators.
10. 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 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 drug development, including regulatory interactions.

Knowledge and Skills:

• Drug Development
• Scientific advocacy with policymakers/regulators

Behavioral Attributes:

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