Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Caserta; Remoto; EUR 90.000 - 150.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a dynamic Director/Sr Director for Clinical Development in Pulmonology. This pivotal role involves leading clinical projects, mentoring teams, and ensuring compliance with regulatory standards. You will engage with global regulators, contribute to innovative drug development strategies, and collaborate with various stakeholders to drive the respiratory program's success. If you have extensive experience in pulmonary medicine and a passion for advancing drug development, this position offers a unique opportunity to make a significant impact in the field.

Competenze

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

Mansioni

• Lead and manage Clinical Sciences respiratory projects.
• Contribute to and review key study documents.
• Support business development for respiratory programs.

Conoscenze

Drug Development

Scientific advocacy with policymakers/regulators

Decision-making skills

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), Caserta

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EU work permit required:

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Job Reference:

194136563343425536337147

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, including conception of innovative approaches to plan clinical studies and support end-to-end drug development in accordance with all applicable regulations and aligning them with the company's business objectives. Responsibilities include discussions with global regulators on respiratory clinical development pathways for drug approval, 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 milestones.
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 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 safety or integrity.
6. Attend internal or joint 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. Develop projects and evaluate new business opportunities, driving respiratory program strategy 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 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.