Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Bergamo; Remoto; EUR 80.000 - 150.000; Tempo pieno

Descrizione del lavoro

An innovative firm is seeking a Clinical Development Lead to spearhead the advancement of new respiratory drugs. This pivotal role involves managing clinical projects, engaging with global regulators, and ensuring compliance with all regulations. You will contribute to the strategic planning of clinical studies and support drug development from inception to approval. The ideal candidate will have extensive experience in the pharmaceutical industry, particularly in pulmonary medicine, and possess strong decision-making and interpersonal skills. Join this forward-thinking company and make a significant impact in the healthcare sector.

Competenze

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

Mansioni

• Lead and mentor Clinical Sciences respiratory projects.
• Review key study-related documents and provide guidance.
• Collaborate with internal stakeholders and engage with regulators.

Conoscenze

Drug Development

Scientific advocacy with policymakers/regulators

Good decision-making and influencing skills

Strong interpersonal skills

Formazione

MD / MS

MD in Internal and Pulmonary/Critical Care Medicine

Descrizione del lavoro

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Job Reference:

194136563343425536337110

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, focusing on innovative approaches to planning clinical studies and supporting 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 to facilitate drug approvals, review and due diligence of in-licensing respiratory molecules, and presentations at 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-related 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, MMPs, and investigator/site lists for vendor selection.
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 or escalating data impacting 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, participate in BDRM prior to DBL, and interpret efficacy and safety post-unblinding.
8. Support business development for respiratory programs and portfolio, including medical affairs in BD and ROW development, new and lifecycle management programs.
9. Collaborate closely with internal stakeholders and participate in ad boards, respiratory forums, and meetings, engaging with regulators on clinical development pathways for faster approvals.
10. Develop projects and evaluate new business opportunities or internal drug candidates to expand the respiratory, allergy, and inflammation pipeline, driving strategy and delivery 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 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:

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