Director/ Sr Director - Clinical Development (Pulmonology)

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

Descrizione del lavoro

An established industry player is seeking a seasoned professional to lead clinical development in respiratory drug projects. This role involves strategic oversight of clinical studies, regulatory discussions, and collaboration with various stakeholders to ensure compliance and successful drug approvals. With a focus on innovative approaches, you'll drive the development pipeline while mentoring a team of clinical scientists. If you have extensive experience in pulmonary medicine and a passion for advancing drug development, this is an exciting opportunity to make a significant impact in the field.

Competenze

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

Mansioni

• Lead and mentor Clinical Sciences respiratory projects for timely delivery.
• Review key study-related documents and CRO medical monitoring capabilities.
• Collaborate with internal stakeholders and participate in regulatory discussions.

Conoscenze

Drug Development

Scientific advocacy with policymakers/regulators

Strong decision-making skills

Good interpersonal skills

Formazione

MD / MS

MD in Internal and Pulmonary/Critical Care Medicine

Descrizione del lavoro

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 aligned with the company's business objectives. The role involves discussions with global regulators on respiratory clinical development pathways to facilitate drug approvals, review and 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 to ensure 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, MMP, and investigator/site lists for vendor selection.
4. Provide guidance on subject eligibility, deviations, and other medical or safety-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 data impacting subject safety or study integrity.
6. Attend 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 after unblinding.
8. Support business development for respiratory programs and portfolio, including medical affairs in BD and ROW development.
9. Collaborate with internal stakeholders across departments and participate in ad boards, forums, and meetings to 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 involving 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.