Director/ Sr Director - Clinical Development (Pulmonology)

Buscojobs; Emilia-Romagna; Remoto; EUR 120.000 - 160.000; Tempo pieno

Descrizione del lavoro

A leading company is seeking a Clinical Development Head to oversee innovative drug development in respiratory medicine. The role involves managing clinical projects, engaging with regulators, and driving strategies from candidate evaluation to registration. Ideal candidates will have extensive experience in pulmonary medicine and a strong background in the pharmaceutical industry.

Competenze

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

Mansioni

• Lead and manage Clinical Sciences respiratory projects.
• Review key study-related documents and provide guidance on medical questions.
• Support business development for respiratory programs.

Conoscenze

Decision-Making

Influencing Skills

Interpersonal Abilities

Formazione

MD / MS in Internal and Pulmonary / Critical Care Medicine

Descrizione del lavoro

Pls 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 aligned with the company's business objectives. Responsibilities include 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-related documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
3. Review CRO medical monitoring capabilities during study startup 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 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, escalating any data impacting subject safety or study integrity.
6. Attend internal or joint CRO-sponsor safety meetings and review medical meeting minutes.
7. Review blinded medical coding for AEs, SAEs, medications, and medical history, participate in BDRM, and interpret efficacy and safety data post-unblinding.
8. Support business development for respiratory programs, including new and lifecycle management programs, and collaborate with internal stakeholders.
9. Participate in ad boards, respiratory forums, and meetings, and engage in discussions with regulators on development pathways.
10. Evaluate new business opportunities or internal target drug candidates for pipeline expansion and business growth.
11. Drive the strategy and delivery of respiratory programs from candidate evaluation to registration.

Knowledge and Education :

Educational Qualifications : MD / MS 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 project management, including regulatory interactions.

Knowledge and Skills :

Expertise in drug development, scientific advocacy, and regulatory engagement.

Behavioral Attributes :

Strong decision-making and influencing skills, with good interpersonal abilities.