Director/ Sr Director - Clinical Development (Respiratory)

Buscojobs; Emilia-Romagna; Remoto; EUR 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

A leading company is seeking a Clinical Development Head to oversee innovative drug development in respiratory medicine. This role involves managing projects, engaging with regulators, and ensuring compliance with regulations. Ideal candidates will have extensive experience in pulmonary medicine and drug development, with strong decision-making and interpersonal skills.

Competenze

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

Mansioni

• Lead and manage Clinical Sciences respiratory projects.
• Review and contribute to key study documents.
• Engage in discussions with regulators on clinical development pathways.

Conoscenze

Decision-Making

Interpersonal Skills

Scientific Advocacy

Formazione

MD/MS in Internal and Pulmonary/Critical Care Medicine

Descrizione del lavoro

Note: The 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 and due diligence of in-licensing respiratory molecules, and participation in advisory boards and global respiratory meetings.

Job Responsibilities:

1. Lead, manage, and mentor Clinical Sciences respiratory projects to ensure timely delivery of all milestones.
2. Review and contribute to key study 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, addressing or escalating data impacting subject safety or study integrity.
6. Attend safety meetings, review medical meeting minutes, and participate in blinded medical coding and primary interpretation of efficacy and safety data after unblinding.
7. Support business development for respiratory programs, including new and lifecycle management programs, and collaborate with internal stakeholders across multiple departments.
8. Participate in ad boards, respiratory forums, and presentations at respiratory meetings.
9. Engage in discussions with regulators on clinical development pathways and faster approvals.
10. Evaluate new business opportunities or internal target drug candidates to expand the respiratory, allergy, and inflammation pipeline.
11. Drive the overall strategy and delivery of respiratory programs from candidate evaluation to registration.

Knowledge and Education: 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 development, including regulatory interactions.

Knowledge and Skills: Expertise in drug development, scientific advocacy with policymakers/regulators.

Behavioral Attributes: Strong decision-making and influencing skills, good interpersonal skills.

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