Director/ Sr Director - Clinical Development (Respiratory)

Buscojobs; Umbria; Remoto; EUR 80.000 - 150.000; Tempo pieno

Descrizione del lavoro

An innovative firm is seeking a seasoned professional to spearhead clinical development for respiratory drugs. This pivotal role involves guiding projects from conception to registration while ensuring compliance with regulations. The ideal candidate will possess extensive experience in drug development and regulatory interactions, with a strong focus on collaboration across various departments. This position offers a unique opportunity to influence the future of respiratory medicine and drive strategic initiatives within a dynamic environment. If you're passionate about making an impact in the pharmaceutical industry, this role is perfect for you.

Competenze

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

Mansioni

• Lead and mentor Clinical Sciences respiratory projects.
• Review key study documents and provide guidance on protocols.
• Engage in discussions with regulators for faster approvals.

Conoscenze

Drug Development

Regulatory Interactions

Clinical Project Development

Interpersonal Skills

Decision-Making

Formazione

MD/MS in Internal Medicine

Specialization in Pulmonary/Critical Care Medicine

Descrizione del lavoro

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, involving 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 includes 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, ensuring timely delivery of all deliverables.
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 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 provide supportive review of blinded SAE or SUSAR documents, addressing or escalating data impacting subject 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, and interpret efficacy and safety data post-unblinding.
8. Support business development for respiratory programs, medical affairs, and lifecycle management, including new programs and pipeline expansion.
9. Collaborate with internal stakeholders across various departments and participate in ad boards, respiratory forums, and meetings.
10. Engage in discussions with regulators on clinical development pathways for faster approvals.
11. Develop projects and evaluate new business opportunities or internal drug candidates for pipeline growth.
12. Drive the strategy and delivery of respiratory programs from candidate evaluation to registration.

Knowledge and Education:

Educational Qualifications: MD/MS, with specialization 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, and regulatory interactions.

Behavioral Attributes:

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