Director/ Sr Director - Clinical Development (Respiratory)

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

Descrizione del lavoro

An established industry player is seeking a highly experienced professional to lead the clinical development of innovative respiratory drugs. This pivotal role involves managing projects, mentoring teams, and collaborating with global regulators to ensure compliance and expedite drug approvals. With a focus on strategic development, you will drive the delivery of respiratory programs from candidate evaluation to registration. If you possess a strong background in drug development and regulatory affairs, this is an exceptional opportunity to make a significant impact in the pharmaceutical industry.

Competenze

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

Mansioni

• Lead and manage Clinical Sciences respiratory projects.
• Review key study-related documents and provide guidance.
• Engage in discussions with regulators for faster approvals.

Conoscenze

Drug Development

Regulatory Interactions

Clinical Project Management

Interpersonal Skills

Decision-Making

Formazione

MD / MS in Internal Medicine

MD / MS in Pulmonary Medicine

MD / MS in 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, focusing on innovative approaches to plan clinical studies and support end-to-end drug development in accordance with all applicable regulations and aligning 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 milestones.
2. 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.
4. Provide guidance on subject eligibility, deviations, and other medical, safety, or protocol-related questions to CRO medical monitors, 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 any data impacting subject safety or study integrity.
6. Attend internal or joint CRO-sponsor safety meetings and review meeting minutes.
7. Review blinded medical coding for AEs, SAEs, medications, and medical history, and participate in BDRM prior to database lock, providing primary interpretation of efficacy and safety after 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 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 to facilitate faster approvals.
11. Develop projects and evaluate new business opportunities or internal target drug candidates for pipeline expansion and business growth.
12. Drive the overall 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 interactions.

Behavioral Attributes:

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