Director/ Sr Director - Clinical Development (Respiratory)

Buscojobs; Abruzzo; Remoto; EUR 90.000 - 150.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a highly experienced professional to lead clinical development for innovative respiratory drugs. This role encompasses managing clinical projects, engaging with global regulators, and ensuring compliance with regulations while aligning with business objectives. The successful candidate will leverage their extensive experience in drug development and regulatory interactions to drive strategy from candidate evaluation to registration. Join a dynamic environment where your expertise will shape the future of respiratory health and contribute to groundbreaking advancements in medicine.

Competenze

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

Mansioni

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

Conoscenze

Drug Development

Regulatory Interactions

Clinical Project Management

Scientific Advocacy

Decision-Making

Interpersonal Skills

Formazione

MD/MS in Internal Medicine

MD/MS in 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, including conception of innovative approaches to plan clinical studies and support end-to-end drug development in accordance with all applicable regulations and aligning them with the company's business objectives. The role involves discussions with global regulators on respiratory clinical development pathways to facilitate drug approvals, review & due diligence of in-licensing respiratory molecules, and presentations 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 and amendments, eCRFs, SAP, MMP, SMP, and TLFs.
3. Review CRO medical monitoring capabilities during study start-up and RFP process, including CVs, MMP, and investigator/site lists for vendor selection or final CRO determination.
4. Provide guidance on subject eligibility, deviations, and other medical, safety, or protocol-related questions to CRO MM, site investigators, and study team.
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 prior to DBL and interpret efficacy and safety post-unblinding.
8. Support business development for respiratory programs, portfolio, medical affairs, and lifecycle management programs.
9. Build and maintain collaboration with internal stakeholders across various departments.
10. Participate in ad boards, respiratory forums, and meetings; engage with regulators on development pathways and approvals.
11. Develop projects and evaluate new business opportunities or internal drug candidates to expand the respiratory, allergy, and inflammation pipeline.
12. 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 interactions.

Behavioral Attributes :

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