Director/ Sr Director - Clinical Development (Pulmonology)

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

Descrizione del lavoro

An established industry player is seeking a seasoned clinical professional to lead innovative drug development projects in respiratory medicine. This role offers the unique opportunity to influence clinical study designs and interact with global regulators to facilitate drug approvals. You will be at the forefront of developing strategies to expand the respiratory pipeline and ensure compliance with regulations. If you have extensive experience in pulmonary medicine and a passion for advancing healthcare, this position is perfect for you.

Competenze

• Minimum of 18 years of experience as a practicing pulmonary clinical professional.
• At least 5 years in the pharmaceutical industry or clinical project management.

Mansioni

• Lead and manage Clinical Sciences respiratory projects for timely delivery.
• Review key study documents and assess CRO medical monitoring capabilities.
• Foster collaboration with internal stakeholders and engage with regulators.

Conoscenze

Drug Development

Scientific advocacy

Decision-making

Interpersonal skills

Formazione

MD / MS

MD with specialization in Internal and Pulmonary/Critical Care Medicine

Descrizione del lavoro

Note: Incumbent can be based anywhere in Europe or the US.

Role Overview:

This position is responsible for leading and supporting the clinical development of new drugs, focusing on innovative approaches to plan clinical studies and support end-to-end drug development in compliance with all applicable regulations and aligned 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 advisory boards and global respiratory meetings.

Job Responsibilities:

1. Lead, manage, and mentor Clinical Sciences respiratory projects to ensure timely delivery of all milestones. Responsibilities include, but are not limited to:
2. Review and contribute to key study documents such as protocols, informed consent forms, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
3. Assess CRO medical monitoring capabilities during study startup and RFP processes, including evaluation of CVs, MMP, and investigator/site lists for vendor selection.
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 or escalating data impacting subject safety or study integrity.
6. Attend internal and joint CRO-sponsor medical monitoring safety meetings and review meeting minutes.
7. Review blinded medical coding for adverse events, serious adverse events, medications, and medical history; participate in BDRM prior to database lock and interpret efficacy and safety data after unblinding.
8. Support business development activities for respiratory programs and portfolio, including medical affairs in BD and ROW development, new initiatives, and lifecycle management programs.
9. Foster close collaboration with internal stakeholders such as Preclinical Research, Toxicology, DMPK, Regulatory, Clinical Operations, Project Management, Medical Affairs, and legal teams. Participate in advisory boards, respiratory forums, and meetings. Engage with regulators on clinical development pathways and expedite approvals.
10. Develop project strategies and evaluate new business opportunities or internal target drug candidates to expand the respiratory, allergy, and inflammation pipeline, managing programs from clinical candidate evaluation to registration.

Knowledge and Education:

Educational Qualifications:

• MD / MS
• MD with specialization in Internal and Pulmonary/Critical Care Medicine

Experience:

• Minimum of 18 years of experience as a practicing pulmonary clinical professional, with at least 5 years in the pharmaceutical industry or clinical project management, including regulatory interactions for drug development.

Knowledge and Skills (Functional / Technical):

• Drug Development
• Scientific advocacy with policymakers and regulators

Behavioral Attributes:

• Strong decision-making and influencing skills within a team environment.
• Excellent interpersonal skills.