Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Vicenza; Remoto; EUR 80.000 - 150.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a seasoned clinical professional to lead innovative drug development in respiratory medicine. This pivotal role involves overseeing clinical studies, ensuring compliance with regulations, and engaging with global regulators to facilitate drug approvals. The ideal candidate will have extensive experience in pulmonary medicine and a strong background in the pharmaceutical industry. Join a forward-thinking organization that values scientific advocacy and collaboration, and play a crucial role in advancing therapies for respiratory conditions. This is an opportunity to make a significant impact on patient care and drug development strategies.

Competenze

• Minimum 18 years of experience in pulmonary clinical practice.
• Over 5 years in pharmaceutical industry related to clinical development.

Mansioni

• Lead and manage Clinical Sciences respiratory projects.
• Review key study-related documents and provide guidance on protocols.
• Collaborate with internal stakeholders and engage with regulators.

Conoscenze

Drug Development

Scientific advocacy

Decision-making

Interpersonal skills

Formazione

MD / MS degree

Specialization in Internal and Pulmonary/Critical Care Medicine

Descrizione del lavoro

Job Description:

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 advisory boards and global respiratory meetings.

Job Responsibilities:

• Lead, manage, and mentor Clinical Sciences respiratory projects, ensuring timely delivery of all deliverables.
• Review and contribute to key study-related documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
• Review CRO medical monitoring capabilities during study startup and RFP processes, including CVs, MMP, and investigator/site lists for vendor selection.
• Provide guidance on subject eligibility, deviations, and other medical, safety, or protocol-related questions to CRO MM, site investigators, and study teams.
• 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.
• Attend internal or joint CRO-sponsor medical monitoring safety meetings and review minutes.
• Review blinded medical coding for AEs, SAEs, medications, and medical history, participate in BDRM, and interpret efficacy and safety data post-unblinding.
• Support business development for respiratory programs, portfolio, and medical affairs in BD and ROW development, including new and lifecycle management programs.
• Collaborate closely with internal stakeholders across departments and participate in ad boards, respiratory forums, and meetings. Engage with regulators on development pathways and approval processes.
• Develop projects and evaluate new business opportunities or internal drug candidates to expand the respiratory, allergy, and inflammation pipeline, driving strategy from candidate evaluation to registration.

Knowledge and Education:

Qualifications:

• MD / MS degree
• Specialization in Internal and Pulmonary/Critical Care Medicine

Experience:

• Minimum 18 years of experience as a practicing pulmonary clinical professional, with over 5 years in the pharmaceutical industry or clinical projects related to clinical development and regulatory interactions.

Knowledge and Skills:

• Drug Development
• Scientific advocacy with policymakers and regulators

Behavioral Attributes:

• Strong decision-making and influencing skills.
• Good interpersonal skills.