Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Rovigo; Remoto; EUR 90.000 - 150.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a seasoned clinical leader to head the respiratory drug development team. This pivotal role involves managing clinical projects, collaborating with global regulators, and driving innovative strategies for drug approvals. The ideal candidate will possess extensive experience in pulmonary medicine and a strong background in clinical development within the pharmaceutical sector. Join a forward-thinking organization committed to advancing healthcare solutions and making a significant impact in respiratory medicine.

Competenze

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

Mansioni

• Lead and mentor Clinical Sciences respiratory projects.
• Review key study documents and assess CRO medical monitoring capabilities.
• Collaborate with internal stakeholders and participate in respiratory forums.

Conoscenze

Drug Development expertise

Scientific advocacy with policymakers and regulators

Strong decision-making skills

Good interpersonal skills

Formazione

MD or MS degree

Specialization in Internal Medicine 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 aligned with the company's business objectives. Responsibilities include 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 objectives.
• Review key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
• Assess CRO medical monitoring capabilities during study startup and vendor selection processes.
• Provide guidance on subject eligibility, deviations, and protocol-related questions to CRO and site staff.
• Review blinded efficacy and safety data, including listings, tables, deviations, and address any data impacting subject safety or study integrity.
• Participate in internal and joint CRO-sponsor safety meetings and review minutes.
• Review blinded medical coding for adverse events and medications, and interpret efficacy and safety data post-unblinding.
• Support business development for respiratory programs and portfolio management, including lifecycle management programs.
• Collaborate with internal stakeholders across departments and participate in respiratory forums and meetings.
• Develop projects and evaluate new business opportunities to expand the respiratory, allergy, and inflammation pipeline, driving strategy from clinical candidate evaluation to registration.

Knowledge and Education:

Qualifications:

• MD or MS degree
• Specialization in Internal Medicine 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 development projects, including regulatory interactions.

Knowledge and Skills:

• Drug Development expertise
• Scientific advocacy with policymakers and regulators

Behavioral Attributes:

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