Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Catania; In loco; EUR 80.000 - 150.000; Tempo pieno

Descrizione del lavoro

An innovative firm is seeking a Director of Clinical Development specializing in pulmonology. This role involves leading clinical studies, ensuring compliance with regulations, and collaborating with global regulators. The ideal candidate will have extensive experience in drug development and a strong background in pulmonary medicine. This position offers an exciting opportunity to influence the development of new therapies in respiratory health, working alongside a dynamic team dedicated to advancing patient care. If you are passionate about clinical excellence and have a proven track record in the pharmaceutical industry, this role is for you.

Competenze

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

Mansioni

• Lead and manage Clinical Sciences respiratory projects.
• Review key study documents and assess CRO capabilities.
• Collaborate with stakeholders and participate in regulatory discussions.

Conoscenze

Drug Development expertise

Scientific advocacy with policymakers and regulators

Strong decision-making skills

Excellent interpersonal skills

Formazione

MD / MS with specialization in Internal Medicine

Specialization in Pulmonary/Critical Care Medicine

Descrizione del lavoro

Director/ Sr Director - Clinical Development (Pulmonology), Catania

This position is open to candidates based anywhere in Europe or the US.

Role Overview:

The role involves heading and supporting the clinical development of new drugs, including planning clinical studies and supporting end-to-end drug development in compliance with regulations and aligned with company objectives. It includes discussions with global regulators on respiratory clinical development pathways, 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 milestones.
• 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.
• Guide on subject eligibility, deviations, and protocol-related questions to CRO and study teams.
• Review blinded efficacy and safety data, address issues impacting subject safety or study integrity.
• Attend safety meetings and review medical meeting minutes.
• Oversee blinded medical coding and interpret efficacy and safety data post-unblinding.
• Support business development and portfolio management for respiratory programs, including new and lifecycle management projects.
• Collaborate with internal stakeholders across departments and participate in industry forums and regulatory discussions.
• Develop projects and evaluate new business opportunities to expand the respiratory, allergy, and inflammation pipeline, from candidate evaluation to registration.

Knowledge and Education:

Qualifications:

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

Experience:

• At least 18 years as a practicing pulmonary clinical professional, with over 5 years in the pharmaceutical industry or clinical project management, including regulatory interactions.

Skills:

• Drug Development expertise
• Scientific advocacy with policymakers and regulators

Behavioral Attributes:

• Strong decision-making and team influence skills.
• Excellent interpersonal skills.