Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Verona; In loco; EUR 90.000 - 150.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a Director of Clinical Development to lead innovative drug development in pulmonology. This pivotal role involves managing clinical projects, engaging with global regulators, and supporting end-to-end drug development. The ideal candidate will have extensive experience in pulmonary clinical practice and a strong background in pharmaceutical development. Join a collaborative environment where your expertise will drive impactful respiratory programs and contribute to the advancement of healthcare solutions. If you're passionate about making a difference in patient care, this opportunity is for you.

Competenze

• 18+ years of pulmonary clinical practice with 5+ years in pharmaceutical or clinical development.
• Experience with regulatory interactions and drug development processes.

Mansioni

• Lead and mentor Clinical Sciences respiratory projects ensuring timely delivery.
• Participate in regulatory discussions and review key study documents.

Conoscenze

Drug development processes

Scientific advocacy

Regulatory engagement

Decision-making skills

Interpersonal skills

Formazione

MD / MS

MD with specialization in Internal and Pulmonary/Critical Care Medicine

Descrizione del lavoro

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

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

Overview:

This position leads and supports the clinical development of new drugs, focusing on innovative approaches to planning clinical studies and supporting end-to-end drug development in compliance with all applicable regulations and aligning with company objectives. Responsibilities include discussions with global regulators on respiratory clinical development pathways, review & due diligence of in-licensing respiratory molecules, and participation in advisory boards and global respiratory meetings.

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.
• Provide guidance on subject eligibility, deviations, and protocol-related questions to CRO and study teams.
• Review blinded efficacy and safety data, listings, tables, and address safety concerns or data impacting study integrity.
• Participate in medical monitoring safety meetings and review meeting minutes.
• Review blinded medical coding for adverse events and medications, participate in BDRM, and interpret efficacy and safety data post-unblinding.
• Support business development for respiratory programs and portfolio management, including lifecycle management and new programs.
• Collaborate with internal stakeholders across departments and participate in respiratory forums, meetings, and regulatory discussions.
• Drive project development and evaluate new business opportunities within respiratory, allergy, and inflammation pipelines, from candidate evaluation to registration.

Qualifications:

Education:

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

Experience:

• At least 18 years of pulmonary clinical practice with over 5 years in pharmaceutical or clinical development industries, including regulatory interactions.

Knowledge and Skills:

• Drug development processes
• Scientific advocacy and regulatory engagement

Behavioral Attributes:

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