Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Latina; 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 role involves guiding clinical studies, engaging with global regulators, and mentoring teams to ensure timely project delivery. The ideal candidate will have extensive experience in pulmonary medicine and a strong background in the pharmaceutical industry. Join a dynamic environment where your expertise will directly contribute to advancing healthcare solutions and improving patient outcomes. If you are passionate about making a difference in the field of drug development, this opportunity is perfect for you.

Competenze

• Minimum 18 years of experience in pulmonary clinical practice.
• Over 5 years in pharmaceutical industry or clinical project management.

Mansioni

• Lead and mentor Clinical Sciences respiratory projects.
• Review key study documents and provide guidance on protocols.
• Support business development for respiratory programs.

Conoscenze

Drug Development

Scientific advocacy with policymakers/regulators

Decision-making

Interpersonal skills

Formazione

MD / MS

MD 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 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 and contribute to key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
• Assess CRO medical monitoring capabilities during study start-up 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, listings, tables, deviations, and support safety-related document reviews.
• 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, portfolio, and lifecycle management.
• Collaborate with internal stakeholders across departments and participate in industry 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:

Educational Qualifications:

• MD / MS
• MD 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 project management, including regulatory interactions.

Knowledge and Skills:

• Drug Development
• Scientific advocacy with policymakers/regulators

Behavioral Attributes:

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