Director/ Sr Director - Clinical Development (Pulmonology)

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

Descrizione del lavoro

An established industry player is seeking a Director/Sr Director for Clinical Development focused on Pulmonology. This pivotal role involves leading innovative drug development strategies and ensuring compliance with regulatory standards. The successful candidate will mentor teams, collaborate with global stakeholders, and drive the development of respiratory programs from evaluation to registration. With a strong emphasis on decision-making and interpersonal skills, this position offers a unique opportunity to influence the future of respiratory medicine. Join a dynamic environment where your expertise will shape the next generation of therapeutic solutions.

Competenze

• 18+ years in pulmonary clinical practice with 5+ years in pharmaceutical development.
• Strong expertise in leading clinical studies and regulatory compliance.

Mansioni

• Lead Clinical Sciences respiratory projects and ensure timely delivery.
• Review study documents and guide on subject eligibility and safety.

Conoscenze

Drug Development Expertise

Regulatory Interactions

Decision-Making Skills

Interpersonal Abilities

Formazione

MD / MS in Internal Medicine

Specialization in Pulmonary/Critical Care Medicine

Descrizione del lavoro

Here is a refined version of the job description with improved formatting and focus:

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

Client:

Location:

Job Category: Other

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EU work permit required: Yes

Job Reference: 194136563343425536337119

Job Views: 2

Posted: 08.05.2025

Job Description:

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

Role Overview:

This position leads and supports the clinical development of new drugs, focusing on innovative approaches to plan clinical studies and support end-to-end drug development in compliance with regulations and company objectives. Responsibilities include discussions with global regulators on respiratory clinical pathways, review of in-licensing respiratory molecules, and participation in ad boards and global meetings.

Job Responsibilities:

• Lead and mentor Clinical Sciences respiratory projects, ensuring timely delivery.
• Review key study documents such as protocols, consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
• Assess CRO medical monitoring capabilities during study start-up and vendor selection processes.
• Guide on subject eligibility, deviations, and safety or protocol-related questions.
• Review efficacy and safety data, including blinded analyses and SAE/SUSAR documents.
• Participate in medical monitoring safety meetings and review minutes.
• Oversee blinded medical coding and interpret efficacy and safety data post-unblinding.
• Support business development and portfolio management for respiratory programs.
• Collaborate with internal stakeholders and participate in industry forums and meetings.
• Drive strategy for respiratory program development from clinical candidate evaluation to registration.

Knowledge and Education:

Qualifications:

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

Experience:

• Minimum 18 years in pulmonary clinical practice with over 5 years in pharmaceutical/clinical development industry.

Skills and Attributes:

• Expertise in drug development and regulatory interactions.
• Strong decision-making and influencing skills, with good interpersonal abilities.