Director/ Sr Director - Clinical Development (Respiratory)

JR Italy; La Spezia; Remoto; EUR 80.000 - 150.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a skilled leader in clinical development to drive respiratory drug projects. This role encompasses planning and executing clinical studies while ensuring compliance with regulations. The position requires extensive experience in pulmonary medicine and drug development, along with strong decision-making and interpersonal skills. This is an exciting opportunity to influence the future of respiratory therapies and engage with global regulators. Join a dynamic team that values innovation and collaboration in the healthcare sector.

Competenze

• 18 years of clinical pulmonary practice required.
• 5 years in pharmaceutical or clinical development projects.

Mansioni

• Lead and mentor Clinical Sciences respiratory projects.
• Review study documents and assess CRO capabilities.
• Support business development for respiratory programs.

Conoscenze

Drug development expertise

Scientific advocacy

Regulatory engagement skills

Formazione

MD / MS in Internal Medicine

Specialization in Pulmonary/Critical Care Medicine

Descrizione del lavoro

The provided job description contains a comprehensive overview of the role, responsibilities, and requirements. However, its formatting can be improved for better readability and engagement by properly structuring the content with HTML tags. Additionally, some sections could be condensed or clarified for conciseness and focus. Here is a refined version:

Job Description

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

Role Overview

This position is responsible for leading and supporting the clinical development of new drugs, including planning clinical studies and supporting end-to-end drug development in accordance with all applicable regulations and company objectives. The role involves discussions with global regulators on respiratory clinical development pathways for drug approvals, reviewing in-licensing respiratory molecules, and participating in 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 start-up and vendor selection processes.
• Provide guidance on subject eligibility, deviations, and protocol-related questions to CRO and site teams.
• Review blinded efficacy and safety data, and support safety monitoring and data integrity.
• Participate in medical monitoring safety meetings and review related documentation.
• Support business development and portfolio management for respiratory programs, including lifecycle management.
• Collaborate with internal stakeholders across departments and participate in industry forums and meetings.
• Evaluate new business opportunities and drive strategy from clinical candidate evaluation to registration.

Knowledge and Education

Qualifications:

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

Experience:

• Minimum of 18 years of clinical pulmonary practice, including at least 5 years in pharmaceutical or clinical development projects, with regulatory interaction experience.

Skills:

• Drug development expertise.
• Scientific advocacy and regulatory engagement skills.

Behavioral Attributes

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