Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Livorno; Remoto; EUR 80.000 - 150.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a seasoned professional to lead clinical development for respiratory drugs. This role involves strategic planning and collaboration with global regulators to facilitate drug approvals. The ideal candidate will have extensive experience in pulmonary medicine and a strong background in drug development, ensuring the successful delivery of clinical projects. Join a dynamic team focused on innovative approaches to drug development, where your expertise will drive the future of respiratory therapies and improve patient outcomes.

Competenze

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

Mansioni

• Lead and mentor Clinical Sciences respiratory projects.
• Review key study documents and provide medical guidance.
• Collaborate with internal stakeholders and engage with regulators.

Conoscenze

Drug Development

Scientific advocacy with policymakers/regulators

Strong decision-making skills

Good interpersonal skills

Formazione

MD / MS

MD in Internal and Pulmonary/Critical Care Medicine

Descrizione del lavoro

Job Description

Note: The 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, focusing on innovative approaches to planning clinical studies and supporting end-to-end drug development in accordance with all applicable regulations and aligned with the company's business objectives. The role involves 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 deliverables.
• Contribute to and review key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
• Review CRO medical monitoring capabilities during study start-up and RFP processes, including CVs, MMP, and investigator/site lists.
• Provide guidance on subject eligibility, deviations, and other medical, safety, or protocol-related questions to CRO MM, site investigators, and study teams.
• Review blinded efficacy and safety data, listings, tables, deviations, and support review of blinded SAE or SUSAR documents, addressing or escalating data impacting subject safety or study integrity.
• Attend internal or joint CRO-sponsor safety meetings and review meeting minutes.
• Review blinded medical coding for AEs, SAEs, medications, and medical history, and participate in BDRM prior to DBL, providing primary interpretation after unblinding.
• Support business development for respiratory programs and portfolio, including medical affairs in BD and ROW development, new initiatives, and lifecycle management programs.
• Collaborate closely with internal stakeholders across various departments and participate in ad boards, forums, and meetings. Engage with regulators on clinical pathways and approval processes.
• Develop projects and evaluate new business opportunities or internal drug candidates to expand the respiratory, allergy, and inflammation pipeline, driving strategy and program delivery from 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 projects involving drug development and regulatory interactions.

Knowledge and Skills (Functional / Technical)

• Drug Development
• Scientific advocacy with policymakers/regulators

Behavioral Attributes

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