Director/ Sr Director - Clinical Development (Pulmonology)

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

Descrizione del lavoro

An innovative firm is seeking a seasoned professional to lead clinical development in respiratory drug projects. This role involves strategic oversight of clinical studies, regulatory discussions, and collaboration with various stakeholders. The ideal candidate will have extensive experience in pulmonary medicine and drug development, ensuring compliance with regulations while driving projects from inception to approval. Join a dynamic team focused on advancing healthcare solutions and making a significant impact in the pharmaceutical industry.

Competenze

• 18+ years of experience in pulmonary clinical practice and drug development.
• Strong background in regulatory interactions and clinical project management.

Mansioni

• Lead and mentor Clinical Sciences respiratory projects for timely deliverables.
• Review key study documents and CRO medical monitoring capabilities.

Conoscenze

Drug Development

Scientific advocacy with policymakers/regulators

Decision-making skills

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 lead and support 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. 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 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 startup and RFP processes, including CVs, MMPs, and investigator/site lists for vendor selection.
• Provide guidance on subject eligibility, deviations, and other medical or protocol-related questions to CRO medical monitors, site investigators, and study teams.
• Review blinded efficacy and safety data, listings, tables, deviations, and support review of blinded SAE or SUSAR documents, addressing any data impacting subject safety or study integrity.
• Participate in internal or joint CRO-sponsor medical monitoring safety meetings and review meeting minutes.
• Review blinded medical coding for adverse events, serious adverse events, medications, and medical history; participate in BDRM prior to database lock and interpret efficacy and safety data post-unblinding.
• Support business development for respiratory programs, portfolio, and medical affairs, including new and lifecycle management programs.
• Collaborate closely with internal stakeholders (Preclinical Research, Toxicology, DMPK, Regulatory, ClinOps, Project Management, Medical Affairs, Legal, etc.), participate in advisory boards, forums, and presentations, and engage with regulators on clinical development pathways.
• Develop projects and evaluate new business opportunities or internal target drug candidates to expand the respiratory, allergy, and inflammation pipeline, driving strategy and 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 in drug development, including regulatory interactions.

Knowledge and Skills (Functional / Technical)

• Drug Development
• Scientific advocacy with policymakers/regulators

Behavioral Attributes

• Strong decision-making and influencing skills, with good interpersonal skills.