Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Biella; Remoto; EUR 80.000 - 120.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a seasoned leader in clinical development to spearhead innovative drug projects in respiratory medicine. This role is pivotal in guiding clinical studies and ensuring compliance with regulations while collaborating with global stakeholders. The ideal candidate will leverage extensive experience in pulmonary medicine and drug development to influence strategic decisions and drive successful outcomes. If you are passionate about advancing healthcare through innovative solutions and have a proven track record in clinical project leadership, this opportunity is tailor-made for you.

Competenze

• 18+ years as a pulmonary clinical professional with 5+ years in pharma.
• Expertise in drug development and regulatory interactions.

Mansioni

• Lead and mentor Clinical Sciences respiratory projects.
• Contribute to and review key study documents and protocols.
• Engage with regulators on clinical development pathways.

Conoscenze

Drug Development

Scientific advocacy with policymakers/regulators

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 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 & due diligence of in-licensing respiratory molecules, and presentation in ad boards and global respiratory meetings.

Job Responsibilities

• Lead, manage, and mentor Clinical Sciences respiratory projects, ensuring timely delivery of all deliverables. Responsibilities may include, but are not limited to:
• Contributing to and reviewing key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
• Reviewing CRO medical monitoring capabilities during study startup and RFP processes, including CVs, MMP, and investigator/site lists for vendor selection.
• Providing guidance on subject eligibility, deviations, and other medical, safety, or protocol-related questions to CRO MM, site investigators, and study teams.
• Reviewing blinded efficacy and safety data, listings, tables, deviations, and supporting review of blinded SAE or SUSAR documents, addressing data impacting subject safety or study integrity.
• Attending internal or joint CRO-sponsor safety meetings and reviewing medical meeting minutes.
• Reviewing blinded medical coding for AEs, SAEs, medications, and medical history, participating in BDRM prior to DBL, and interpreting efficacy and safety data after unblinding.
• Supporting business development for respiratory programs, portfolio, medical affairs, and lifecycle management, including new programs.
• Building and maintaining collaboration with internal stakeholders (Preclinical Research, Toxicology, DMPK, Regulatory, ClinOps, Project Management, Medical Affairs, legal, others). Participating in ad boards, respiratory forums, and meetings, and engaging with regulators on development pathways.
• Developing projects and evaluating new business opportunities or internal target drug candidates to expand the respiratory, allergy, and inflammation pipeline, driving strategy 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 related to clinical development and regulatory interactions.

Knowledge and Skills (Functional / Technical)

• Drug Development
• Scientific advocacy with policymakers/regulators

Behavioral Attributes

• Strong decision-making and influencing skills within a team environment. Good interpersonal skills are essential.