Director/ Sr Director - Clinical Development (Pulmonology)

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

Descrizione del lavoro

An established industry player is seeking a Clinical Development Lead to spearhead the clinical development of innovative respiratory drugs. This pivotal role involves managing projects, mentoring teams, and engaging with global regulators to streamline drug approvals. The ideal candidate will have extensive experience in pulmonary medicine and a strong background in the pharmaceutical industry. Join a dynamic environment where your expertise will drive the development of life-changing therapies, ensuring timely and effective solutions for respiratory health. This is an exciting opportunity to make a significant impact in the field of drug development.

Competenze

• Minimum 18 years of experience as a practicing pulmonary clinical professional.
• Over 5 years in the pharmaceutical industry or clinical project development.

Mansioni

• Lead and mentor Clinical Sciences respiratory projects.
• Review key study documents and provide guidance on medical questions.
• Collaborate with internal stakeholders across various departments.

Conoscenze

Drug Development

Scientific advocacy with policymakers and regulators

Formazione

MD / MS in a relevant field

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, including planning clinical studies and supporting end-to-end drug development in accordance with all applicable regulations and aligning 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 ad boards and global respiratory meetings.

Job Responsibilities

• Lead, manage, and mentor Clinical Sciences respiratory projects, ensuring timely delivery of all tasks.
• Review and contribute to key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
• Assess CRO medical monitoring capabilities during study startup and RFP processes, including review of CVs, MMP, and investigator/site lists for vendor selection.
• Provide guidance on subject eligibility, deviations, and other medical or safety-related questions to CRO MM, site investigators, and study teams.
• Review blinded efficacy and safety data, including 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 safety meetings and review meeting minutes.
• Review blinded medical coding for adverse events, serious adverse events, medications, and medical history, and interpret efficacy and safety data post-unblinding.
• Support business development for respiratory programs and portfolio, including medical affairs and lifecycle management programs.
• Collaborate with internal stakeholders across departments such as Preclinical Research, Toxicology, DMPK, Regulatory, ClinOps, Project Management, Medical Affairs, and Legal.
• Participate in ad boards, respiratory forums, and meetings; engage with regulators on clinical development pathways for faster approvals.
• Develop projects and evaluate new business opportunities or internal drug candidates to expand the respiratory, allergy, and inflammation pipeline, driving strategy from candidate evaluation to registration.

Knowledge and Education

Qualifications:

• MD / MS in a relevant field
• 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 project development, including regulatory interactions.

Knowledge and Skills

• Drug Development
• Scientific advocacy with policymakers and regulators

Behavioral Attributes

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