Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Palermo; Ibrido; EUR 80.000 - 150.000; Tempo pieno

Descrizione del lavoro

An innovative firm is seeking a Director/Sr. Director for Clinical Development in Pulmonology. This pivotal role involves leading the clinical development of cutting-edge respiratory drugs, engaging with global regulators, and overseeing clinical studies from inception to completion. The ideal candidate will possess extensive experience in pulmonary medicine and a strong background in the pharmaceutical industry. Join this dynamic environment where your expertise will drive advancements in respiratory healthcare across Europe and the US.

Competenze

• 18+ years in pulmonary clinical practice with 5+ years in pharma or clinical project management.
• Experience with regulatory interactions and drug development processes.

Mansioni

• Lead and mentor clinical projects, ensuring timely milestone delivery.
• Review study documents and provide guidance on subject eligibility.

Conoscenze

Drug Development

Scientific advocacy

Decision-making skills

Interpersonal skills

Formazione

MD / MS

Specialization in Internal and Pulmonary/Critical Care Medicine

Descrizione del lavoro

Below is a refined version of the original job description with improved formatting, clarity, and focus.

Director/Sr. Director - Clinical Development (Pulmonology), Palermo

Client: [Client details not provided]

Location: Palermo, Italy (or remote within Europe or the US)

Job Category: Other

EU work permit required: Yes

Job Reference: 194136563343425536337141

Job Views: 2

Posted: 08.05.2025

Job Description

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

Role Overview

This position leads and supports the clinical development of new respiratory drugs, focusing on innovative approaches to planning clinical studies and supporting end-to-end drug development in compliance with all applicable regulations. The role involves discussions with global regulators on respiratory clinical development pathways, 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 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 RFP processes, including review of CVs, MMP, and investigator/site lists.
• Provide guidance on subject eligibility, deviations, and protocol-related questions to CROs, site investigators, and study teams.
• Review blinded efficacy and safety data, listings, tables, deviations, and escalate any data impacting subject safety or study integrity.
• Participate in safety meetings and review medical monitoring minutes.
• Review blinded medical coding for adverse events and medical history, and interpret efficacy and safety data post-unblinding.
• Support business development for respiratory programs, including portfolio management and lifecycle strategies.
• Collaborate with internal stakeholders across departments and participate in industry forums and regulatory discussions.
• Drive the development of new projects and evaluate business opportunities to expand the respiratory pipeline, from candidate selection to registration.

Knowledge and Education

Educational Qualifications:

• MD / MS
• Specialization in Internal and Pulmonary/Critical Care Medicine

Experience:

• Minimum 18 years of experience as a pulmonary clinical professional, with at least 5 years in the pharmaceutical industry or clinical project management, including regulatory interactions.

Knowledge and Skills

• Drug Development
• Scientific advocacy with policymakers and regulators

Behavioral Attributes

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