Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Chieti; In loco; EUR 100.000 - 200.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a Director/Sr Director for Clinical Development in Pulmonology. This pivotal role involves leading innovative clinical studies and collaborating with global regulators to drive drug development. The ideal candidate will have extensive experience in pulmonary medicine and a strong background in the pharmaceutical sector. You will be responsible for mentoring teams, reviewing critical study documents, and guiding strategic business development initiatives. Join a forward-thinking company dedicated to advancing respiratory health and making a significant impact in the field.

Competenze

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

Mansioni

• Lead and mentor Clinical Sciences respiratory projects.
• Review key study documents and provide guidance on subject eligibility.
• Support business development for respiratory programs.

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

The provided job description has a good structure but requires some formatting and content improvements for clarity and professionalism. Here is a refined version:

Director / Sr Director - Clinical Development (Pulmonology), Chieti

Client:

Location:

Job Category: Other

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EU work permit required: Yes

Job Reference:

194136563343425536337164

Job Views:

2

Posted:

08.05.2025

Job Description:

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

Role Overview:

This position is intended to head 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, 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.
• 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, MMP, and investigator/site lists.
• 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, listings, tables, deviations, and support the review of blinded SAE or SUSAR documents, addressing any data impacting subject safety or study integrity.
• Attend internal or joint CRO-sponsor medical monitoring safety meetings and review minutes.
• Review blinded medical coding for AEs, SAEs, 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 across departments and participate in ad hoc meetings and forums.
• Develop projects and evaluate new business opportunities to expand the respiratory, allergy, and inflammation pipeline, driving strategy from clinical 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.