Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Perugia; Remoto; EUR 80.000 - 150.000; 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 ensuring compliance with regulations. The successful candidate will collaborate with global regulators and internal teams to drive drug development, focusing on respiratory therapies. With a strong emphasis on mentorship and project management, this position offers an exciting opportunity to shape the future of respiratory medicine. If you have a passion for advancing healthcare and a wealth of experience in clinical development, this role is perfect for you.

Competenze

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

Mansioni

• Lead and mentor clinical projects, ensuring timely delivery of milestones.
• Engage with regulators and support drug development pathways.

Conoscenze

Drug Development

Scientific advocacy with policymakers/regulators

Formazione

MD / MS

MD in Internal and Pulmonary/Critical Care Medicine

Descrizione del lavoro

The provided job description contains valuable information but requires improvements in formatting, clarity, and focus to enhance readability and professionalism. Below is a refined version with better structure and presentation, using only the permitted HTML tags:

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

Client: [Client Name]

Location: Perugia, Italy

Job Category: Other

EU work permit required: Yes

Job Reference: 194136563343425536337137

Job Views: 2

Posted: 08.05.2025

Job Description

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

Role Overview: This position leads and supports the clinical development of new drugs, focusing on innovative approaches to planning clinical studies and supporting end-to-end drug development in compliance with all applicable regulations, 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 ad 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 start-up and RFP processes, including CVs, MMP, and investigator/site lists.
• Provide guidance on subject eligibility, deviations, and protocol-related questions to CRO MM, site investigators, and study teams.
• Review blinded efficacy and safety data, listings, tables, deviations, and support review of blinded SAE or SUSAR documents, escalating any data impacting safety or integrity.
• Attend internal and joint CRO-sponsor safety meetings and review minutes.
• Review blinded medical coding for AEs, SAEs, medications, and medical history, and interpret efficacy and safety data post-unblinding.
• Support business development for respiratory programs and portfolio management, including new and lifecycle management projects.
• Collaborate with internal stakeholders across departments and participate in ad boards and respiratory forums.
• Engage with regulators on clinical development pathways for faster approvals.
• Develop projects and evaluate new business opportunities to expand the respiratory, allergy, and inflammation pipeline, overseeing programs 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 involving regulatory interactions for drug development.

Knowledge and Skills

• Drug Development
• Scientific advocacy with policymakers/regulators

Behavioral Attributes

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