Director / Sr Director - Clinical Development (Pulmonology)

JR Italy; La Spezia; In loco; EUR 80.000 - 140.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a Clinical Development Lead to spearhead innovative drug development in respiratory medicine. This role involves overseeing clinical projects from inception to approval, engaging with global regulators, and mentoring teams to ensure compliance with all regulations. The ideal candidate will have extensive experience in pulmonary medicine and a strong background in the pharmaceutical industry. If you are passionate about advancing healthcare and thrive in a collaborative environment, this opportunity is perfect for you.

Competenze

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

Mansioni

• Lead and manage Clinical Sciences respiratory projects for timely delivery.
• Review key study documents and CRO medical monitoring capabilities.
• Collaborate with internal stakeholders and engage with regulators.

Conoscenze

Drug Development

Scientific advocacy with policymakers/regulators

Decision-making

Interpersonal skills

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 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 aligning with the company's business objectives. Responsibilities include discussions with global regulators on respiratory clinical development pathways to facilitate drug approvals, review and due diligence of in-licensing respiratory molecules, and presentations at ad boards and global respiratory meetings.

Job Responsibilities

1. Lead, manage, and mentor Clinical Sciences respiratory projects to ensure timely delivery of all deliverables.
2. Contribute to and review key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
3. Review CRO medical monitoring capabilities during study start-up and RFP processes, including CVs, MMPs, and investigator/site lists for vendor selection.
4. Guide on subject eligibility, deviations, and other medical or safety questions to CRO MM, site investigators, and study teams.
5. Review blinded efficacy and safety data, listings, tables, deviations, and support review of blinded SAE or SUSAR documents, addressing any data impacting safety or study integrity.
6. Participate in internal and joint CRO-sponsor safety meetings and review meeting minutes.
7. Review blinded medical coding for AEs, SAEs, medications, and medical history; participate in BDRM prior to DBL and interpret efficacy and safety data post-unblinding.
8. Support business development for respiratory programs and portfolio, including medical affairs in BD and ROW development.
9. Collaborate with internal stakeholders across departments and participate in ad boards, respiratory forums, and meetings; engage with regulators on clinical development pathways.
10. Drive the development of projects and evaluate new business opportunities or internal drug candidates to expand the respiratory, allergy, and inflammation pipeline, overseeing strategies 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 within clinical development, including regulatory interactions for drug development.

Knowledge and Skills (Functional / Technical)

• Drug Development
• Scientific advocacy with policymakers/regulators

Behavioral Attributes

• Strong decision-making and influencing skills; good interpersonal skills.