Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Roma; In loco; EUR 80.000 - 130.000; Tempo pieno

Descrizione del lavoro

An innovative firm is seeking a Clinical Development Lead to spearhead the advancement of respiratory drug development. This pivotal role involves guiding clinical projects, collaborating with global regulators, and ensuring compliance with all regulations. The ideal candidate will possess extensive experience in pulmonary medicine and drug development, demonstrating strong decision-making and interpersonal skills. Join a dynamic team focused on expanding the respiratory pipeline and driving strategic initiatives from clinical evaluation to registration. This opportunity is perfect for those passionate about making a significant impact in the pharmaceutical industry.

Competenze

• 18+ years of experience in pulmonary clinical roles with 5+ years in pharma.
• Expertise in drug development and regulatory interactions.

Mansioni

• Lead and mentor Clinical Sciences respiratory projects for timely deliverables.
• Review key study documents and CRO medical monitoring capabilities.

Conoscenze

Drug Development

Scientific advocacy with policymakers/regulators

Strong decision-making skills

Excellent interpersonal skills

Formazione

MD / MS degree

MD in Internal and Pulmonary/Critical Care Medicine

Descrizione del lavoro

Job Description

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. 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:

1. Lead, manage, and mentor Clinical Sciences respiratory projects, ensuring 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.
4. Provide guidance on subject eligibility, deviations, and other medical or protocol-related 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 or joint CRO-sponsor medical monitoring safety meetings and review minutes.
7. Review blinded medical coding for AEs, SAEs, medications, and medical history, 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 closely with internal stakeholders and participate in ad boards, forums, and meetings related to respiratory development pathways and approvals.
10. Develop projects and evaluate new business opportunities or internal drug candidates to expand the respiratory, allergy, and inflammation pipeline, driving strategy from clinical evaluation to registration.

Knowledge and Education:

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

Experience:

• Minimum 18 years of experience as a pulmonary clinical professional, with over 5 years in the pharmaceutical industry or clinical projects involving drug development and regulatory interactions.

Knowledge and Skills:

• Drug Development
• Scientific advocacy with policymakers/regulators

Behavioral Attributes:

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