Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Ancona; Remoto; EUR 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

An innovative firm is seeking a Director/Sr Director in Clinical Development to lead the clinical strategies for groundbreaking respiratory drugs. This pivotal role involves collaborating with global regulators, mentoring teams, and ensuring the successful delivery of clinical projects. With a focus on drug development and regulatory interactions, the right candidate will have significant experience in pulmonary medicine and a strong background in clinical research. Join a forward-thinking organization where your expertise will directly influence the future of respiratory health and drug approval processes.

Competenze

• Minimum 18 years of experience in pulmonary clinical practice.
• Over 5 years in pharmaceutical clinical development and regulatory interactions.

Mansioni

• Lead and manage Clinical Sciences respiratory projects.
• Review key study documents and assess CRO medical monitoring capabilities.
• Collaborate with internal stakeholders and develop new business opportunities.

Conoscenze

Drug Development

Scientific advocacy with policymakers/regulators

Decision-making skills

Interpersonal skills

Formazione

MD / MS

MD in Internal and Pulmonary/Critical Care Medicine

Descrizione del lavoro

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

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Job Category:

Other

EU work permit required:

Yes

Job Reference:

194136563343425536337131

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 aligning with the company's business objectives. Responsibilities include discussions with global regulators on respiratory clinical development pathways for drug approval facilitation, review & 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 objectives.
2. Review key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
3. Assess CRO medical monitoring capabilities during study start-up and RFP processes, including CVs, MMP, and investigator/site lists.
4. Provide guidance on subject eligibility, deviations, and related questions to CRO MM, site investigators, and study teams.
5. Review blinded efficacy and safety data, listings, tables, deviations, and support review of SAE or SUSAR documents, addressing issues impacting safety or study integrity.
6. Participate in medical monitoring safety meetings and review meeting minutes.
7. Review blinded medical coding for adverse events and medications, participate in BDRM prior to database lock, and interpret efficacy and safety data after unblinding.
8. Support business development for respiratory programs and portfolio, including new and lifecycle management programs.
9. Collaborate with internal stakeholders across departments and participate in ad boards, forums, and meetings with regulators.
10. Develop projects and evaluate new business opportunities to expand the respiratory, allergy, and inflammation pipeline, leading the strategy 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 pharmaceutical clinical 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.