Director/ Sr Director - Clinical Development (Respiratory)

JR Italy; Bologna; Remoto; EUR 90.000 - 150.000; Tempo pieno

Descrizione del lavoro

An established industry player seeks a Director/Sr Director for Clinical Development in Respiratory. This pivotal role involves leading clinical studies, ensuring compliance with regulations, and fostering innovative drug development strategies. The ideal candidate will have extensive experience in pulmonary medicine and a strong background in the pharmaceutical sector, driving projects from candidate evaluation to registration. Join a dynamic team where your expertise will shape the future of respiratory therapies and contribute to meaningful advancements in patient care across Europe and the US.

Competenze

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

Mansioni

• Lead and manage Clinical Sciences respiratory projects ensuring timely delivery.
• Contribute to and review key study documents such as protocols and informed consents.
• Collaborate with internal stakeholders and participate in ad boards and forums.

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

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Director/ Sr Director - Clinical Development (Respiratory), Pavia

Client:

Location:

Job Category:

Other

EU work permit required:

Yes

Job Reference:

745023147201685094433713

Job Views:

2

Posted:

02.05.2025

Expiry Date:

16.06.2025

Job Description:

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

Role Overview:

This position is intended to lead 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. It involves discussions with global regulators on respiratory clinical development pathways, 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 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, MMP, and investigator/site lists.
4. Provide guidance on subject eligibility, deviations, and other medical, safety, 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 integrity.
6. Attend internal or joint CRO-sponsor safety meetings and review minutes.
7. Review blinded medical coding for AEs, SAEs, medications, and medical history, and interpret efficacy and safety data after unblinding.
8. Support business development for respiratory programs and portfolio, including medical affairs in BD and ROW development.
9. Collaborate with internal stakeholders across various departments and participate in ad boards, forums, and meetings.
10. Develop projects and evaluate new business opportunities or internal drug candidates for pipeline expansion and business growth, 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 in development, including 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.