Director/ Sr Director - Clinical Development (Respiratory)

JR Italy; Milano; In loco; EUR 100.000 - 150.000; Tempo pieno

Descrizione del lavoro

A leading company in the pharmaceutical sector is seeking a Director/Sr Director for Clinical Development in Respiratory. The role involves leading clinical studies, engaging with global regulators, and supporting drug development strategies. Ideal candidates will have extensive experience in pulmonary medicine and drug development.

Competenze

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

Mansioni

• Lead and manage Clinical Sciences respiratory projects.
• Contribute to and review key study documents.
• Engage with regulators on development pathways.

Conoscenze

Drug Development

Scientific advocacy

Formazione

MD / MS

MD in Internal and Pulmonary/Critical Care Medicine

Descrizione del lavoro

Below is a refined version of the job description to improve clarity and formatting:

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

Client:

Location:

Job Category: Other

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EU work permit required: Yes

Job Reference:

745023147201685094433710

Job Views:

2

Posted:

16.05.2025

Expiry Date:

30.06.2025

Job Description:

Please 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. The role involves discussions with global regulators on respiratory clinical development pathways for facilitating drug approvals; review and due diligence of in-licensing respiratory molecules; and participation in advisory boards and global respiratory meetings.

Job Responsibilities:

• Lead, manage, and mentor Clinical Sciences respiratory projects to ensure timely delivery of all deliverables.
• 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 for vendor selection.
• Provide guidance on subject eligibility, deviations, and other medical, safety, or 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, addressing any data impacting subject safety or study integrity.
• Attend internal or joint CRO-sponsor safety meetings and review meeting minutes.
• Review blinded medical coding for AEs, SAEs, medications, and medical history, participate in BDRM, and interpret efficacy and safety data post-unblinding.
• Support business development for respiratory programs, including portfolio management, medical affairs, and lifecycle management.
• Collaborate with internal stakeholders across departments and participate in advisory boards, forums, and presentations. Engage with regulators on development pathways and approval processes.
• Develop projects and evaluate new business opportunities or internal drug candidates to expand the respiratory, allergy, and inflammation pipeline, driving clinical 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 practicing pulmonary clinical professional experience, with over 5 years in the pharmaceutical industry or clinical projects in drug 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.