Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Savona; In loco; EUR 90.000 - 150.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a dynamic Director/Sr Director of Clinical Development to lead innovative drug development in the pulmonology space. This pivotal role involves managing clinical projects, mentoring teams, and engaging with global regulators to ensure compliance and successful drug approval. The ideal candidate will possess extensive experience in pulmonary medicine and a proven track record in the pharmaceutical industry. Join a forward-thinking organization dedicated to advancing healthcare solutions and making a significant impact on patient outcomes.

Competenze

• 18+ years of experience in pulmonary clinical practice and regulatory interactions.
• Strong background in drug development and clinical study planning.

Mansioni

• Lead clinical development projects ensuring timely delivery of milestones.
• Collaborate with regulators on drug approval pathways and participate in global meetings.

Conoscenze

Drug Development

Scientific advocacy

Decision-making

Interpersonal skills

Formazione

MD / MS

MD in Internal and Pulmonary/Critical Care Medicine

Descrizione del lavoro

The current job description has some formatting issues and could benefit from clearer structure and consistency. Here is a refined version:

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

Client:

Location:

Job Category: Other

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EU work permit required: Yes

Job Reference: 194136563343425536337170

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, conceive 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. Responsibilities include discussions with global regulators on respiratory clinical development pathways for drug approval, review and due diligence of in-licensing respiratory molecules, and participation in ad boards and global respiratory meetings.

Job Responsibilities:

• Lead, manage, and mentor Clinical Sciences respiratory projects ensuring timely delivery of all milestones.
• 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.
• Provide guidance on subject eligibility, deviations, and protocol-related questions to CRO MM, site investigators, and study teams.
• Review blinded efficacy and safety data, listings, tables, deviations, and support review of SAE or SUSAR documents, addressing any data impacting safety or integrity.
• Attend internal and joint CRO-sponsor safety meetings and review minutes.
• Review blinded medical coding for AEs, SAEs, medications, and medical history, and interpret efficacy and safety data post-unblinding.
• Support business development for respiratory programs and portfolio management, including lifecycle management programs.
• Collaborate with internal stakeholders across departments and participate in ad boards, forums, and meetings. Engage with regulators on clinical pathways and approval processes.
• Evaluate new business opportunities and internal drug candidates to expand the respiratory, allergy, and inflammation pipeline, driving 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.