Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Ferrara; Remoto; EUR 100.000 - 200.000; Tempo pieno

Descrizione del lavoro

An innovative company is seeking a Director/Sr Director for Clinical Development in Pulmonology. This pivotal role involves leading clinical projects, managing drug development processes, and engaging with global regulators to facilitate drug approvals. The ideal candidate will possess extensive experience in pulmonary medicine and a strong background in the pharmaceutical industry. This position offers the opportunity to shape the future of respiratory therapies while working in a collaborative environment that values strategic insights and scientific advocacy. If you're ready to make a significant impact in drug development, this role is for you.

Competenze

• Minimum 18 years of experience in pulmonary clinical practice.
• Over 5 years in pharmaceutical industry drug development.

Mansioni

• Lead clinical sciences respiratory projects to ensure timely milestone delivery.
• Collaborate with stakeholders and engage with regulators on clinical pathways.

Conoscenze

Drug Development

Scientific advocacy

Decision-making

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), Ferrara

Job Details

Client: [Not specified]

Location: [Not specified]

Job Category: Other

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EU work permit required: Yes

Job Reference: 194136563343425536337133

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 aligned with the company's business objectives. Responsibilities include 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 ad boards and global respiratory meetings.

Job Responsibilities:

• Lead, manage, and mentor Clinical Sciences respiratory projects to ensure 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 other medical 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 SAE or SUSAR documents, addressing any data impacting safety or study integrity.
• Attend internal or joint medical monitoring safety meetings and review minutes.
• Review blinded medical coding for adverse events, concomitant medications, and medical history, participating in BDRM prior to database lock and interpreting efficacy and safety post-unblinding.
• Support business development for respiratory programs and portfolio, including medical affairs in BD and ROW development, lifecycle management, and new programs.
• Collaborate with internal stakeholders across various departments and participate in ad boards, forums, and meetings, engaging with regulators on clinical pathways and approvals.
• Develop projects and evaluate new business opportunities or 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 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.
• Good interpersonal skills.