Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Lecce; Remoto; EUR 120.000 - 200.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a Director/Sr Director for Clinical Development in Pulmonology to lead innovative drug development initiatives. This role involves managing clinical studies, collaborating with global regulators, and mentoring teams to ensure timely project delivery. With a focus on respiratory health, the successful candidate will drive strategy from clinical candidate evaluation to registration, making significant contributions to the advancement of new therapies. If you're passionate about making a difference in the pharmaceutical landscape, this opportunity is perfect for you.

Competenze

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

Mansioni

• Lead and manage Clinical Sciences respiratory projects.
• Review key study documents and assess CRO capabilities.
• Collaborate with internal stakeholders and engage with regulators.

Conoscenze

Drug Development

Scientific advocacy with policymakers/regulators

Strong decision-making

Interpersonal skills

Formazione

MD / MS

MD in Internal and Pulmonary/Critical Care Medicine

Descrizione del lavoro

Below is a refined version of the job description, with improved formatting and clarity:

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

Client:

Location:

Job Category: Other

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EU work permit required: Yes

Job Reference:

194136563343425536337152

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 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, ensuring timely delivery of all deliverables.
• Review key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
• Assess CRO medical monitoring capabilities during study start-up and RFP processes, including reviewing CVs, MMP, and investigator/site lists.
• 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 the review of blinded SAE or SUSAR documents, addressing any data impacting subject safety or study integrity.
• Participate in internal or joint CRO-sponsor medical monitoring 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, portfolio, and medical affairs in BD and ROW development, including lifecycle management programs.
• Collaborate with internal stakeholders across departments, participate in ad boards, respiratory forums, and meetings, and engage with regulators on clinical development pathways.
• Evaluate new business opportunities and internal drug candidates for pipeline expansion, driving strategy from clinical 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 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.