Director/ Sr Director - Clinical Development (Pulmonology)

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

Descrizione del lavoro

An established industry player is seeking a seasoned professional to lead clinical development for innovative respiratory drugs. This role involves managing projects, mentoring teams, and collaborating with global regulators to streamline drug approvals. With a focus on scientific advocacy and strategic development, you'll play a crucial role in expanding the company's respiratory pipeline. If you have a strong background in pulmonary medicine and a passion for drug development, this opportunity offers a chance to make a significant impact in the field.

Competenze

• 18+ years of experience in pulmonary clinical practice and 5+ years in pharmaceutical industry.
• Strong decision-making and influencing skills with good interpersonal skills.

Mansioni

• Lead and mentor Clinical Sciences respiratory projects ensuring timely delivery.
• Review key study documents and provide guidance on subject eligibility and deviations.

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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Job Reference:

194136563343425536337136

Job Views:

2

Posted:

08.05.2025

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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, including conception of 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 & 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. Responsibilities may include reviewing key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
2. Review CRO medical monitoring capabilities during study start-up and RFP processes, including CVs, MMP, and investigator/site lists for vendor selection.
3. Provide guidance on subject eligibility, deviations, and other medical, safety, or protocol-related questions to CRO MM, site investigators, and study teams.
4. Review blinded efficacy and safety data, listings, tables, deviations, and support review of blinded SAE or SUSAR documents, addressing data impacting subject safety or study integrity.
5. Attend internal or joint CRO-sponsor medical monitoring safety meetings and review minutes.
6. Review blinded medical coding for AEs, SAEs, medications, and medical history, participate in BDRM, and interpret efficacy and safety data post-unblinding.
7. Support business development for respiratory programs and portfolio, including medical affairs in BD and ROW development, new and lifecycle management programs.
8. Collaborate with internal stakeholders across departments, participate in ad boards, respiratory forums, and meetings, and discuss clinical development pathways with regulators for faster approvals.
9. Develop projects and evaluate new business opportunities or internal Target Drug Candidates to expand respiratory, allergy, and inflammation pipelines, 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 development projects, 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 are essential.