Director/ Sr Director - Clinical Development (Pulmonology)

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

Descrizione del lavoro

Join a forward-thinking organization as a Director/Sr Director in Clinical Development. This role involves leading innovative drug development projects in pulmonology, ensuring compliance with regulations while driving effective strategies for clinical studies. You will engage with global regulators, mentor teams, and contribute to the advancement of respiratory therapies. With a focus on collaboration and strategic planning, this position offers the opportunity to make a significant impact in the field of respiratory medicine while working in a dynamic and supportive environment.

Competenze

• Minimum 18 years of experience as a practicing pulmonary clinical professional.
• Over 5 years in the pharmaceutical industry or clinical projects related to drug development.

Mansioni

• Lead and mentor Clinical Sciences respiratory projects, ensuring timely milestone delivery.
• Review key study documents and provide guidance on subject eligibility and protocol-related questions.

Conoscenze

Drug Development

Scientific advocacy with policymakers/regulators

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), Pavia

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Job Reference:

194136563343425536337139

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 innovative approaches to planning clinical studies and supporting end-to-end drug development in accordance with all applicable regulations and aligning 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:

1. Lead, manage, and mentor Clinical Sciences respiratory projects, ensuring timely delivery of all milestones.
2. Contribute to and review key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
3. Review CRO medical monitoring capabilities during study startup and RFP processes, including CVs, MMPs, and investigator/site lists.
4. Provide guidance on subject eligibility, deviations, and protocol-related questions to CRO MM, site investigators, and study teams.
5. 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.
6. Attend internal or joint CRO-sponsor safety meetings and review minutes.
7. Review blinded medical coding for adverse events, prior and concomitant medications, and medical history, participating in BDRM and interpreting efficacy and safety data after unblinding.
8. Support business development for respiratory programs, including new and lifecycle management projects, and collaborate with internal stakeholders across departments.
9. Participate in ad boards, respiratory forums, and meetings, and engage with regulators on clinical development pathways for faster approvals.
10. Develop projects and evaluate new business opportunities or internal drug candidates to expand the respiratory, allergy, and inflammation pipeline, leading 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 related to drug development and regulatory interactions.

Knowledge and Skills (Functional / Technical):

• Drug Development
• Scientific advocacy with policymakers/regulators

Behavioral Attributes:

• Good decision-making and influencing skills, with strong interpersonal skills.