Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Genova; In loco; 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. This pivotal role involves leading innovative drug development strategies and ensuring compliance with regulatory standards. The successful candidate will manage clinical projects, engage with global regulators, and mentor teams, driving the advancement of respiratory therapies. With a focus on collaboration and strategic planning, this position offers a unique opportunity to influence the future of pulmonary medicine. If you are a seasoned professional with a passion for clinical excellence and innovation, this role is designed for you.

Competenze

• 18 years as a practicing pulmonary clinical professional.
• 5 years in the pharmaceutical industry with regulatory interactions.

Mansioni

• Lead and mentor Clinical Sciences respiratory projects.
• Review key study documents and CRO medical monitoring capabilities.
• Collaborate with stakeholders and engage with regulators.

Conoscenze

Drug Development

Scientific advocacy

Decision-making

Interpersonal skills

Formazione

MD / MS

MD in Internal and Pulmonary/Critical Care Medicine

Descrizione del lavoro

Social network you want to login/join with:

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

col-narrow-left

Client:

Location:

Job Category:

Other

-

EU work permit required:

Yes

col-narrow-right

Job Reference:

19413656334342553633717

Job Views:

2

Posted:

08.05.2025

col-wide

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 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 to facilitate 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 to ensure 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 start-up and RFP processes, including CVs, MMP, and investigator/site lists.
4. Provide guidance on subject eligibility, deviations, and other medical or safety 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 subject safety or study integrity.
6. Attend internal or joint CRO-sponsor safety meetings and review meeting minutes.
7. Review blinded medical coding and participate in BDRM prior to database lock, providing primary interpretation post-unblinding.
8. Support business development for respiratory programs, portfolio, and medical affairs in BD and ROW development, including lifecycle management.
9. Collaborate with internal stakeholders and participate in ad boards, forums, and presentations. Engage with regulators on development pathways and approval processes.
10. Develop projects and evaluate new business opportunities or internal drug candidates to expand the respiratory, allergy, and inflammation pipeline, 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 as a practicing pulmonary clinical professional with over 5 years in the pharmaceutical industry or clinical projects, including regulatory interactions for drug development.

Knowledge and Skills (Functional / Technical):

• Drug Development
• Scientific advocacy with policymakers/regulators

Behavioral Attributes:

• Strong decision-making and influencing skills.
• Good interpersonal skills.