Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Cremona; In loco; EUR 100.000 - 160.000; 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 the clinical development of new drugs, planning studies, and ensuring compliance with regulations. You will engage with global regulators, manage clinical projects, and support business development initiatives. Ideal candidates will possess extensive experience in pulmonary medicine and drug development, showcasing strong decision-making and interpersonal skills. Join a dynamic team dedicated to advancing respiratory therapies and making a significant impact in the field.

Competenze

• 18+ years in pulmonary clinical practice, with over 5 years in pharma.
• Experience with regulatory interactions for drug approval.

Mansioni

• Lead and mentor Clinical Sciences respiratory projects.
• Review key study documents and CRO medical monitoring capabilities.
• Collaborate with stakeholders on clinical development pathways.

Conoscenze

Drug Development

Scientific advocacy with policymakers/regulators

Decision-making and influencing skills

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), Cremona

Client:

Location:

Job Category: Other

-

EU work permit required: Yes

Job Reference: 194136563343425536337134

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, including planning clinical studies and supporting end-to-end drug development in accordance with all applicable regulations and aligning with the company's business objectives. This includes discussions with global regulators on respiratory clinical development pathways for facilitating drug approvals; review & due diligence of in-licensing respiratory molecules; presentations in ad boards and global respiratory meetings.

Job Responsibilities:

1. Lead, manage, and mentor Clinical Sciences respiratory projects ensuring timely delivery of all deliverables.
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 for vendor selection.
4. Provide guidance on subject eligibility, deviations, and other medical, safety, or 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 blinded SAE or SUSAR documents, addressing or escalating data impacting safety or study integrity.
6. Attend internal or joint CRO-sponsor medical monitoring safety meetings and review minutes.
7. Review blinded medical coding for AEs, SAEs, medications, and medical history; participate in BDRM and interpret efficacy and safety data post-unblinding.
8. Support business development for respiratory programs, portfolio, med affairs, and lifecycle management programs.
9. Collaborate with internal stakeholders across departments, participate in ad boards, forums, and regulatory discussions on clinical development pathways.
10. Develop projects and evaluate new business opportunities for respiratory, allergy, and inflammation pipeline expansion, leading 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 practicing pulmonary clinical professional experience with >5 years in the pharmaceutical industry or clinical projects in drug development; regulatory interactions for drug approval.

Knowledge and Skills (Functional / Technical):

• Drug Development
• Scientific advocacy with policymakers/regulators

Behavioral Attributes:

• Decision-making and influencing skills; good interpersonal skills.