Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Torino; In loco; EUR 90.000 - 150.000; 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 clinical studies and supporting innovative drug development while ensuring compliance with regulations. The ideal candidate will have extensive experience in pulmonary clinical practice and a strong background in the pharmaceutical industry. You will engage with global regulators and internal stakeholders, driving the strategy for respiratory programs from evaluation to registration. If you are passionate about improving patient outcomes through innovative therapies, this position offers a unique opportunity to make a significant impact.

Competenze

• Minimum 18 years of pulmonary clinical experience with over 5 years in the pharmaceutical industry.
• Experience with regulatory interactions and clinical development projects.

Mansioni

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

Conoscenze

Drug Development

Scientific advocacy with policymakers/regulators

Decision-making skills

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 for clarity and readability:

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

Client:

Location:

Job Category:

Other

EU work permit required:

Yes

Job Reference:

19413656334342553633712

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. The role involves 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:

• Lead, manage, and mentor Clinical Sciences respiratory projects, ensuring timely delivery of all deliverables.
• Contribute to and review key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
• Review CRO medical monitoring capabilities during study start-up and RFP processes, including CVs, MMP, and investigator/site lists.
• Provide guidance on subject eligibility, deviations, and other medical or protocol-related questions to CRO medical monitors, site investigators, and study teams.
• Review blinded efficacy and safety data, listings, tables, deviations, and support 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, including portfolio management and lifecycle programs.
• Collaborate with internal stakeholders across various departments and participate in ad boards, forums, and regulatory discussions.
• Drive strategy and delivery of respiratory programs from candidate evaluation to registration, including development of new business opportunities.

Knowledge and Education:

Educational Qualifications:

• MD / MS
• MD in Internal and Pulmonary/Critical Care Medicine

Experience:

• Minimum 18 years practicing pulmonary clinical experience 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.