Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; Padova; Remoto; EUR 80.000 - 150.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a seasoned clinical leader to drive the development of innovative respiratory drugs. This pivotal role involves leading clinical projects, engaging with global regulators, and ensuring compliance with all regulations. The ideal candidate will have extensive experience in drug development and a strong background in pulmonary medicine, making a significant impact on the company's drug development strategies. Join a dynamic team focused on advancing healthcare solutions and shaping the future of respiratory treatments.

Competenze

• Minimum 18 years of experience as a practicing pulmonary clinician.
• Over 5 years in the pharmaceutical industry or clinical project management.

Mansioni

• Lead and manage Clinical Sciences respiratory projects.
• Review key study documents and provide guidance on subject eligibility.
• Collaborate with internal stakeholders and participate in advisory boards.

Conoscenze

Drug Development

Scientific advocacy with policymakers and regulators

Strong decision-making skills

Excellent interpersonal skills

Formazione

MD / MS

MD with specialization in Internal and Pulmonary/Critical Care Medicine

Descrizione del lavoro

Note: Incumbent can be based anywhere in Europe or the US.

Role Overview:

This position is intended to lead 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 the timely delivery of all project milestones.
• 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 startup and RFP processes, including CVs, MMP, and investigator/site lists for vendor selection.
• Provide guidance on subject eligibility, deviations, and other medical, safety, or protocol-related questions to CRO MM, 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.
• Attend internal or joint CRO-sponsor safety meetings and review minutes.
• Review blinded medical coding for adverse events, medications, and medical history, participating in BDRM prior to database lock and interpreting efficacy and safety data post-unblinding.
• Support business development for respiratory programs, including portfolio management, medical affairs, and lifecycle management.
• Collaborate with internal stakeholders such as Preclinical Research, Toxicology, DMPK, Regulatory, ClinOps, Project Management, Medical Affairs, and Legal.
• Participate in advisory boards, respiratory forums, and meetings; engage with regulators on development pathways and approvals.
• 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 with specialization in Internal and Pulmonary/Critical Care Medicine

Experience:

• Minimum 18 years of experience as a practicing pulmonary clinician, with over 5 years in the pharmaceutical industry or clinical project management, including regulatory interactions.

Knowledge and Skills:

• Drug Development
• Scientific advocacy with policymakers and regulators

Behavioral Attributes:

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