Director/ Sr Director - Clinical Development (Pulmonology)

JR Italy; L'Aquila; Remoto; EUR 80.000 - 150.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a visionary leader to drive the clinical development of innovative respiratory drugs. This role involves strategic oversight of clinical studies, collaboration with global regulators, and mentoring project teams to ensure compliance with regulations and business objectives. You will play a pivotal role in shaping the future of drug development, engaging with stakeholders, and expanding the pipeline for respiratory and allergy treatments. If you are passionate about making a significant impact in the pharmaceutical field, this opportunity is perfect for you.

Competenze

• 18 years of experience as a pulmonary clinical professional.
• Over 5 years in pharmaceutical industry or clinical development.

Mansioni

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

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

Job Description:

Note: The 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 planning clinical studies and supporting 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 presentations at 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 process, including CVs, MMPs, and investigator/site lists for vendor selection.
• Provide guidance on subject eligibility, deviations, and 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 meeting 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 and portfolio, including medical affairs and lifecycle management.
• Collaborate closely with internal stakeholders across various departments and participate in ad boards, respiratory forums, and meetings.
• Engage with regulators on clinical development pathways and approval processes.
• Develop projects and evaluate new business opportunities or internal drug candidates to expand the respiratory, allergy, and inflammation pipeline, driving 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 of experience as a practicing pulmonary clinical professional, with over 5 years in the pharmaceutical industry or clinical projects involving clinical development and 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.