Senior Clinical Program Lead

About the role

• Design and drive clinical development activities for a late-stage respiratory asset, focusing on Phase III execution, submission readiness, and pediatric development strategy • Guide cross-functional teams including clinical trial operations, biostatistics, biomarkers, and patient safety • Oversee the clinical trial program and contribute to continuous benefit-risk assessment throughout the development lifecycle • Provide input to regulatory strategy and clinical components of regulatory dossiers, labeling activities, and interactions with health authorities • Collaborate with inte…

Requirements

• • MD degree with extensive clinical and scientific experience in pulmonology or respiratory diseases
• • Several years of experience in clinical drug development within the pharmaceutical industry or equivalent experience in academic clinical research
• • Experience interacting with regulatory authorities and contributing to global regulatory submissions
• • Ability to evaluate and develop clinical development strategies, study concepts, and clinical trial designs
• • Strong leadership skills with the ability to influence and collaborate effectively across diverse stakeholder groups
• • Excellent communication skills in English, both written and verbal
• • Senior Clinical Program Lead: Long-term experience in clinical drug development within respiratory diseases
• • Senior Clinical Program Lead: Proven leadership experience in global matrix organizations and strategic project governance
• • Applications must be submitted in English

What you'll do

• • Design and drive clinical development activities for a late-stage respiratory asset, focusing on Phase III execution, submission readiness, and pediatric development strategy
• • Guide cross-functional teams including clinical trial operations, biostatistics, biomarkers, and patient safety
• • Oversee the clinical trial program and contribute to continuous benefit-risk assessment throughout the development lifecycle
• • Provide input to regulatory strategy and clinical components of regulatory dossiers, labeling activities, and interactions with health authorities
• • Collaborate with internal and external stakeholders, including development teams, key opinion leaders, steering committees, and safety monitoring boards
• • Contribute to scientific publications, evidence generation activities, and Medical Affairs deliverables
• • Senior Clinical Program Lead: Supervise and mentor other Clinical Program Leads
• • Senior Clinical Program Lead: Represent the development team in governance and leadership committees and contribute to strategic portfolio decisions

Where this was posted

• remoterocketship.com

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