Director of Clinical Science

Job Summary

To support the development of respiratory programs focused on asthma and COPD, the remote Director of Clinical Science will lead clinical science efforts on cross-functional study teams for Phase 2 and 3 trials, driving protocol development, data analysis, and regulatory documentation.

Key responsibilities:

• Serve as clinical science lead for respiratory studies, ensuring alignment with protocol and regulatory requirements
• Design and develop clinical trial protocols and regulatory documents in collaboration with the clinical development team
• Participate in medical monitoring activities and provide scientific support to investigators throughout the study lifecycle

Required qualifications:

• Advanced degree (PhD, PharmD, MD, MS, PMP) with 9+ years of industry experience in clinical development, specifically in late-stage respiratory studies
• Strong knowledge of clinical research methodologies, regulatory guidelines, and GCP
• Demonstrated ability to lead clinical science strategy and execution in late-stage trials
• Prior experience authoring clinical protocols, CSRs, and regulatory documents
• Excellent analytical and cross-functional collaboration skills