Director, Clinical Scientist (Respiratory)
Core
Lead clinical science for late-stage (Phase 2/3) respiratory trials (asthma/COPD), driving protocol design, data analysis, and regulatory documentation.
Role type
Senior IC clinical scientist (respiratory)
Builds
Clinical trial protocols, regulatory submissions (IBs, CSRs), and study execution plans
Domain
Biopharma / Respiratory therapeutics
Required skills
Late-stage clinical trial design and execution, protocol development, regulatory documentation (IBs, CSRs), medical monitoring, site selection and initiation, cross-functional collaboration, risk management, publication strategy
Preferred skills
Small molecule and biologic modality experience, AI/ML-driven drug discovery platforms, BLA/MAA submission experience
Technologies
Clinical trial management systems, statistical analysis software, regulatory submission platforms
Responsibilities
Serve as clinical science lead for respiratory studies; Design and develop clinical trial protocols and regulatory documents; Participate in medical monitoring and data review; Support site selection and investigator engagement; Track study progress and mitigate risks; Collaborate with Clinical Operations, Regulatory, and Biostatistics teams; Ensure inspection readiness; Support publication plans and abstracts
Seniority
Director, strategic leadership with hands-on execution
