Director, Clinical Scientist (Respiratory indications)
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 clinical development plans (via careerplan.io/jobs/4717291006-director-clinical-scientist-respiratory-indications-at-generatebiomedicines)
Domain
Biopharma / Respiratory therapeutics
Required skills
late-stage clinical trial design, protocol development, regulatory document authoring, medical monitoring, site management, cross-functional collaboration
Preferred skills
biologic/small molecule modality experience, AI/ML drug discovery platforms, BLA/MAA submission experience
Technologies
GCP, clinical trial management systems, statistical analysis tools
Responsibilities
Design clinical study plans, CRFs, and statistical analysis plans; review clinical data for quality and safety; manage site selection and investigator engagement; support regulatory submissions and inspection readiness; lead oversight committees (DSMB); mentor team members
Seniority
Director, strategic leadership & hands-on execution
