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
Director, Clinical Scientist (Respiratory)
Builds
Clinical-stage protein-based medicines for respiratory indications
Domain
Biopharmaceuticals / Respiratory Therapeutics
Deliverable
client delivery
Required skills
Late-stage clinical trial design and execution, Protocol development, Regulatory document authoring (IBs, CSRs), Medical monitoring, Site selection and investigator engagement, Cross-functional collaboration, Inspection readiness, Publication strategy
Preferred skills
Small molecule and biologic modality experience, AI/ML-driven drug discovery platforms, BLA/MAA submission experience
Technologies
None stated
Responsibilities
Lead clinical science for respiratory studies, Design clinical trial protocols and regulatory documents, Review and interpret clinical data for safety and compliance, Manage site selection and investigator engagement, Track study progress and mitigate risks, Support oversight committees (DSMB, Endpoint Adjudication)
Seniority
Director, strategic leadership with hands-on execution