Spyre Therapeutics
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Healthtech • Biotech
Lead GCP Quality Assurance activities across clinical programs including audit planning and execution, managing quality issues and investigations, inspection readiness, vendor/CRO oversight, CAPA and QMS maintenance, quality metrics and continuous improvement, and cross-functional compliance support with global regulations (FDA, EMA, ICH).
Healthtech • Biotech
Physician leader responsible for strategic and operational oversight of IBD antibody clinical development. Lead the Phase 2 platform trial, drive protocol development, medical review, safety oversight, data interpretation, and regulatory interactions. Partner cross-functionally to design and execute trials, chair governance committees, mentor clinical teams, and shape registrational strategy and program-level decisions.
9 Days AgoSaved
Healthtech • Biotech
The role oversees analytical characterization and comparability studies for biologics, ensuring regulatory compliance and leadership in product development.