Advancing breakthrough therapeutics through the purposeful integration of science and engineering. Backed by Lux.
About the role
In partnership with the Director of Process Management for Clinical Research & Development, to whom this role reports, the Clinical Quality Operations Manager (CQOM) is accountable for the execution of operational quality management and inspection readiness activities across assigned clinical programs within Eikon’s clinical development portfolio. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Works with Clinical R&D peers to analyze data across Eikon’s clinical trials to identify signals and trends and translate findings into actionable process improvement strategies
- Contributes to the standardization of Clinical Quality Operations procedures, tools, and templates to ensure consistency and seamless progression throughout the study lifecycle
- Maintains current awareness of filing schedules, potential future inspections, and ongoing inspection preparation activities
- Supports CQA in developing, updating, and maintaining GCP inspection procedures and guidelines within Clinical Development Operations and Clinical R&D functional areas
- Contributes to the development and/or revision of Eikon policies, SOPs, and training materials
- Ensures the operational foundation supports favorable inspection outcomes and that study teams execute consistently against study plans and operational standards
More about this role
Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.
Position
In partnership with the Director of Process Management for Clinical Research & Development, to whom this role reports, the Clinical Quality Operations Manager (CQOM) is accountable for the execution of operational quality management and inspection readiness activities across assigned clinical programs within Eikon’s clinical development portfolio. The CQOM oversees clinical quality operations across assigned clinical programs, embedding quality-by-design (QbD) principles, risk-based quality plans, and vendor oversight into Eikon’s clinical trials. This includes ensuring consistent execution of QbD principles across assigned clinical studies,...
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