Clinical Quality Operations Manager

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.

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, facilitating identification of Critical to Quality (CtQ) factors and associated risk assessments, and establishing and actively maintaining study-specific quality plans throughout the study lifecycle using a risk-based approach. The CQOM is accountable for maintaining inspection readiness through disciplined execution of risk assessments, quality plans, and operational standards, in collaboration with Clinical Quality Assurance (CQA) on inspection preparation, management and follow-up activities.

The successful candidate will work closely with cross-functional Clinical Research & Development teams to ensure successful completion of studies within timelines and budget, with a focus on exquisite quality to support operational excellence and world-class in-house clinical study management.

This role requires onsite presence at minimum 3 days per week in our Millbrae, CA or Jersey City, NJ offices to support effective management, operational excellence, and high-performance delivery of clinical studies and expected team growth & collaboration.

You are a collaborative, hands-on quality operations professional who enjoys working alongside clinical study teams to strengthen consistency, embed quality and drive disciplined trial execution. You bring credibility through deep knowledge of GCP and strong clinical operations expertise and are energized by cross-functional partnership. You are excited about the opportunity to help shape a new function in a growing organization.

• Ensures consistent execution of ‘quality by design’ principles in assigned clinical trials. Reviews Risk Assessment and Categorization Tools (RACTs), quality plans, and study-specific procedures with Study Management Teams to confirm accuracy, compliance with Sponsor requirements, and inspection-readiness.
• Facilitates review of CtQs, quality plans and risk mitigation approaches to identify inconsistencies, emerging signals, and trends and to provide relevant feedback to the Head of Clinical Study Management and Director of Process Management for Clinical R&D, as appropriate.
• 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.
• In partnership with the Director of Process Management for Clinical R&D, the Head of Clinical Data Analytics and Reporting and the Head of Clinical Study Management, builds proficiency in leveraging technology and data to recognize and respond to new and emerging risks across assigned…