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Salary: USD 163,000 - 233,000 / annual
Relay Therapeutics seeks a Director of Clinical Operations Excellence to establish and advance scalable, fit-for-purpose operational capabilities enabling high-quality, inspection-ready clinical trial execution across the company's portfolio. Reporting to the VP of Clinical Operations Excellence, this role combines strategic leadership with hands-on contribution in a lean, matrixed biotech environment.
Key responsibilities include leading portfolio-level process improvement and operational excellence initiatives to enhance study execution, quality, consistency, efficiency, and inspection readiness. You will serve as Relay's Risk-Based Quality Management (RBQM) subject matter expert and business process owner, accountable for framework implementation, adoption, and continuous improvement across studies. This includes guiding study teams through Critical-to-Quality (CtQ) identification, critical data and process review, risk assessments, quality controls, Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), mitigation planning, and ongoing risk review.
You will build and execute operational metrics and reporting capabilities providing visibility into study execution, portfolio performance, quality trends, and areas requiring action. Partner with study teams and functional stakeholders to interpret metrics, identify trends, and translate insights into practical improvements. Support vendor governance strategy by organizing governance forums, tracking decisions, overseeing performance, managing escalations, and operationalizing RBQM.
Develop and improve SOPs, work instructions, templates, playbooks, and inspection readiness standards. Champion scalable, quality-focused ways of working supporting audit readiness, inspection preparation, CAPA development, and continuous improvement. Partner across Clinical Operations, Clinical Development, Medical, Biometrics, Quality, Regulatory, Safety, TMF, CROs, and external providers to ensure studies are operationally feasible, risk-informed, and consistently executed.
Required: BA/BS in Life Sciences, Nursing, Pharmacy, Public Health, or related discipline; 8+ years progressive Clinical Operations experience in biotech, pharma, or CRO organizations including global Phase I–III oncology or complex clinical development programs. Demonstrated experience leading or implementing RBQM, operational strategy, or process improvement initiatives in fast-paced, matrixed environments. Strong expertise in study management, monitoring, vendor oversight, clinical trial execution, issue management, inspection readiness, and Quality Risk Management. Experience with CtQ factors, critical data and processes, KRIs, QTLs, centralized monitoring, risk mitigation, and RBQM platforms. Experience building and using operational metrics, dashboards, or reporting capabilities. Strong knowledge of GCP, ICH E6(R3), ICH E8(R1), RBQM principles, FDA, EMA, and applicable regulatory expectations. Excellent facilitation, analytical, communication, presentation, project management, and influencing skills. Proven ability to lead through influence and mentor team members.
