Director, Clinical Operations Excellence
Relay Therapeutics
August 06, 2026
Remote friendly (Cambridge, MA)
United States
Operations
Responsibilities:
- Lead portfolio-level process improvement and operational excellence initiatives to improve study execution, quality, consistency, efficiency, and inspection readiness.
- Partner with 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.
- Serve as Relay’s RBQM subject matter expert and business process owner; accountable for RBQM framework governance, adoption, and continuous improvement.
- Lead study teams through CtQ identification, critical data/process review, risk assessments, quality controls, KRIs, QTLs, mitigation planning, risk ownership, escalation pathways, and ongoing risk review.
- Integrate RBQM into protocol development, study planning, vendor oversight, monitoring strategies, data review, governance forums, issue management, and inspection readiness.
- Build and execute operational metrics and reporting for visibility into study execution, portfolio performance, quality trends, and action areas.
- Interpret metrics with stakeholders, identify trends, support governance discussions, and translate insights into improved execution and quality.
- Support vendor governance via governance forums, decision/action tracking, performance oversight, issue escalation, corrective action follow-up, quality trend review, and RBQM operationalization.
- Develop SOPs, work instructions, templates, playbooks, job aids, governance models, operational metrics, and inspection readiness standards.
- Champion simple, scalable, quality-focused ways of working to support audit readiness, inspection preparation, CAPA development, root cause analysis, and continuous improvement.
Qualifications/Skills:
- BA/BS in Life Sciences, Nursing, Pharmacy, Public Health, or related; advanced degree preferred.
- 8+ years progressive Clinical Operations experience (biotech/pharma/CRO), including global Phase I–III oncology or other complex programs.
- Demonstrated experience leading/implementing RBQM, operational strategy, or process improvement in a matrixed environment.
- Strong expertise in study management, monitoring, vendor oversight, trial execution, issue management, inspection readiness, and Quality Risk Management.
- Experience with CtQ factors, critical data/processes, KRIs, QTLs, centralized monitoring, risk mitigation, and RBQM platforms.
- Experience building/using operational metrics, dashboards, or reporting for execution, governance, and improvement.
- Strong knowledge of GCP and ICH E6(R3), ICH E8(R1), RBQM principles, FDA, EMA.
- Excellent facilitation, analytical, communication, presentation, project management, and influencing skills; comfortable operating in ambiguity.
- Proven ability to present complex concepts clearly; lead through influence and mentor as needed.
- Strong stakeholder management, negotiation, and influencing capabilities.
- Lead portfolio-level process improvement and operational excellence initiatives to improve study execution, quality, consistency, efficiency, and inspection readiness.
- Partner with 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.
- Serve as Relay’s RBQM subject matter expert and business process owner; accountable for RBQM framework governance, adoption, and continuous improvement.
- Lead study teams through CtQ identification, critical data/process review, risk assessments, quality controls, KRIs, QTLs, mitigation planning, risk ownership, escalation pathways, and ongoing risk review.
- Integrate RBQM into protocol development, study planning, vendor oversight, monitoring strategies, data review, governance forums, issue management, and inspection readiness.
- Build and execute operational metrics and reporting for visibility into study execution, portfolio performance, quality trends, and action areas.
- Interpret metrics with stakeholders, identify trends, support governance discussions, and translate insights into improved execution and quality.
- Support vendor governance via governance forums, decision/action tracking, performance oversight, issue escalation, corrective action follow-up, quality trend review, and RBQM operationalization.
- Develop SOPs, work instructions, templates, playbooks, job aids, governance models, operational metrics, and inspection readiness standards.
- Champion simple, scalable, quality-focused ways of working to support audit readiness, inspection preparation, CAPA development, root cause analysis, and continuous improvement.
Qualifications/Skills:
- BA/BS in Life Sciences, Nursing, Pharmacy, Public Health, or related; advanced degree preferred.
- 8+ years progressive Clinical Operations experience (biotech/pharma/CRO), including global Phase I–III oncology or other complex programs.
- Demonstrated experience leading/implementing RBQM, operational strategy, or process improvement in a matrixed environment.
- Strong expertise in study management, monitoring, vendor oversight, trial execution, issue management, inspection readiness, and Quality Risk Management.
- Experience with CtQ factors, critical data/processes, KRIs, QTLs, centralized monitoring, risk mitigation, and RBQM platforms.
- Experience building/using operational metrics, dashboards, or reporting for execution, governance, and improvement.
- Strong knowledge of GCP and ICH E6(R3), ICH E8(R1), RBQM principles, FDA, EMA.
- Excellent facilitation, analytical, communication, presentation, project management, and influencing skills; comfortable operating in ambiguity.
- Proven ability to present complex concepts clearly; lead through influence and mentor as needed.
- Strong stakeholder management, negotiation, and influencing capabilities.