Director, Clinical Operations Excellence at Relay… · Cambridge

The Opportunity:

The Director, Clinical Operations Excellence will establish and advance scalable, fit-for-purpose operational capabilities that enable high-quality, inspection-ready clinical trial execution across Relay’s portfolio, reporting to the VP, Clinical Operations Excellence. In a lean, matrixed biotechnology environment, this role will serve as both a strategic leader and hands-on contributor, partnering with study teams, functional stakeholders, CROs, and vendors to strengthen execution, simplify processes, develop actionable operational metrics and analytics, and proactively manage operational and quality risks. As the functional lead and business process owner for Risk-Based Quality Management (RBQM), this individual will be accountable for the implementation, adoption, and continuous improvement of Relay’s RBQM framework in collaboration with relevant vendors and CROs. The role will ensure study teams apply quality risk management principles, leverage RBQM technologies, operational analytics, and data-driven oversight, and act on emerging risks in a timely and effective manner.

Your Role:

• Clinical Operations Excellence: Lead portfolio-level process improvement and operational excellence initiatives that 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.
• RBQM Leadership: Serve as Relay’s RBQM subject matter expert and business process owner, accountable for the framework, governance, adoption, and continuous improvement of RBQM practices across studies.
• Lead study teams through CtQ identification, critical data and 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.
• Systems, Metrics, and Data-Driven Oversight: Build, review, and execute operational metrics and reporting capabilities that provide clear visibility into study execution, portfolio performance, quality trends, and areas requiring action.
• Partner with study teams and functional stakeholders to interpret metrics, identify trends, support governance discussions, and translate insights into practical actions that improve execution and quality.
• Vendor Oversight and Governance: Support execution of the vendor governance strategy by organizing and facilitating governance forums, tracking decisions and actions, supporting performance oversight, issue escalation, corrective action follow-up, quality trend review, and RBQM operationalization.
• Process Excellence and Inspection Readiness: Develop and improve SOPs, work instructions, templates, playbooks, job aids, governance models, operational metrics, and inspection readiness standards.
• Champion simple, scalable, quality-focused ways of working that support audit readiness, inspection preparation, CAPA development, root cause analysis, and continuous improvement.

Your Background:

• BA/BS degree in Life Sciences, Nursing, Pharmacy, Public Health, or related discipline required; advanced degree preferred.
• 8+ years of progressive Clinical Operations experience or equivalent experience, in biotechnology, pharmaceutical, or CRO organizations, including global Phase I–III oncology or other complex clinical development programs.
• Demonstrated experience leading or implementing RBQM, operational strategy, or process improvement initiatives in a fast-paced, matrixed environment.
• 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, reviewing, and using operational metrics, dashboards, or reporting capabilities to support study execution, governance, and continuous improvement.
• Strong knowledge of GCP, ICH E6(R3), ICH E8(R1), RBQM principles, FDA, EMA, and other applicable regulatory expectations.
• Collaborative, hands-on, and comfortable operating in ambiguity, with excellent facilitation, analytical, communication, presentation, project management, and influencing skills.
• Proven ability to present complex concepts clearly and persuasively.
• Demonstrated ability to lead through influence and, where applicable, manage or mentor team members.
• Strong stakeholder management, negotiation, and influencing capabilities.

Estimated Salary Range: [$163,000 - $233,000]

The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate’s education, experience, skills and location.

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