Director/Senior Director Site Excellence

Care Access

21d•Remote

About The Position

The Director/Senior Director Site Excellence is a senior leadership role accountable for the strategy, design, build-out, and delivery of operating models supporting specialized, non-traditional, and partner-operated clinical research sites across the United States. This role is intentionally designed for a leader who can operate at both altitude and ground level—setting strategy, defining governance, and building scalable frameworks, while also remaining deeply hands-on in execution, problem-solving, and site engagement. The portfolio requires differentiated management outside the traditional site network due to its unique operational, regulatory, and partnership nuances. The role demands a leader who can build processes, translate site-level realities into enterprise processes, and personally drive outcomes during periods of growth, complexity, and change.

Requirements

Demonstrated success building and scaling non-traditional, partner-led, or complex site operating models.
Proven ability to operate as both strategist and hands-on operator in high-growth or ambiguous environments.
Deep understanding of site-level execution: startup, enrolment, regulatory processes, sponsor engagement, and remediation.
Strong working knowledge of FDA regulations, GCP, and clinical trial operations.
P&L ownership experience across multi-site portfolios.
Exceptional executive communication, influence, and change-management skills.
Bachelor’s degree required; advanced degree (MBA, MPH, MS, or similar) strongly preferred.
12–15+ years of progressive leadership experience in clinical research operations, site management, or healthcare services.

Nice To Haves

Experience standing up sites or operational excellence functions.
Background in decentralized or innovative clinical trial delivery models.
Experience operating in matrixed, global organizations.

Responsibilities

Strategic Leadership & Portfolio Oversight
Own the end-to-end strategy, operating model, and performance of US-based specialized and franchise clinical research sites.
Identify opportunities to scale, optimize, or replicate successful site and franchise models.
Hands-On Execution & Delivery
Serve as the primary owner for building and operationalizing processes across site startup, enrolment, performance management, quality oversight, and partner engagement.
Engage directly with sites and partners to assess operations, diagnose issues, and drive rapid resolution.
Lead critical initiatives personally until they are stable, scalable, and ready for delegation.
Act as the senior escalation point for complex operational, regulatory, and partner challenges.
Operational Excellence & Scalability
Oversee site startup, onboarding, and integration for new specialty site models.
Build and embed operational excellence frameworks informed by best practices from high-performing sites.
Establish KPIs, dashboards, and review cadences to monitor performance across quality, enrolment, timelines, cost, and patient experience.
Drive continuous improvement initiatives to enhance efficiency, scalability, and operational resilience.
Partner & Stakeholder Leadership
Serve as the executive owner for partner site relationships, ensuring alignment with quality standards, brand expectations, and contractual obligations.
Lead senior-level engagement with sponsors, CROs, and internal stakeholders tied to partner and specialized sites.
Translate protocol, sponsor, and regulatory requirements into practical, scalable guidance for site execution.
Quality, Compliance & Risk Ownership
Ensure all sites operate in compliance with GCP, FDA regulations, IRB requirements, and applicable state and federal laws.
Partner with Quality, Compliance, and Legal teams to proactively identify and mitigate operational and regulatory risks.
Oversee audit readiness, inspection outcomes, and corrective/preventive action plans across the portfolio.
Financial & Business Accountability
Own P&L performance for specialized and partner site operations.
Partner with Finance to build budgets, forecasts etc.
Identify opportunities for sustainable growth, margin improvement, and cost optimization.
Team Leadership & Capability Building
Build and lead a high-performing leadership team responsible for site operations and operational excellence.
Establish role clarity, decision rights, and performance expectations across the organization.
Coach leaders to move from reactive site support to proactive, scalable execution.
Maintain personal ownership of critical workstreams while building long-term organizational capability.