Executive Director, Business Process & Excellence

SUMMARY
The Executive Director, Business Process & Excellence leads CiviaONE, Civia Health’s single operating model and the enabling function that makes every team’s delivery repeatable, measured and auditable. Its purpose is to remove human variability from how Civia works: every process is embedded, continually measured and improved, so Civia delivers quality with high efficiency. A participant visit should run the same way at every Civia site, in the UK or the US. That consistency is what lets Civia scale, train to one standard and assess performance like for like, with the site operations organisation as the first priority. This is a hands-on, highly accountable role, not an advisory one: the Executive Director sets the standard, measures compliance with it and improves it, and is accountable for Civia’s compliance with CiviaONE. This leader develops, owns and implements the business process infrastructure across Civia, moves the organisation to project-based ways of working with Quality by Design at its core, and serves all teams — specifically project management, site operations and recruitment — as internal clients. The role leads the CiviaONE team and multidisciplinary teams across the UK and US.

KEY RESPONSIBILITIES

CiviaONE Operating Model & Process Infrastructure

• Set the principles, methodology and vision for CiviaONE, and lead its implementation across Civia .
• Develop, own and implement Civia’s business process infrastructure: the operating model (site and central), CiviaONE Playbook, the Study Delivery Framework and SOP/work instructions.
• Partner with Quality Assurance, which retains document control and approval within the QMS, to bring the Study Delivery Framework under version control with one owner and one change route.
• Define what is globally standard and what may vary locally between the UK and US, keeping local variation to the minimum that regulation requires, with regional roles informing global requirements.
• Ensure every process has a named owner, clear version control and a regular review cycle to improve standards at every stage.
• Maintain the CiviaONE Playbook as an audit-ready account of how Civia works, for use across the organisation, with sponsors in sales discussions and in audits.

Site Operations Standardisation

• Make the site operations organisation the first focus of CiviaONE: every site runs its core processes, from site start-up and screening to participant visits, data entry and close-down, in the same way, in the UK and the US.
• Remove human variability from site work by building the standard into roles, checklists, tools and systems, so outcomes do not depend on which person, or which site does the task. Work with training to ensure appropriate competency checks and assessments are in place
• Use the standard as the basis for scale: open new sites and onboard staff to one defined model, train to one standard and assess site and individual performance like for like.
• Measure every standard process continually and improve it through one change route, so an improvement made at one site is rolled out to all sites.
• Own compliance with CiviaONE: check adherence at every site and team and drive corrective action through to closure.

Project-Based Delivery & Quality by Design

• Lead Civia’s move to project-based ways of working, with clear governance, milestones and accountability.
• Establish the CiviaONE PMO and capacity planning, so studies, change projects and resourcing are managed from one portfolio view.
• Embed Quality by Design, in line with ICH E6(R3), so quality and risk are built into processes from the start.
• Integrate the quality management system into the operating model, partnering with Quality on system-level CAPA.

Process, Systems & Data Change

• Lead multidisciplinary teams building Civia’s process, systems and data infrastructure.
• Partner with the Clinical Systems and Data: Evidence at Scale teams and technology vendors , so that systems support processes as designed.
• Build the data process foundation for evidence at scale, including complete data capture between patient visits.
• Apply AI, including Claude, to speed up process design, documentation, training and performance analysis.

KPIs & Executive Reporting

• Build and own a network-wide KPI framework with leading and lagging indicators, comparing sites and teams like for like against the standard.
• Deliver dashboards and concise briefings for the COO, SLT and Board on process health, adoption and improvement priorities.
• Own reporting end to end — one source of truth on a regular, user-friendly cadence — so accountability for reporting sits within CiviaONE rather than with executives chasing data.
• Act on early warning signs with targeted training and mitigations before issues become deviations, findings or missed milestones.

Change Leadership & Internal Client Service

• Run CiviaONE as a service line for all teams, including delivery, sites and recruitment, understanding their needs and measuring satisfaction.
• Win teams over and lead behaviour change through influence and clear accountability, developing site-level champions to sustain standards.
• Measure adoption in practice, not just training completion, and simplify or redesign where adoption lags.

Team Leadership

• Lead, coach and develop the CiviaONE team and team members within Civia. 
• Build role-specific competency frameworks and operating-model-driven training with the Training & Compliance function.
• Grow the function as Civia scales, reallocating work flexibly to meet business priorities.

REQUIRED EDUCATION & EXPERIENCE

• Bachelor’s degree.
• Senior transformation leadership experience in a clinical research site network, SMO, CRO or comparable multi-site healthcare setting.
• Proven record of leading process, systems and data change across multiple sites, with measurable results.
• Hands-on operator who has personally run process compliance in a regulated, multi-site setting, not only advised on it.
• Track record of standardizing how work is done across a multi-site network, so performance is consistent and comparable from site to site.
• Experience establishing a PMO or project-based delivery model, and leading clinical systems and data teams (e.g. CRM, EDC).
• Strong working knowledge of ICH GCP, including ICH E6(R3), and quality management systems.
• Demonstrated ability to win teams over and influence change and to hold teams to account for adherence to agreed standards.
• Service-line mindset, treating internal teams as clients.
• Hands-on experience using AI tools (ideally Claude) to improve process, training or performance management.
• Confident and concise in presenting to executive leadership and the Board.

PREFERRED EXPERIENCE

• Formal change management certification (Prosci, APMG or equivalent).
• Lean or Six Sigma qualification.
• Advanced degree in operations, systems or change management.
• Experience implementing a single operating model across UK and US operations.
• Experience preparing for sponsor audits and regulatory inspections (MHRA, FDA) as a process owner.