Clinical Operations Lead

Cpl Group; Greater London; On-site; GBP 90,000 - 130,000; Full time

Job summary

CPL Group in the UK seeks an experienced Clinical Operations Lead to drive late‑stage gene therapy programmes in neuroscience. You will lead multi‑country trials, ensure delivery against timelines and budgets, and align operations with regulatory and commercial readiness.

You will oversee CROs, vendors and study teams, establish QMS, uphold data integrity and safety, and build transparent dashboards for programme risk and progress.

Qualifications

• 10+ years’ experience in clinical operations or leadership.
• Proven track record in Phase II/III or pivotal multi-country trials.
• Strong CRO/vendor management and budget oversight.

Responsibilities

• Lead Phase II/III multi-country trials and site selection.
• Oversee CROs, vendors, budgets, and timelines.
• Drive data quality, safety surveillance and inspection readiness.
• Develop dashboards to track progress and risks.

Skills

Clinical Operations

Trial Leadership

CRO Management

Budget Oversight

QMS Development

Regulatory Compliance

Data Integrity

Digital Trials

Job description

Clinical Operations Lead – Gene Therapy

An exciting opportunity for an experienced Clinical Operations leader to join a fast-moving, entrepreneurial biotech developing innovative gene therapy programmes in neurological and psychiatric diseases. This highly empowered, hands-on position will lead late-stage clinical delivery, combining operational rigour with a forward-looking approach to technology, evidence generation and commercial readiness.

Key responsibilities:

• Lead the operational planning, set-up and execution of Phase II/III and pivotal clinical trials, including country, site and vendor selection.
• Establish and support QMS development, protocols and regulatory submissions.
• Oversee CROs, vendors and study teams, ensuring quality, timelines, budgets and operational risks are effectively managed.
• Drive investigator and site engagement, patient recruitment, data quality, safety surveillance and inspection readiness.
• Identify and implement pragmatic AI and digital solutions to improve trial execution, enrolment and safety monitoring.
• Support evidence generation for registration, reimbursement, payer discussions and future commercial launch.
• Build clear internal reporting and dashboards to provide visibility of programme progress, risks and priorities.

Experience required:

• 10+ years’ experience in clinical operations, clinical development operations or clinical programme leadership within biotech, pharma or CRO environments.
• Demonstrated leadership of Phase II/III or pivotal multi-country/global trials.
• Strong experience managing CROs, vendors, budgets, timelines, quality and risk.
• Sound knowledge of ICH-GCP, clinical trial regulations, patient safety and data integrity.
• Experience establishing a QMS and supporting clinical protocol design.
• A hands-on, entrepreneurial mindset and confidence working in a lean, rapidly evolving environment.

Gene therapy, CNS/neuropsychiatry, registration-enabling Phase III programmes and AI/digital clinical-trial technology experience would be highly advantageous.