Clinical Operations Lead

About the Position

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 programs in neurological and psychiatric diseases. This highly empowered, hands-on position will lead late-stage clinical delivery, combining operational rigor with a forward-looking approach to technology, evidence generation, and commercial readiness.

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 Quality Management System (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, enrollment, 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 program progress, risks, and priorities.

Requirements

• 10+ years’ experience in clinical operations, clinical development operations, or clinical program 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.

Nice to Have

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

We Offer

• Competitive salary: £120,000 - £140,000 per annum
• Location: London, United Kingdom
• Employment Type: FULL_TIME

About the Company

Cpl is an equal opportunities employer and welcomes applicants from all backgrounds. We are committed to creating an inclusive environment for all employees.

For further details, please apply directly or contact Rebekah Russel.