Gene Therapy Clinical Operations Lead

Cpl Group; Greater London; On-site; GBP 90,000 - 120,000; Full time

Job summary

CPL Group is seeking an experienced Clinical Operations Lead to join a fast-moving biotech focused on gene therapy programmes in neurological and psychiatric diseases. This hands-on leadership role drives late-stage delivery and evidence generation to support regulatory readiness.

You will oversee Phase II/III multi-country trials, manage CROs and budgets, and implement a QMS with a focus on ICH-GCP compliance.

Qualifications

• 10+ years of clinical operations leadership or programme leadership in biotech/pharma/CRO
• Proven track record leading Phase II/III or pivotal multi-country trials
• Strong experience in managing CROs, vendors, budgets, timelines, quality, and risk
• Solid knowledge of ICH-GCP and clinical trial regulations, patient safety, and data integrity
• Experience establishing a QMS and supporting protocol design
• Entrepreneurial, hands-on mindset in a lean, fast-evolving environment

Responsibilities

• Lead the operational planning, setup and execution of Phase II/III and pivotal trials across countries.
• Establish and support QMS development, protocols and regulatory submissions.
• Oversee CROs, vendors and study teams to manage quality, timelines, budgets and risk.
• Drive investigator and site engagement, patient recruitment, data quality, safety surveillance and inspection readiness.
• Identify and implement AI and digital solutions to improve trial execution, enrolment and monitoring.
• Support evidence generation for registration, reimbursement and future commercial launch.
• Build clear internal reporting and dashboards to provide visibility of progress, risks and priorities.

Skills

Clinical operations leadership

Phase II/III trials

CRO management

ICH-GCP

QMS development

Data integrity

Tools

EDC systems

Regulatory submissions

Job description

CPL Group is seeking an experienced Clinical Operations Lead to join a fast-moving biotech focused on gene therapy programmes in neurological and psychiatric diseases. This hands-on leadership role drives late-stage delivery and evidence generation to support regulatory readiness.

You will oversee Phase II/III multi-country trials, manage CROs and budgets, and implement a QMS with a focus on ICH-GCP compliance.