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.
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Clinical Operations Lead employer: Cpl UK Careers
As a Strategic Business Partner for Children and Young People within a London Borough Council, you will be part of a dynamic and supportive work environment that prioritises professional development and employee well-being. The Council fosters a culture of collaboration and innovation, offering opportunities for growth while making a meaningful impact on the community. With a focus on strong financial management and strategic planning, this role not only enhances your leadership skills but also allows you to contribute to the betterment of children's services in a vibrant urban setting.
