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.