Clinical Project Manager
We are seeking an experienced Clinical Project Manager to lead the planning, coordination, and delivery of a clinical-stage gene therapy programme, across phase II-III. Working closely with Clinical Operations, Regulatory, CMC, Quality, Biometrics, and external partners, you will ensure studies are delivered on time, within budget, and in accordance with strategic objectives.
This is a highly cross-functional role requiring strong project management skills, clinical development knowledge, and the ability to drive execution across internal teams and external vendors. You will be responsible for maintaining integrated timelines, managing risks and dependencies, coordinating key deliverables, and providing clear visibility of programme progress to senior leadership.
- Hybrid based, with 2-3 days a week in central London
Key Responsibilities
- Develop and maintain integrated clinical project plans, ensuring alignment across Clinical Operations, Regulatory, CMC, Quality, Biometrics, and external vendors.
- Lead cross-functional project meetings, track milestones, actions, risks, and dependencies, and drive accountability across stakeholders.
- Support the planning and execution of global clinical studies, ensuring study start-up, enrolment, data delivery, regulatory activities, and close-out activities remain on track.
- Partner with CROs and other service providers to oversee timelines, deliverables, performance, budgets, and issue resolution.
- Coordinate regulatory submissions, health authority interactions, and associated project plans in collaboration with Regulatory Affairs.
- Work with CMC and supply teams to ensure clinical trial materials are available to support study timelines.
- Maintain project budgets, forecasts, and resource plans, highlighting risks and proposing mitigation strategies where required.
- Prepare project reports, dashboards, and updates for leadership, ensuring key decisions, risks, and priorities are clearly communicated.
- Ensure project documentation, decisions, and study-related records are maintained in accordance with company procedures and regulatory requirements.
- Proactively identify and manage project risks, escalating issues and driving solutions to minimise impact on delivery.
Required Qualifications
- Experience in project management within biotechnology, clinical development environments.
- Experience supporting the delivery of clinical-stage development projects.
- Strong understanding of clinical operations, regulatory activities, vendor management, and study execution.
- Experience managing CROs and external service providers.
- Proven ability to manage complex timelines, budgets, risks, and multiple stakeholders simultaneously.
- Excellent communication and organisational skills with the ability to influence across cross-functional teams.
- Strong attention to detail, problem-solving ability, and a proactive, delivery-focused approach.
Preferred Qualifications
- Experience in gene therapy, ATMPs, AAV programmes, or other advanced biologics.
- Experience supporting Phase II or Phase III clinical studies.
- Knowledge of CNS development or rare disease programmes.
- Experience with global clinical trials and multi-vendor study environments.
- Degree in Life Sciences or related discipline. Project Management certification desirable.