MeiraGTx
Project Manager, 24-month FTC
Greater London
Posted 11 days ago
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MeiraGTx_ Ophthalmology Clinical Development Programme Lead
Summary
Lead and oversee the end-to-end planning and execution of MeiraGTx’s ophthalmology clinical development programmes, ensuring alignment across all stages. Provide regular, clear updates to senior management on pre-clinical & clinical progress, development activities, operational delivery, and regulatory milestones and timelines.
Purpose of the Job
- Lead day-to-day operational delivery of ophthalmology clinical development programmes, managing complex clinical and CMC workstreams to ensure aligned and timely execution.
- Drive end-to-end planning and cross-functional coordination across clinical, development, operational, and regulatory activities, leading project teams and acting as the central point of accountability.
- Serve as the primary point of contact for external partners, funders, and collaborators, ensuring clear communication and adherence to agreed milestones.
- Deliver consistent, high-quality communication to senior management on programme status, key deliverables, risks, and timelines across all stages of the ophthalmology development lifecycle.
Key Responsibilities
Programme Leadership
- Lead end-to-end delivery of ophthalmology clinical development programmes, ensuring key milestones are met within scope, timelines, and budgets.
- Proactively manage risks, dependencies, and programme complexity.
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Cross-Functional Delivery
- Direct and align cross-functional teams (pre-clinical, clinical operations, regulatory, medical writing, biostatistics, and Product Supply) for integrated execution.
Planning & Risk Management
- Develop and maintain integrated programme plans with robust risk identification, mitigation strategies, and contingency planning.
Regulatory & Quality Compliance
- Ensure adherence to GCP, FDA, and EMA requirements, and internal SOPs; embed quality and regulatory standards.
Stakeholder Communication
- Provide clear, data-driven updates to senior management on programme status, deliverables, risks, and critical decision points across the ophthalmology portfolio.
External Partner Management
- Act as the primary external contact (funders, collaborators, service providers) to align expectations and ensure milestone delivery.
Milestone & Supply Integration
- Oversee alignment between Pre-Clinical, MSAT, Manufacturing, Quality, Product Supply, Regulatory, and Clinical delivery for seamless clinic transitions.
Governance & Reporting
- Maintain accurate programme documentation and governance frameworks. Support high-quality reports/presentations for Clinical and Product Supply leadership teams.
Continuous Improvement
- Identify and implement process improvements to enhance operational efficiency, scalability, and delivery performance.
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Key Job Competencies
- Project & Programme Leadership
- Cross-Functional Leadership
- Strategic Planning & Execution
- Stakeholder Communication & Influencing
- Risk Management & Problem Solving
- Regulatory & Quality Compliance
- Clinical Supply & Delivery
- External Partner Management
Qualifications
Education & Experience
- Bachelor’s degree in Life Sciences (or a related field), or equivalent experience in:
- Supply chain project/programme management within biotech/pharma
- Strong understanding of:
- Clinical trial design
- CMC and regulatory requirements
- Timeline, budget, and resource management in clinical settings
- Ability to collaborate globally
- PMP certification (or equivalent) is a plus
Technical Skills
- Proficiency in Microsoft Office Suite (Word/Excel/PowerPoint) and ability to learn new systems quickly
Why MeiraGTx?
About Us
- Clinical-stage gene therapy company developing treatments for diseases with serious unmet medical needs (ocular, salivary gland, CNS).
- Headquartered in New York and London; projects with global partners.
- Innovative approaches: on/off switchable gene therapy, scalable manufacturing to meet cGMP and regulatory standards (Type: FDA, EMA).
- Advanced 29,000 sq. ft. manufacturing facility supporting full clinical trial to commercial scaling.
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Skills
Project Management
Programme Leadership
Cross-Functional Leadership
Strategic Planning
Stakeholder Communication
Risk Management
Regulatory Compliance
Clinical Supply Delivery
External Partner Management
Clinical Trial Design
CMC
Budget Management
GCP
FDA Requirements
EMA Requirements
Microsoft Office Suite