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Project Manager, 24-month FTC
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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 Job
Lead day-to-day operational delivery of ophthalmology clinical development programmes, managing complex clinical and CMC workstreams to ensure aligned and timely execution against programme objectives.
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 for programme delivery and issue resolution.
Serve as the primary point of contact for external partners, funders, and collaborators associated with such programme assets, ensuring clear communication, alignment of expectations, and delivery against 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.
Job Description
Key Responsibilities
- Programme Leadership: Lead end-to-end delivery of ophthalmology clinical development programmes, ensuring achievement of key milestones across scope, timelines, and budgets, with proactive management of risks, dependencies, and programme complexity.
- Cross-Functional Delivery: Direct and align cross-functional teams (pre-clinical, clinical operations, regulatory, medical writing, biostatistics, and Product Supply) to ensure integrated execution across all stages of the ophthalmology development lifecycle.
- Planning & Risk Management: Develop and maintain integrated programme plans, incorporating robust risk identification, mitigation strategies, and contingency planning to support uninterrupted programme progression.
- Regulatory & Quality Compliance: Ensure adherence to GCP, FDA and EMA requirements, and internal SOPs, embedding quality and regulatory standards across all clinical and development activities.
- Stakeholder Communication: Provide clear, data-driven updates to senior management, ensuring visibility of programme status, key deliverables, risks, and critical decision points across the ophthalmology portfolio.
- External Partner Management: Act as the primary point of contact for external partners, funders, and service providers, ensuring alignment to programme objectives, timelines, and contractual deliverables.
- Milestone & Supply Integration: Oversee critical programme milestones, ensuring alignment between Pre-Clinical, MSAT, Manufacturing, Quality, Product Supply, Regulatory and Clinical delivery to enable seamless transition to clinic.
- Governance & Reporting: Maintain accurate programme documentation and governance frameworks, supporting the preparation of high-quality reports and presentations for the Clinical and Product Supply leadership teams.
- Continuous Improvement: Identify and implement process improvements across programme and supply chain activities 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
- Bachelor’s degree in Life Sciences, or a related field, or equivalent work experience in supply chain or project/programme management within biotech or pharmaceutical industries.
- Strong understanding of clinical trial design, execution, CMC and regulatory requirements.
- Experience managing timelines, budgets, and resources in a clinical setting.
- Ability to work collaboratively in a global environment.
- PMP or equivalent certification is a plus.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), with the ability to quickly learn new systems.
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Why us?
About Us
MeiraGTx is a clinical-stage gene therapy company focused on developing potentially curative treatments for patients living with serious diseases. We currently have six programs in clinical development including three ocular indications, a salivary gland condition, and a Parkinson’s disease program. Our initial focus on diseases of the eye, salivary gland and central nervous system is based on the significant unmet medical need coupled with the high potential gene therapy has to provide meaningful clinical benefit in these areas. With headquarters in New York and London, our global footprint provides us the opportunity to partner with leading institutions around the world, allowing us to deepen our understanding of diseases and their progression.
Our team was built with deep expertise in gene therapy development, allowing us to efficiently advance our programs from preclinical to clinical development. Our core capabilities in viral vector design and optimization and gene therapy manufacturing give us a differentiated approach to developing gene therapies. Additionally, we are developing proprietary technology to potentially enable innovative gene therapy treatments whose expression can be turned on and off with an easily administered small molecule. We believe temporal control of gene therapy products has the potential to transform the gene therapy landscape.
Our state-of-the-art manufacturing facility, completed in early 2018, was designed to meet global regulatory requirements, including the current good manufacturing practices (cGMP) required by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the U.S. Food and Drug Administration (FDA). The 29,000-square foot facility has the flexibility and capacity to produce sufficient product for all our clinical trials and will scale to commercial capacity.
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