Clinical Programme Manager
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.
Purpose of Job
Support the planning and execution of gene therapy programmes per development plan, from initiation through to closeout. Ensure that all programme management and deliverables are completed on time and within budget and in accordance with SOPs, policies and practices. The role will highlight any risks, slippages and obstacles with plans to mitigate any issues.
- Contribute to the clinical and business project planning of MeiraGTx Gene therapy programmes.
- Support the Clinical Research & Development (R&D) projects, providing knowledge of all aspects of clinical development including supporting the day to day management of the clinical operations department.
- Collaborate with stakeholders to ensure development milestones are achieved, and issues and obstacles are managed accordingly.
- Support oversight of vendor management.
- Support the communication of timelines across the team members to ensure efficient production, scheduling and delivery of projects.
- Highlight potential risks, and actual issues with quality, budget or timelines to the senior leadership team.
- Provide oversight of project management plan development and assignments.
- Provide oversight of Quality Management components of studies. Escalate potential risks, issues, findings and corrective actions as appropriate.
- Support contract negotiations in relation to study matters.
- Report to senior leadership on team performance against project expectations.
- Facilitate continual improvements to internal processes to improve efficiency.
- Participate in internal and external audits as planned and report non-conformances and recommendations for improvement.
- Contribute to the development of the clinical quality management system through the development and review of Standard Operating Procedures and supporting documents.
- Oversee preparation of study documents, procedures, manuals and study specific training
- Support the oversight of the data transfer process at the vendor level.
- Review final programme budgets.
- Contribute to the development of key study documents such as clinical protocols, Investigator Brochures and Development Safety Update Reports.
- Support the identification of vendors required to support a study.
Key Performance Indicators
- Work with project team and senior leadership team to successfully complete clinical R&D projects to required timescales and budget.
- Deliver clinical programmes to agreed timelines
- Deliver clinical programmes to agreed budget
Key Job Competencies
- Experience of vendor management of complex projects
- Ensure regulatory compliance in terms of MHRA, FDA and EU framework
- Understand and adhere to the principles of ICH GCP and regulatory requirements in both the EU and US
- Direct reports –Clinical Trial Managers
- Financial authority for approving Purchase Orders (POs) according to clinical budget
- Educated to Degree level (or equivalent) in a Biological Science discipline.
- Proven experience of running projects in the gene therapy or advanced therapies arena.
- Significant experience of working in a translational clinical research environment.
- Proven strong project management experience.
- Ability to work unsupervised and yet have strong interpersonal skills to influence; communicate and manage change.
- Broad experience of business operations including Quality Management Systems, awareness of Expenditure and Processing of Requisitions.