Clinical Endpoints Specialist
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
Contribute to the execution of gene therapy projects by working with clinical and regulatory teams to ensure novel endpoints and assessments are appropriately validated and can be scaled up for use in multiple sites. They will partner with MeiraGTx project teams and management to effectively identify and resolve problems or concerns.
- Work closely with the clinical and regulatory teams to understand regulatory requirements for validating and implementing study endpoints
- Working with property management companies to secure potential research facilities for the duration of projects
- Ordering and arranging the shipping of supplies to sites positioned globally
- Work closely with clinical sites to manage the set up and installation of assessment devices
- Co-ordinate the manufacturing components required to up-scale assessment capability to multiple sites
- Good understanding of procurement, RFI/RFP, vendor selection, contracts, management, set up and tracking of performance.
- Ensure assessment capability is in place to coincide with study start up
- Cost management
- Ensure activities are conducted in compliance with applicable regulations and Good Clinical Practice
- Understand the technical requirements for the assessments, their mode of operation, and how that translates to clinical need
- Train staff and troubleshoot on the assessment capability
- Develop protocols to ensure reproducibility and reliability of assessments across sites
- Co-ordinate endpoint adjudication activities where required
- Compile and maintain project-specific status reports;
- Create and maintain project timelines
Key Performance Indicators
- Ensuring sites can participate fully in clinical studies with respect to their ability to assess endpoints
- Ensuring all necessary documentation and results are available to support licensing applications with respect to study endpoints
- Ensuring senior management and tracking systems for trial related paperwork remain up to date
Key Job Competencies
- Understanding of clinical trial processes and needs
- Excellent transferrable skills
- IT literacy, particularly in Word, Excel and PowerPoint
- Knowledge of ICH GCP
- Adaptable, flexible, and inventive in planning and execution of study related tasks
- Excellent communication skills
- Direct reports – none
- Financial authority for submitting clinical team expenses and raising Purchase Orders on request
- University degree or equivalent in sciences, engineering, nursing or pharmacy or related field
- Previous experience of working in Clinical Research or the Pharmaceutical Industry
- Knowledge of the Industry/Clinical trial process and drug development
- Experience of working with industry regulators (MHRA/FDA), is beneficial but not required
Experience of using the DIA Trial Master File Reference Model, is beneficial but not required