Clinical Endpoints Specialist

About MeiraGTx

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.

Major Activities

  • 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

 Job Responsibilities

  • Direct reports – none
  • Financial authority for submitting clinical team expenses and raising Purchase Orders on request

Job background

  • 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

Clinical Project Manager

About MeiraGTx

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 per development plan, from initiation through to closeout. Ensure that all clinical study management and project deliverables are completed on time and within budget and in accordance with SOPs, policies and practices.

Major Activities

  • The CPM is accountable for leading with success the execution of data generation activities for projects assigned by the Associate Director – Clinical Programme Management or Director Clinical Operations
  • The CPM serves as the single point of end-to-end accountability for assigned projects, leading the Study Management Team for global, regional or complex studies, interfacing with the Clinical Teams, functional representatives, stakeholders or other internal/external sponsors, external service providers e.g., contract research organisations (CRO)
  • Primary accountability at the trial level. This includes all project activities staring from protocol development to delivery of the final Clinical Study report (CSR) or other deliverable(s), according to planned milestones, within budget, and with high quality standards per company procedures and regulatory requirements
  • CPM provides operational leadership to the execution plan and defines risk mitigation strategies and ensures implementation thereof. Co-ordinates activities in the Trial Team and ensuring ad-hoc trial Working Groups are organized as needed, driving issue identification and resolution, contingency planning and decision making
  • Support project team members to be compliant with current ethical and regulatory guidelines and requirements
  • Support budget negotiation and trial agreements with sites
  • Oversee program budget and provide input
  • Develop project management plan and be responsible for cross functional project meetings
  • Liaise with data management team and external vendors to ensure data is reported accurately and in a timely manner for the responsible program
  • Responsible for outsourced vendor management oversight and invoicing
  • Responsible for the communication of timelines across the team members to ensure efficient production, scheduling and delivery of project
  • Accountable for oversight of TMF review and maintenance and for clinical operations inspection readiness
  • Collaborate internally and externally to ensure clinical milestones are achieved and to ensure issues and obstacles are managed accordingly
  • Tracks project progress against timelines. Monitors patient recruitment rate to ensure that target enrollment will be met across the allocated region/countries
  • Provide regular status updates to Clinical Trial Team and Management. Ensures required reports are generated and available for real time tracking of project status
  • Mitigate clinical risk by problem solving and contingency plan development
  • Oversee site and team communications and compliance with regulations and SOPs
  • Oversee and support quality assurance
  • Supervise the implementation of corrective action plans
  • Oversee activities outsourced to CRO
  • Identify and contribute to compilation and delivery of study associated documentation (protocols, IB, ICF, etc.)
  • Review trial data and procedures ensuring good quality data
  • Establish and maintain good communication and relations with stakeholders in the clinical programmes including investigators, CROs, and regulatory consultants
  • Contribute to the development of the clinical quality management system through the development and review of Standard Operating Procedures and supporting documents.
  • Provide assistance and participate in audits and inspections

Key Performance Indicators

  • Clinical trial management of MeiraGTx Gene therapy programmes using industry standard project management tools and training materials and compliance with Good Clinical Practice, standard processes and procedures.
  • Implement continuous improvement activities for gene therapy programmes.
  • Co-ordinate outsourced vendor agreements and costings

Key Job Competencies

  • 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.

Job Responsibilities

  • Direct Reports: none
  • No financial authority

Job background

  • Educated to Degree level (or equivalent) in a Biological Science discipline.
  • 5+ years of clinical trial management experience to include trials of an advanced medicinal product.
  • 2+ years of clinical trial management experience in a commercial setting.