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.

Clinical Trial 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 studies per development plan, from initiation through to closeout. Ensure that all clinical study management and project deliverables are completed in accordance with SOPs, policies and practices.

Major Activities

  • Prepare and submit HRA application package for clinical trial approvals in the UK, and support approval application process in the US.
  • Negotiate budgets and trial agreements with sites.
  • Approve invoices within scope of agreed budget for assigned studies.
  • Accountable for site management and communication with sites
  • Accountable for site initiation activities including feasibility and the regulatory site activation process
  • Liaise with data management team and external vendors to ensure data is reported accurately and in a timely manner for the responsible studies.
  • Responsible for outsourced vendor management oversight and invoicing for responsible studies.
  • Accountable for TMF review and maintenance of clinical operations inspection readiness for studies.
  • Collaborate internally to ensure clinical milestones are achieved and to ensure issues and obstacles are managed accordingly.
  • Regularly review site and team communications, Monitoring Visit Reports and quality assurance audit findings to assess quality issues within the project. Implement corrective action plans and ensure appropriate escalation through the team.
  • Conduct co-monitoring visits.
  • Contribute to compilation and delivery of study associated documentation (protocols, IB, ICF, etc).
  • Ensure investigators and research staff training needs are met.
  • Establish and maintain good communication and relations with stakeholders in the clinical studies 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.
  • Contribute to audits and inspections as requested.
  • Accountable for set up and maintenance of Trial Master File.

Key Performance Indicators

  • Clinical trial management of MeiraGTx Gene therapy studies 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 studies.

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

Financial authority: none

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.

Associate Director – Clinical Programme Management

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

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.

Major Activities

  • Provide expert clinical operational input into project or study level documents, for example clinical development plan, clinical study protocol, clinical study reports, and may lead the delivery of study documents
  • With oversight form the Director, may lead and deliver differentiated and robust operational options for review at Investment Decision Governance interactions
  • Leads the delivery of the clinical study(s) or program(s) from concept to final CSR and through to study closed and archived to agreed budget, time, project standards, quality and scientific standards
  • Accountable for overall study or program deliverables, maintaining oversight throughout the life of the study or program by close interaction with individual study/program leaders or leadership of the study team as appropriate
  • Ensure sponsor oversight throughout the life of the study
  • Develops and manages effective risk management/mitigation plans to ensure timely delivery to quality, budget and time and escalates issues to stakeholders as appropriate
  • Responsible for planning and leading issue escalation and resolution
  • Provide input to forecasting and management of study/program delivery costs, resources and timelines
  • Contribute to the clinical and business project planning of MeiraGTx Gene therapy programmes
  • Accountable for the quality of study/program planning information into relevant planning systems.
  • Mentors and supports development of individuals within the organisation
  • Contributes to operational interactions with external entities including regulatory agencies, preferred partners/suppliers and external collaborators
  • Responsible for oversight of CROs and other clinically outsourced third party vendors for outsourced studies and programs
  • Provision to procurement clear specifications for study or program specific outsourcing
  • Devise outsourcing strategy
  • Review and operational approval of study or program specific contracts or work orders
  • Highlight potential risks, and actual issues with quality, budget or timelines to the senior leadership teams

Key Performance Indicators

  • Work with project team and senior leadership team to successfully complete clinical R&D programmes/projects to required timescale and 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

Job Responsibilities

  • Direct reports – Clinical Programme Managers, Clinical Project Managers, Clinical Trial Managers, Clinical Trial Administrators
  • Financial authority for approving Purchase Orders (POs) according to clinical budget

Job background

  • Educated to degree level (or equivalent) in a Biological Science discipline.
  • Program Management qualifications (e.g., MBA, PRINC2, PMP)
  • At least 15 years in drug development experience demonstrated in a variety of roles
  • At least 5 years of experience leading studies/programs in Clinical Development/Medical Affairs
  • 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 within the context of Clinical Drug Development
  • Extensive and proven experience in driving operational delivery, timelines, cost and quality
  • Experience and strength in working and leading matrix teams
  • Strong collaborative communication skills including the ability to engage with a diverse client base and manage through conflict
  • Excellent knowledge of ICH-GCP principles
  • Proven ability in problem solving and issues management that is solution focused
  • Experience in selection of external providers, providing clear requirements and development/review of contracts
  • Proven oversight of external providers
  • 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

Experience in a variety of academic/CRO/Sponsor organisations and countries

Clinical Programme 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

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.

Major Activities

  • 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.
  • Responsible for study or program level reporting of progress, risks, and issues
  • Provide oversight of Quality Management components of studies. Escalate potential risks, issues, findings, and corrective actions as appropriate
  • Lead the study related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance
  • 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 document
  • 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.

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

Job Responsibilities

  • Direct reports – none
  • Financial authority for approving Purchase Orders (POs) according to clinical budget

Job background

  • Educated to master’s degree level (or equivalent) in a Biological Science discipline.
  • Program Management qualifications (e.g., MBA, PRINC2, PMP)
  • At least 10 years in drug development experience demonstrated in a variety of roles
  • At least 5 years of experience leading studies/projects in Clinical Development/Medical Affairs
  • 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 within the context of Clinical Drug Development
  • Extensive and proven experience in driving operational delivery – timelines, cost and quality
  • Experience and strength in working and leading matrix teams
  • Strong collaborative communication skills including the ability to engage with a diverse client base and manage through conflict
  • Excellent knowledge of ICH-GCP principles
  • Proven ability in problem solving and issues management that is solution focused
  • Experience in selection of external providers, providing clear requirements and development/review of contracts
  • Proven oversight of external providers
  • 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
  • Experience in variety of academic/CRO/Sponsor organisations and countries

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