Associate Director – Clinical Programme Management
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.
- 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
- 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
- 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