New York, NY
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
MeiraGTx is seeking an exceptional attorney to serve as Corporate Counsel to join our growing, collegial Legal team. MeiraGTx is a NASDAQ-listed, vertically integrated, clinical stage gene therapy company with six programs in clinical development and a broad pipeline of preclinical and research programs. Our initial focus is on three distinct areas of unmet medical need: ocular, including inherited retinal diseases and large degenerative diseases, neurodegenerative diseases and severe forms of xerostomia.
The Corporate Counsel will report directly to the General Counsel and will manage a wide range of responsibilities with a strong focus on supporting the Company’s clinical trial operations.
– Support the company’s US- and Europe-based clinical trial operations teams by drafting, reviewing and negotiating a wide range of documents related to global, multi-site clinical trials.
– Draft, review and negotiate complex clinical-trial related agreements and documentation, including clinical trial agreements, non-disclosure agreements, CRO/professional services agreements, master services agreements, informed consent documents, vendor and consulting agreements, letters of indemnification, data processing/transfer agreements, supply agreements and research support agreements.
– Provide legal advice and support for company policies and procedures and operational processes related to clinical trials.
– Prepare new templates and manage revisions of current templates for use throughout the Company.
– Work on a diverse set of issues involving day-to-day transactions, including privacy (e.g., HIPAA, GDPR), regulatory matters, compliance, research and development, manufacturing, intellectual property, medicinal product import/export requirements and real estate/facilities.
– Provide high quality, timely and practical legal advice and support, identify and resolve critical legal and business issues arising from various transactions and business matters across the Company.
– Perform other tasks and assignments as needed and specified by management.
– J.D. from ABA-accredited law school, strong academic record and admission to at least one state bar.
– 3-6 years of legal experience with increasing responsibility.
– In-house experience preferred, but law firm candidates will be considered.
– Must have direct experience representing life science companies or health care institutions with clinical trial agreements; an understanding of pharmaceutical and biotech sponsored clinical trials is required. Experience working on agreements for clinical trials outside the U.S. (e.g., EU/UK) is a plus.
– Familiarity with laws, regulations and industry standards governing clinical trials, such as FDA/EMA/MHRA(UK) regulations, ICH and research ethics guidelines, clinical trial registries, GxPs (Good Clinical Practices, Good Laboratory Practices, etc.) and publications.
– Well organized, detail-oriented and accountable team player with a high degree of professionalism, diplomacy, discretion, and judgment.
– Highly motivated, self-starter and quick learner with demonstrated ability to deliver quality results within time constraints.
– Roll-up your sleeves, can-do attitude to tackle projects large and small with a service-oriented approach to collaborate across the organization.
– Demonstrated ability to work both independently and cooperatively with colleagues to leverage skills and knowledge within the organization.
– Exceptional verbal and written communication, listening and presentation skills which highlight an ability to concisely and effectively reach a diverse audience at multiple levels within the Company and through various platforms (i.e., teleconferences, face-to-face meetings, presentations, reports and correspondence).
– Excellent organizational and time management skills required to handle multiple projects simultaneously under tight timelines, prioritize and re-prioritize various duties and interact with colleagues and third parties globally.