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Reporting to the Clinical Operations Lead (COL), the Clinical Trial Manager (CTM) will be responsible for the , implementation, and oversight of AVROBIO’s clinical trials. This position will ensure efficient and timely execution throughout the lifecycle of the clinical trials in compliance with SOPs, Regulatory Authorities, and ICF/GCP guidelines.
This position will be responsible for managing and archiving GXP regulated documentation through review and quality control procedures. This position creates and oversees document workflows in VEEVA, AVROBIO’s electronic document management system to ensure documents are appropriately reviewed and approved. This position designs, supports, monitors, and improves the Learning Management System. This role will also generate and maintain compliance and metrics reporting that include documentation and training KPIs.
The Associate Director, Clinical Scientist will contribute in all areas of one or multiple clinical projects including, but not limited to, study planning, protocol development, study clinical oversight, data review, interpretation and documentation. The Associate Director, Clinical Scientist will collaborate with Clinical (MD) Leads, Clinical Operations, Regulatory, Research and other functions within AVROBIO. The. Clinical Scientist will have a substantial role in protocol development, study execution, review and interpretation of scientific and clinical data and...
The PV Operations Lead manages PV activities globally across all AVROBIO products in clinical development and on the market. Specifically, the Operations lead (1) supports operational aspects of the PV system, (2) collaborates with cross-functional partners to facilitate the development of comprehensive plans, and (3) coordinates the execution of safety deliverables. The PV operations lead is also responsible for (4) project management support and coordinating achievement of PV deliverables, (5) providing input to ensure alignment...
We are looking for a Senior Research Associate who is passionate about their profession and inspired by being part of team, working in life sciences, to bring a therapy to patients. This is an opportunity to make an impact while being part of a historically significant company that is making a difference to the lives of millions of people. As a Senior Research Associate in AVROBIO’s R&D they will join the Gene Therapy & Biology...
The Senior Clinical Data Manager will execute data deliverables for all phases of clinical trials as part of the clinical development study team. This role will proactively collaborate within cross-functional AVROBIO study teams and Contract Research Organizations and other data vendors, driving end-to-end data quality and integrity from source through to submission.
The Senior Director, Global Regulatory Lead will be responsible for developing and delivering innovative global regulatory strategies for product development and approval. The individual will provide strategic direction and guidance on regulatory requirements for assigned gene therapy development programs, driving premarket strategies that lead to robust submissions and timely product approvals.
The Preclinical Laboratory, Operations, and Facilities Lead is responsible for the coordination and administration of AVROBIO’s Laboratory and internal non-GLP research activities in collaboration with AVROBIO’s researchers to support the discovery stage development programs for lentiviral-based gene therapies focusing on rare diseases, where a faulty gene results in a lack of an essential enzyme or protein. The successful candidate will work with the preclinical team by enabling AVROBIO’s Laboratory, in vitro and in vivo laboratory...
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