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Reporting to the Head of Clinical Operations the Clinical Operations Lead will provide operational leadership and expertise in the implementation of clinical development programs. In conjunction with the cross-functional project team, the Clinical Operations Lead is responsible for overseeing the coordination, management and operational aspects of Clinical Programs to ensure successful completion of projects and ensure delivery of company goals on time, within budget, and in compliance with SOPs, Regulatory Authorities and ICH/GCP guidelines.
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 readiness, resource management, writing laboratory procedure
This position manages activities to support the preclinical 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 development team by supporting: preclinical study execution, request for quotation (RFQ) and program costs negotiation, laboratory selection and qualification, study protocol design and review, study monitoring, data and report review, and integrated nonclinical analytical and bioanalytical support, program and