Senior Manager, Translational Medicine

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Senior Manager Translational Medicine

The Senior Manager, Translational Medicine will be responsible for implementing the clinical biomarker plan for assigned programs. This role will work closely with Assay Development, Clinical Operations, Clinical Development and Quality Assurance colleagues to support the development, validation, and implementation of bioanalytical methods at CRO laboratories.

The Senior Manager will be the primary point of contact for timelines, budget, sample management and data processing related to clinical biomarker analysis. The Senior Manager will represent Translational Medicine on Clinical Study sub-teams and other program meetings as needed. The Senior Manager, Translational Medicine role is based in Cambridge, MA and reports to the VP and Head of Translational Medicine.

Key Responsibilities
  • Develop and implement biomarker operational plans to support clinical programs.
  • Oversee operational activities required for generation of clinical biomarker data, including development of timelines, management of budgets, sample tracking, data transfers and data analysis.
  • Manage biomarker assay development and validation at clinical CROs, including planning and coordination with the internal central assay development group, technology transfers, and review of development/validation data from the CRO laboratory.
  • Serve as the primary point of contact for biomarker sample analysis. Address data queries and troubleshoot issues in coordination with Clinical Operations, Data Management and Quality Assurance colleagues.
  • Represent the Translational Medicine team at program sub-team meetings as needed.
  • Comply with all relevant regulatory guidelines (ICH, 21CFR Pt 11, GCP, GDPR, etc.) and internal documents (SOPs, study protocol, etc.).
Minimum Requirements/ Qualifications
  • Minimum of B.S. in relevant scientific field.
  • 5+ years of industry working experience.
  • Previous experience working on clinical stage program operations.
  • Previous experience developing and validating bioanalytical methods in the context of clinical biomarker analysis.
About AVROBIO

Our vision is to bring personalized gene therapy to the world. We aim to prevent, halt or reverse disease throughout the body with a single dose of gene therapy designed to drive durable expression of functional protein, even in hard-to-reach tissues and organs including the brain, muscle and bone. Our ex vivo lentiviral gene therapy pipeline includes clinical programs in Fabry disease, Gaucher disease type 1 and cystinosis, as well as preclinical programs in Hunter syndrome, Gaucher disease type 3 and Pompe disease. AVROBIO is powered by our industry leading plato® gene therapy platform, our foundation designed to deliver gene therapy worldwide. We are headquartered in Cambridge, Mass., with an office in Toronto, Ontario.

AVROBIO, Inc is an EEO employer