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Job
Openings

Director, CMC Analytical Validation

The Director, CMC Analytical Validation is responsible for method transfers; method improvement; method remediation and method validation/verification and/or troubleshooting for late stage clinical products within the Quality Control laboratories. S/he manages both external CMOs and CROs in the cell and gene therapy space, including but not limited to, Drug Product (DP) release testing and characterization. In cooperation CMOs and CROs, S/he is responsible for planning, reviewing and approving analytical method qualifications and validation preBLA at all CMOs and CROs. S/he will be highly

Manufacturing
Cambridge

Director, Clinical Quality & Compliance Lead

The Director, Clinical Quality & Compliance Lead will serve as the business and process strategic leader responsible for planning, optimizing, implementing, managing, and continuously improving the following within the Clinical organization: Standard Operating Procedures (SOPs), systems, processes, communication, and infrastructure (internal and external) in support of AVROBIO clinical programs. This role will partner with the Clinical functions, Quality Assurance, Supply Chain, and other departments within AVROBIO as well as investigational sites and clinical vendors.

Research and Development
Cambridge

Associate Director, Clinical Biomarker Lead

The Clinical Biomarker Lead will be responsible for implementing the clinical biomarker strategy and execution for assigned program(s) Clinical Trial(s) and implementing the biomarker plan during clinical development.

The Clinical Biomarker Lead will collaborate with Research/Preclinical and Clinical Development on development of translational biomarker plans and inclusion of Clinical Biomarkers in clinical studies, including study design. The role will coordinate with Translational Data Sciences and Advanced Analytics to support quantitative pharmacological approaches during clinical

Research and Development
Cambridge

Head of Clinical Data Management

As a senior role within Clinical Development Operations, the Head of Clinical Data Management, will be accountable for the delivery, integrity, and quality of the clinical data across AVROBIO’s portfolio. S/He will be responsible for building a high-functioning data management team and serve as the in-house data management expert. S/He will develop a clear operational roadmap for the Clinical Development Management function, including but not limited to developing data standards (CDISC programming, TFLs, SDTM, and ADaM datasets), eCRF libraries, and standard procedures to support data

Research and Development
Cambridge

Program Leader

AVROBIO is seeking a highly capable Program Leader who is passionate about drug development and inspired by the prospect of joining a company whose vision is to bring personalized gene therapy to the world.

We are looking for a motivated professional with strong leadership and program management skills to drive the advancement of gene therapy programs in AVROBIO’s pipeline. The Program Leader will work collaboratively to develop overall strategy and operational plans, and to orchestrate key activities of diverse functions (research, preclinical, clinical/medical, manufacturing, operations

Program Management
Cambridge

Pharmacometrician/Quantitative Pharmacologist

We are looking for a Pharmacometrician/Quantitative Pharmacologist who is passionate about their profession and inspired by being part of a team, working in life sciences, to bring Lentiviral Gene Therapy to patients.

As a Pharmacometrician/Quantitative Pharmacologist for Lentiviral Gene Therapy, you will support the development of these novel therapeutic modalities from early phase to late phase and regulatory submissions. This individual demonstrates significant knowledge of pharmacometrics/quantitative pharmacology and will be responsible to apply novel translational PK/PD and PBPK

Research and Development
Cambridge

Head of Clinical Data Management

As a senior role within Clinical Development Operations, the Head of Clinical Data Management, will be accountable for the delivery, integrity, and quality of the clinical data across AVROBIO’s portfolio. S/He will be responsible for building a high-functioning data management team and serve as the in-house data management expert. S/He will develop a clear operational roadmap for the Clinical Development Management function, including but not limited to developing data standards (CDISC programming, TFLs, SDTM, and ADaM datasets), eCRF libraries, and standard procedures to support data

Research and Development
Cambridge

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