Associate Director, Clinical Biomarker Lead

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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 development. The Clinical Biomarker Lead will manage work with CRO and/or collaborate with colleagues from Biomarker Labs to ensure fit-for-purpose validation of clinical biomarker assays prior to implementation. The Clinical Biomarker Lead serves as a key member of project teams, providing expert input to teams and guiding clinical development of novel biomarkers.

Research and Development
Aug 1 2021
Key Responsibilities
  • Build and maintain biomarker plan
  • Implement biomarker plan as part of the clinical synopsis and clinical protocol
  • Design, execution and analysis of clinical biomarkers of target engagement, safety, pharmacodynamics, and efficacy.
  • Manage outsourced biomarkers assays at external vendors
  • Coordinates between CRO assay development group and clinical team, when necessary
Minimum Requirements/ Qualifications
  • Ph.D. with 5+ years Biotechnology industry experience or Master’s degree with 10+ years Biotechnology industry experience
  • Proven track record of high-impact contributions to clinical trial biomarkers and endpoints, and regulated assay development and validation in support of early and late phase clinical trials
  • Experience with, at a minimum, enzyme activity assays, LC-MS based biomarker assays, and vector copy number (VCN) assays in a regulated setting.
  • Experience with authoring and reviewing SOPs and Validation documents in support of a regulatory filing or review.
  • Having a strong sense of urgency and excellent skills in prioritization, planning as well as timely execution in a very fast-paced environment
  • Strong interpersonal skills and ability to thrive in a matrix environment
  • Experience in managing external collaborations, contract laboratories and timelines and budgets.
  • Demonstrated scientific capability as evidenced by publications, research reports, and external presentations.
  • Effective verbal and written communication skills relating to colleagues and associates both inside and outside the corporation.
  • Flexibility to work on multiple projects as the portfolio evolves over time.

AVROBIO, Inc., a leader in lentiviral-based gene therapies, is a clinical-stage company developing disruptive therapies that have the potential to transform patients’ lives with a single dose. The Company is focused on the development of its gene therapy candidate, AVR‑RD‑01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, Cystinosis and Pompe disease. AVROBIO’s lentiviral platform has broad potential for other rare and non-rare genetic diseases. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON.

AVROBIO, Inc is an EEO employer