Who are we? Arbor Biotechnologies, a clinical stage, next-generation gene editing company based in Cambridge, MA, is advancing a portfolio of first-in-class genomic medicines addressing serious diseases for which there are no existing functional cures, with a... Backed by Accel.
About the role
The Associate Director, Biomarker and Assay Development will report to the Senior Director, Translational Research, and will lead biomarker strategy, assay development, fit-for-purpose assay validation, non-clinical / clinical bioanalytical sample analysis oversight, and regulatory readiness across in vivo gene editing programs. Please note that this is primarily an office-based leadership role with close engagement with laboratory and external partner activities.
What they're looking for
- PhD or equivalent experience in biology, pharmacology, molecular biology, bioengineering, or a related fiel f
- 8+ years of relevant industry experience in biomarker development, bioanalytical assay development, translational research, or preclinical developmen t
- Deep expertise in bioanalytical assay methods, development and GxP method validation, ideally in support of genetic medicine, AAV, RNA, or gene editing programs
- Familiarity with global GCP/GLP regulations around method development, validation and conduct of non-clinical and clinical testing
- Experience with relevant assay platforms and readouts such as qPCR/ddPCR, ELISA/MSD, flow cytometry, NGS, biodistribution, editing efficiency, immunogenicity, RNA/protein biomarkers, or other molecular/cellular assays
- Experience supporting IND-enabling studies, GLP toxicology studies, and reporting in support of regulatory documentation
More about this role
The Associate Director, Biomarker and Assay Development will report to the Senior Director, Translational Research, and will lead biomarker strategy, assay development, fit-for-purpose assay validation, non-clinical / clinical bioanalytical sample analysis oversight, and regulatory readiness across in vivo gene editing programs. Please note that this is primarily an office-based leadership role with close engagement with laboratory and external partner activities. This is not a remote position, and on-site presence is required in our Cambridge office, typically 4–5 days per week.
- Serve as the Biomarker Assay Development lead on cross-functional program teams
- Develop and execute biomarker and bioanalytical assay strategies to support gene editing programs from discovery through IND-enabling studies and into clinical studies
- Design, oversee, and interpret translational and preclinical studies, including studies evaluating editing activity, target engagement and pharmacodynamic response, biodistribution, safety biomarkers, and disease-relevant endpoints
- Collaborate with internal teams to ensure bioanalytical testing strategy and vendor selection supports ongoing program...
Browse similar: Startup jobs