Associate Director, Biomarker & Assay Development

Responsibilities

• Serve as the Biomarker & Assay Development lead on cross-functional program teams
• Develop and execute biomarker and bioanalytical assay strategies to support in vivo gene editing programs from discovery through IND-enabling studies
• Design, oversee, and interpret translational and preclinical studies, including studies evaluating editing activity, target engagement, and pharmacodynamic response
• Lead assay development, vendor selection, qualification, validation, transfer, and troubleshooting with internal teams and external CROs
• Select, manage, and oversee CROs to ensure high-quality, timely delivery of study results and assay data
• Integrate biomarker and assay data into program decision-making and regulatory documentation
• Collaborate with clinical teams to coordinate management of study samples, bioanalytical analysis, and data presentation
• Manage, mentor, and develop a team of 3–4 research associates

Requirements

• PhD or equivalent experience in biology, pharmacology, molecular biology, bioengineering, or a related field
• 8+ years of relevant industry experience in biomarker development, bioanalytical assay development, translational research, or preclinical development
• Deep expertise in bioanalytical assay methods, development, qualification, and validation, ideally in support of genetic medicine, AAV, RNA, or gene editing programs
• Experience with assay platforms such as qPCR/ddPCR, ELISA/MSD, flow cytometry, NGS, or biodistribution
• Experience supporting IND-enabling studies, GLP toxicology studies, and regulatory documentation
• Prior experience with AAV or other genetic medicine delivery platforms required
• Demonstrated experience managing and mentoring research associates and/or junior scientists

About the Company

Arbor Biotechnologies is a next-generation gene editing company based in Cambridge, MA, advancing a pipeline of novel gene editing therapeutics to address a wide range of genetic conditions, from ultra-rare to common genetic diseases.