Biomarker & Assay Strategy Director – Gene Editing

Arbor

Cambridge (MA)

On-site

USD 180,000 - 230,000

Full time

14 days+

Application generator

A complete application in a minute — tailored resume and cover letter, ready to send.

Get past ATS filters

Job summary

Arbor Biotechnologies in Cambridge, MA is seeking an Associate Director, Biomarker & Assay Development to lead biomarker strategy, assay development, qualification/validation, and regulatory readiness across in vivo gene editing programs. This is an office-based leadership role with on-site presence 4–5 days per week.

You will manage a team of 3–4 research associates, oversee CROs/vendors, and collaborate with clinical teams to coordinate study samples and data.

Qualifications

PhD or equivalent in biology, pharmacology, molecular biology, bioengineering or related field.
8+ years of industry experience in biomarker development, bioanalytical assay development, translational research, or preclinical development.
Deep expertise in bioanalytical assay methods, development, qualification, and validation, ideally for genetic medicine or gene editing programs.
Experience with assay platforms such as qPCR/ddPCR, ELISA/MSD, flow cytometry, NGS, biodistribution, and related readouts.
Experience supporting IND‑enabling studies, GLP toxicology studies, and regulatory documentation.

Responsibilities

Lead biomarker strategy and assay development across in vivo programs from discovery to IND‑enabling studies.
Design, oversee, and interpret translational and preclinical studies, including target engagement and pharmacodynamic readouts.
Oversee assay development, vendor selection, qualification, validation, transfer, and troubleshooting with CROs/vendors.
Integrate data into program decisions and regulatory documentation; collaborate with clinical teams on sample management and timing.