Associate Director, Biomarker & Assay Development

Arbor; Cambridge (MA); On-site; USD 180,000 - 230,000; Full time

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.

Skills

Biomarker development

Bioanalytical assay development

Translational research

Preclinical development

IND‑enabling studies

CRO/vendor management

Gene editing platforms

Leadership & mentoring

Regulatory readiness

Data synthesis & interpretation

Education

PhD or equivalent in biology/pharmacology/molecular biology/bioengineering or related field

Tools

qPCR/ddPCR

ELISA/MSD

Flow cytometry

NGS

Biodistribution

RNA/protein biomarkers

Job description

Associate Director, Biomarker & Assay Development

Arbor Biotechnologies™, a next-generation gene editing company based in Cambridge, MA, is advancing a pipeline of novel gene editing therapeutics to address a wide range of genetic conditions – from the ultra-rare to the most common genetic diseases. The company’s unique suite of optimized gene editors goes beyond the limitations of early editing technologies to unlock access to new gene targets and has fueled a robust pipeline of first-in-class assets focused on diseases of high unmet need. With Arbor’s lead program, ABO-101 for the treatment of primary hyperoxaluria type 1, progressing into clinical trials, the company continues to focus their research and development efforts on genomic diseases of the liver and CNS for which there are no existing functional cures. For more information, please visit: arbor.bio.

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 qualification and validation, bioanalytical sample analysis oversight, and regulatory readiness across in vivo gene editing programs. This is a primarily 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.

What You Can Expect

• 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, biodistribution, safety biomarkers, and disease‑relevant endpoints
• Lead assay development, vendor selection, qualification, validation, transfer, and troubleshooting, working closely with internal teams and external CROs/vendors
• 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 team to coordinate management of study samples, timing and cadence of bioanalytical sample analysis, QC of assay runs, data analysis and presentation of data
• Manage, mentor, and develop a team of 3–4 research associates

What You Bring

• 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 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 regulatory documentation
• Strong ability to synthesize complex biomarker and assay data into clear recommendations for program teams and leadership
• Strong understanding of regulatory expectations for bioanalytical assays, translational biomarkers, and preclinical study packages
• Experience managing CROs/vendors and ensuring quality, timelines, and scientific rigor
• Prior experience with AAV or other genetic medicine delivery platforms required; gene editing experience strongly preferred
• Demonstrated experience managing and mentoring research associates and/or junior scientists
• Ability to work independently and collaboratively in a fast‑paced, matrixed team environment
• Excellent planning, organization, communication, and interpersonal skills

Our Values

• Purposeful Action: Driven by outcomes, guided by purpose
• Bold Resilience: Speak boldly, embrace change, grow forward
• Humble Authenticity: Be real, value the uniqueness of others, elevate all

The anticipated salary range for candidates for this role will be $XX - $XX. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, industry knowledge, technical skills, and other factors that may prove relevant during the interview process.

We promote diversity and inclusion not just in our recruitment processes, but in everything we do. We’re an equal opportunity employer and we will continue to ensure our recruitment process is free of bias and our workplace is inclusive, positive, and free of discrimination and respecting of all backgrounds and beliefs.