Associate Director, Biomarker & Assay Development

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. 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 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 goals.
• Lead assay development in support of GLP/GCP testing, participate in vendor selection, method transfer validation, and troubleshooting,
• OverseeGLP/GCP vendor performance 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 clinical 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 fielf
• 8+ years of relevant industry experience in biomarker development, bioanalytical assay development, translational research, or preclinical development
• 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
• Strong ability to synthesize complex biomarker and assay data into clear recommendations for program teams and leadership
• Ability to develop testing strategies in support of upcoming GLP/GCP/GCLP studies including risk assessment to define the level of method validation needed
• Strong understanding of GLP and GCP regulations for bioanalytical assays, translational biomarkers, and preclinical/clinical study packages
• Experience managing CROs/vendors and ensuring quality compliance, timely delivery, 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: 

Our values govern the work we do at Arbor, and we’re hoping that they resonate as strongly with you as they do with us! 

• 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 $165,000 - $185,000. 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.

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 CNS pipeline initially prioritizing multiple ALS targets and a co-developed, clinical program, ABO-101, for the treatment of primary hyperoxaluria type 1. The company’s unique breadth of gene editing technologies goes beyond the limitations of early editing approaches to unlock access to new gene targets and expand the therapeutic reach of genomic medicines. For more information, please visit: arbor.bio.

Who are you?

Passionate, determined, and accountable. Curious, resourceful, innovative, forward thinking, and resilient. Authentic, humble, open-minded and puts team above self. At Arbor, our people embrace these qualities, so if this sounds like you then please read on!