Associate Director, Bioanalytical Sciences & Biomarkers

Arbor Biotechnologies•Cambridge, MA

3d•$185,000 - $200,000•Onsite

About The Position

The Associate Director, Bioanalytical Sciences & Biomarkers will lead bioanalytical and biomarker assay strategy, development, validation, and non-clinical and clinical sample analysis oversight for Arbor’s in vivo gene editing programs, from IND-enabling studies through clinical trials. Reporting to the Senior Director, Translational Research, this individual will serve as the assay lead on cross-functional program teams, partnering closely with In Vivo Pharmacology, Clinical Development, Regulatory, Quality, and external laboratory partners. The role is responsible for ensuring assay strategies are scientifically rigorous, operationally executable, and aligned with program and regulatory objectives. The core of this role is regulated assay work. You have led method development and validation for assays used in both GLP toxicology studies and clinical trials. This role leads an in-house assay team and is on-site in Cambridge 4–5 days per week.

Requirements

PhD in biology, molecular biology, bioengineering, translational science, bioanalytical sciences, or a related field.
8+ years of relevant biotech or pharmaceutical industry experience in biomarker development, bioanalytical assay development, or translational bioanalytical sciences.
Has led method development, qualification, and validation for assays used in both GLP toxicology studies and clinical trials.
Deep expertise in bioanalytical assay development, method qualification, and fit-for-purpose validation under GLP and GCLP, including support of IND-enabling and GLP toxicology studies, clinical sample analysis, and assay-related regulatory documentation.
Experience with relevant assay platforms and readouts such as qPCR/ddPCR, ELISA/MSD, flow cytometry, NGS, biodistribution assays, editing efficiency assays, immunogenicity assays, RNA/protein biomarkers, or other molecular and cellular assay technologies.
Experience managing CROs, central laboratories, specialty laboratories, or other external bioanalytical vendors.
Experience with genetic medicines or nucleic acid therapeutics, such as AAV, LNP/mRNA, oligonucleotides, or cell therapy, required; AAV and gene editing experience preferred.
Experience managing and mentoring direct reports.
Demonstrated ability to synthesize complex biomarker and assay data into clear recommendations for program teams and leadership.

Nice To Haves

AAV and gene editing experience preferred.

Responsibilities

Develop, qualify, and validate assays supporting IND-enabling, GLP toxicology, and clinical studies for in vivo gene editing programs.
Own the assays behind key endpoints, including editing activity, target engagement, pharmacodynamic response, biodistribution, vector shedding, safety biomarkers, immunogenicity (ADA/NAb), and disease-relevant biomarkers, in partnership with In Vivo Pharmacology, which owns study design.
Define assay development, qualification, validation, and sample analysis plans appropriate for non-GLP, GLP, and GCLP studies, applying ICH M10 and fit-for-purpose, context-of-use principles.
Lead vendor/CRO selection, assay transfer, method validation planning, troubleshooting, and oversight of external laboratory execution.
Oversee non-clinical and clinical bioanalytical sample analysis, including sample flow, testing cadence, assay run quality, data review, issue resolution, and timely delivery of results.
Interpret biomarker, assay, and translational data and translate findings into clear recommendations for program teams and leadership.
Author validation reports, bioanalytical study reports, and the assay sections of IND/CTA submissions.
Contribute to clinical biomarker strategy with Clinical Development.
Manage, mentor, and develop a team of 3–4 research associates and/or junior scientists.