Associate Director Bioanalytical Sciences & Biomarkers

Arbor Biotechnologies; Cambridge (MA); Vor Ort; USD 185.000 - 200.000; Vollzeit

Zusammenfassung

Arbor Biotechnologies is seeking an Associate Director, Bioanalytical Sciences & Biomarkers to lead assay strategy, development, validation, and non-clinical and clinical sample analysis for in vivo gene editing programs from IND-enabling studies through clinical trials.

Reporting to the Senior Director, Translational Research, you will serve as the assay lead on cross-functional program teams, oversee a 3-4 member in-house team, and ensure assays are rigorous, compliant (GLP/GCLP), and deliver

Qualifikationen

• PhD in biology, molecular biology, bioengineering, translational science, bioanalytical sciences, or related field.
• 8+ years of relevant biotech/pharmaceutical industry experience in biomarker development or biomarker assays.
• Led method development, qualification, and validation for assays used in GLP toxicology studies and clinical trials.

Aufgaben

• Develop, qualify, and validate assays for IND-enabling, GLP toxicology, and clinical studies for in vivo gene editing programs.
• Own assays behind endpoints such as editing activity, target engagement, PD response, biodistribution, vector shedding, safety biomarkers, immunogenicity, and disease biomarkers.
• Define plans for assay development and validation across non-GLP, GLP, and GCLP studies with ICH M10 and fit-for-purpose concepts.
• Lead vendor/CRO selection, assay transfer, validation planning, troubleshooting, and oversight of external labs.

Kenntnisse

Biomarker development

Bioanalytical assay development

Method validation

Data interpretation

Team leadership

Vendor management

Molecular biology

Ausbildung

PhD in biology or related field

Tools

qPCR/ddPCR

ELISA/MSD

Flow cytometry

NGS

AAV/LNP knowledge

Jobbeschreibung

Arbor Biotechnologies is seeking an Associate Director, Bioanalytical Sciences & Biomarkers to lead assay strategy, development, validation, and non-clinical and clinical sample analysis for in vivo gene editing programs from IND-enabling studies through clinical trials.

Reporting to the Senior Director, Translational Research, you will serve as the assay lead on cross-functional program teams, oversee a 3-4 member in-house team, and ensure assays are rigorous, compliant (GLP/GCLP), and deliver