Director, Bioanalytical / Biomarkers

Vor Bio•Boston, MA

4d•Hybrid

About The Position

The Director, Bioanalytical / Biomarkers will lead the strategy, development, and execution of bioanalytical and biomarker assays to support clinical development programs. This role is responsible for advancing translational insights, enabling decision-making through high-quality data, and ensuring regulatory-compliant bioanalytical operations across studies.

Requirements

PhD in Biology, Pharmacology, Immunology, Bioanalytical Sciences, or related field (or MS with significant experience)
10+ years of experience in bioanalysis and/or biomarker development in biotech/pharma
Deep expertise in bioanalytical assays (e.g., LC-MS/MS, ELISA, flow cytometry, qPCR, NGS, cell-based assays)
Strong understanding of PK/PD, immunogenicity, and translational science principles
Experience supporting clinical-stage programs and regulatory filings
Proven track record managing CROs and external partnerships
Strong leadership, communication, and project management skills

Nice To Haves

Experience in [oncology, cell/gene therapy, immunology — tailor as needed]
Familiarity with companion diagnostics or advanced biomarker platforms
Prior team leadership or people management experience

Responsibilities

Define and execute bioanalytical and biomarker strategies across preclinical and clinical programs
Align biomarker plans with clinical, regulatory, and development objectives
Serve as a subject matter expert in bioanalysis and translational biomarkers
Oversee development, validation, and implementation of bioanalytical assays (e.g., PK, ADA, cell-based, molecular assays)
Guide biomarker assay selection and fit-for-purpose validation strategies
Ensure assay performance meets regulatory and scientific standards
Select and manage CROs and external labs for bioanalytical and biomarker activities
Oversee timelines, budgets, and deliverables across studies
Ensure high-quality data generation and timely reporting
Partner with Clinical Operations and Clinical Development to integrate biomarker endpoints into study design
Review and interpret biomarker and PK/PD data to inform program decisions
Contribute to clinical study protocols, SAPs, and reports
Ensure compliance with GLP/GCP and regulatory guidance (FDA, EMA)
Contribute to regulatory submissions (INDs, BLAs, briefing packages)
Represent bioanalytical/biomarker strategy in regulatory interactions as needed
Work closely with Translational Sciences, Clinical Pharmacology, Regulatory, and CMC teams
Communicate complex data and insights to internal stakeholders and leadership