Location: Boston, MA preferredThe 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.
Key Responsibilities- Strategy & Leadership
- 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
- Assay Development & Oversight
- 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
- Vendor & Study Management
- 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
- Clinical Study Support
- 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
- Regulatory & Compliance
- 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
- Cross-functional Collaboration
- Work closely with Translational Sciences, Clinical Pharmacology, Regulatory, and CMC teams
- Communicate complex data and insights to internal stakeholders and leadership
Qualifications- 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
Preferred Qualifications- 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
The salary range for the Director, Bioanalytical / Biomarkers is expected to be between $210,000 and $230,000 per year. Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location.
At Vor, we support our team with robust benefits, including comprehensive health coverage, flexible paid time off, generous parental leave, and a competitive 401(k). From education assistance to wellness resources and financial security, we invest in your well-being so you can thrive at work and beyond.
