Location: Boston, MA preferred
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.
- 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
- 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
- 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.