Senior Director, Biomarker Development, Strategy and Operations
Zenas BioPharma
June 24, 2026
Remote friendly (Waltham, MA)
United States
Clinical Research and Development
Position Summary
The Senior Director, Biomarker Development, Strategy, and Operations is responsible for defining and executing an integrated biomarker vision across the portfolio, driving end-to-end biomarker strategy, assay development, translational science, and operational execution from early through late-stage clinical development. Leads enterprise-wide biomarker decision-making across programs and partners closely with Clinical Development, Translational Sciences, Clinical Operations, Regulatory, Medical Affairs, and Commercial teams, including external collaborations.
Key Responsibilities
- Define and lead portfolio-wide biomarker strategy aligned with program goals, clinical endpoints, and regulatory pathways.
- Establish biomarker frameworks (target engagement, PK/PD, mechanism-of-action, disease biology, predictive/prognostic, pharmacodynamic).
- Integrate preclinical, clinical, and real-world data for indication selection and patient enrichment.
- Oversee biomarker assay development/qualification/validation and lifecycle management (exploratory through regulatory-grade), including across modalities (e.g., flow cytometry, genomics, proteomics).
- Own end-to-end biomarker operations across clinical studies: vendor selection/oversight, budgeting, timelines, risk management, sample logistics, assay execution, outsourcing/assay transfer and validation.
- Ensure timely, high-quality data delivery with QC and data review; incorporate biomarkers into protocols, statistical analysis plans, and regulatory documentation (IND/CTA/BLA/NDA).
- Identify/manage external collaborators; serve as external scientific leader; support scientific due diligence; contribute to publications, conferences, and regulatory interactions.
Qualifications
- Ph.D. in Immunology, Molecular Biology, Translational Medicine, or related field (or equivalent) OR MS with 12+ years relevant industry experience.
- 8+ years in biotech/pharma with biomarker/translational leadership.
- Proven success supporting early and late-stage clinical programs.
- Deep expertise in biomarker strategy, translational science, assay development/validation, and clinical biomarker implementation.
- People leadership experience.
- Strong understanding of autoimmune/inflammatory disease biology.
- Experience integrating biomarker data into regulatory submissions.
- Operational leadership managing vendors, budgets, and timelines.
- Strong communication/presentation; can translate complex data into actionable insights.
- Organized, goal-oriented, able to prioritize multiple projects and meet timelines.
- Ability to work in multidisciplinary, fast-paced settings; flexible non-traditional hours as needed.
Benefits/Compensation
- Competitive compensation and benefits package. Base salary range: $227,000 to $283,785; total rewards include annual performance bonus, equity, full range of benefits, and other incentive plans.
The Senior Director, Biomarker Development, Strategy, and Operations is responsible for defining and executing an integrated biomarker vision across the portfolio, driving end-to-end biomarker strategy, assay development, translational science, and operational execution from early through late-stage clinical development. Leads enterprise-wide biomarker decision-making across programs and partners closely with Clinical Development, Translational Sciences, Clinical Operations, Regulatory, Medical Affairs, and Commercial teams, including external collaborations.
Key Responsibilities
- Define and lead portfolio-wide biomarker strategy aligned with program goals, clinical endpoints, and regulatory pathways.
- Establish biomarker frameworks (target engagement, PK/PD, mechanism-of-action, disease biology, predictive/prognostic, pharmacodynamic).
- Integrate preclinical, clinical, and real-world data for indication selection and patient enrichment.
- Oversee biomarker assay development/qualification/validation and lifecycle management (exploratory through regulatory-grade), including across modalities (e.g., flow cytometry, genomics, proteomics).
- Own end-to-end biomarker operations across clinical studies: vendor selection/oversight, budgeting, timelines, risk management, sample logistics, assay execution, outsourcing/assay transfer and validation.
- Ensure timely, high-quality data delivery with QC and data review; incorporate biomarkers into protocols, statistical analysis plans, and regulatory documentation (IND/CTA/BLA/NDA).
- Identify/manage external collaborators; serve as external scientific leader; support scientific due diligence; contribute to publications, conferences, and regulatory interactions.
Qualifications
- Ph.D. in Immunology, Molecular Biology, Translational Medicine, or related field (or equivalent) OR MS with 12+ years relevant industry experience.
- 8+ years in biotech/pharma with biomarker/translational leadership.
- Proven success supporting early and late-stage clinical programs.
- Deep expertise in biomarker strategy, translational science, assay development/validation, and clinical biomarker implementation.
- People leadership experience.
- Strong understanding of autoimmune/inflammatory disease biology.
- Experience integrating biomarker data into regulatory submissions.
- Operational leadership managing vendors, budgets, and timelines.
- Strong communication/presentation; can translate complex data into actionable insights.
- Organized, goal-oriented, able to prioritize multiple projects and meet timelines.
- Ability to work in multidisciplinary, fast-paced settings; flexible non-traditional hours as needed.
Benefits/Compensation
- Competitive compensation and benefits package. Base salary range: $227,000 to $283,785; total rewards include annual performance bonus, equity, full range of benefits, and other incentive plans.