Senior Director, Biomarker Development, Strategy and Operations
Zenas BioPharma
August 07, 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.
Key Responsibilities:
- Define and lead a portfolio-wide biomarker strategy aligned with program goals, clinical endpoints, and regulatory pathways.
- Establish biomarker frameworks (target engagement, PK/PD, MoA, disease biology, predictive/prognostic, pharmacodynamic).
- Integrate preclinical, clinical, and real-world data to drive indication selection and patient enrichment.
- Serve as a biomarker SME to shape study design and endpoint selection.
- Oversee development, qualification, validation, and lifecycle management of biomarker assays (exploratory to regulatory-grade).
- Lead assay strategy across modalities (e.g., flow cytometry, genomics, proteomics).
- Own end-to-end biomarker operations (vendor selection/oversight, budgeting, timelines, risk, sample logistics, assay execution).
- Lead outsourcing (assay transfer, validation, execution) and ensure QC/data review.
- Guide biomarker incorporation into protocols, SAPs, and regulatory documents (IND/CTA/BLA/NDA).
- Identify and manage external collaborators; serve as external-facing scientific leader.
- Support business development via scientific due diligence and biomarker strategy evaluation.
- Contribute to publications, conferences, and regulatory interactions.
Qualifications:
- Ph.D. in Immunology, Molecular Biology, Translational Medicine, or related field (or MS with 12+ years industry experience).
- 8+ years biotech/pharma experience in biomarker/translational leadership.
- Proven success across early and late-stage clinical development.
- 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.
- Excellent communication/presentation skills; translates complex data into actionable insights.
- Goal-oriented, organized, able to prioritize multiple projects and execute to timelines.
- Motivated, curious; effective in multidisciplinary, fast-paced technical settings.
- Flexibility for non-traditional hours due to international operations.
Benefits/Compensation:
- Competitive compensation and benefits package; base salary range $227,000 to $283,785 (plus annual bonus, equity, full range of benefits, and other incentives).
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.
Key Responsibilities:
- Define and lead a portfolio-wide biomarker strategy aligned with program goals, clinical endpoints, and regulatory pathways.
- Establish biomarker frameworks (target engagement, PK/PD, MoA, disease biology, predictive/prognostic, pharmacodynamic).
- Integrate preclinical, clinical, and real-world data to drive indication selection and patient enrichment.
- Serve as a biomarker SME to shape study design and endpoint selection.
- Oversee development, qualification, validation, and lifecycle management of biomarker assays (exploratory to regulatory-grade).
- Lead assay strategy across modalities (e.g., flow cytometry, genomics, proteomics).
- Own end-to-end biomarker operations (vendor selection/oversight, budgeting, timelines, risk, sample logistics, assay execution).
- Lead outsourcing (assay transfer, validation, execution) and ensure QC/data review.
- Guide biomarker incorporation into protocols, SAPs, and regulatory documents (IND/CTA/BLA/NDA).
- Identify and manage external collaborators; serve as external-facing scientific leader.
- Support business development via scientific due diligence and biomarker strategy evaluation.
- Contribute to publications, conferences, and regulatory interactions.
Qualifications:
- Ph.D. in Immunology, Molecular Biology, Translational Medicine, or related field (or MS with 12+ years industry experience).
- 8+ years biotech/pharma experience in biomarker/translational leadership.
- Proven success across early and late-stage clinical development.
- 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.
- Excellent communication/presentation skills; translates complex data into actionable insights.
- Goal-oriented, organized, able to prioritize multiple projects and execute to timelines.
- Motivated, curious; effective in multidisciplinary, fast-paced technical settings.
- Flexibility for non-traditional hours due to international operations.
Benefits/Compensation:
- Competitive compensation and benefits package; base salary range $227,000 to $283,785 (plus annual bonus, equity, full range of benefits, and other incentives).