Senior Director, Biomarker Development, Strategy and Operations

Senior Director, Biomarker Development, Strategy and Operations

Zenas is a clinical-stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients with autoimmune diseases. Zenas is advancing two late-stage, potential franchise molecules, obexelimab and orelabrutinib. Zenas' earlier stage programs include ZB021, a clinical-stage, potentially best-in-class, oral, IL-17AA/AF inhibitor; ZB022, a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor; and ZB014, a preclinical half-life extended anti-CD-19 and FcγRIIb monoclonal antibody.

We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. Our colleagues have an opportunity to engage in a fast-paced learning environment and experience individual and organizational success as we work towards becoming a global immunology and autoimmune disease leader, while living our values of Transparency, Relationships, Urgency, Excellence and Innovation – TRUE Innovation!

The Senior Director, Biomarker Development, Strategy, and Operations is a strategic and operational leader responsible for defining and executing an integrated biomarker vision across the portfolio. This role drives end-to-end biomarker strategy, assay development, translational science, and operational execution from early through late-stage clinical development.

The individual will serve as a key enterprise leader, ensuring biomarkers inform critical decisions across the portfolio, enabling precision medicine approaches and maximizing the value of therapeutic programs.

This role is highly cross-functional, requiring close partnership with Clinical Development, Translational Sciences, Clinical Operations, Regulatory, Medical Affairs, and Commercial teams, and leadership of external collaborations.

• Define and lead a portfolio-wide biomarker strategy aligned with program goals, clinical endpoints, and regulatory pathways
• Establish biomarker frameworks spanning target engagement, PK/PD, and mechanism-of-action, disease biology, predictive, prognostic, and pharmacodynamic biomarkers
• Integrate preclinical, clinical, and emerging real-world data to drive indication selection and patient enrichment strategies
• Ensure biomarker strategies support differentiation, value demonstration, and lifecycle management of assets
• Serve as biomarker SME on cross-functional program teams, shaping study design and endpoint selection
• Oversee the development, qualification, validation, and lifecycle management of fit-for-purpose biomarker assays (exploratory through regulatory-grade)
• Lead assay strategy across modalities (e.g., flow cytometry, genomics, proteomics)
• Ensure scientific rigor, reproducibility, and compliance across all biomarker platforms
• Own end-to-end biomarker operations across clinical studies, including vendor selection and oversight (CROs, central labs, diagnostics partners); budgeting, timelines, and risk management; sample flow logistics and assay execution
• Lead outsourcing strategy including assay transfer, validation, and execution at external partners
• Ensure high-quality, timely data delivery, including rigorous QC and data review
• Guide incorporation of biomarkers into clinical protocols, statistical analysis plans, and regulatory documentation (IND/CTA/BLA/NDA)
• Identify, select, and manage external collaborators (CROs, diagnostic companies, academic institutions)
• Serve as external-facing scientific leader in biomarker strategy and translational medicine
• Support business development through scientific due diligence and biomarker strategy evaluation
• Contribute to scientific publications, conferences, and regulatory interactions

• Ph.D. in Immunology, Molecular Biology, Translational Medicine, or related field (or equivalent experience), or MS degree with 15+ years relevant industry experience.
• 8+ years of biotech/pharma experience, including biomarker or translational leadership roles
• Demonstrated success supporting both early and…