Position Summary:

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.

Key Responsibilities:

Biomarker Strategy & Portfolio Leadership

• 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

Biomarker Development & Assay Leadership

• 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

Biomarker Operations & Execution

• 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)

External Partnerships & Scientific Leadership

• 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

Qualifications:

• 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 late-stage clinical development programs
• Deep expertise in biomarker strategy and translational science, assay development and validation, and clinical biomarker implementatio
• Proven people leadership experience, including direct supervision, mentoring, and development of high-performing translational or biomarker teams
• Strong understanding of autoimmune/inflammatory disease biology
• Experience integrating biomarker data into regulatory submissions
• Strong operational leadership managing vendors, budgets, and timelines
• Excellent communication and presentation skills, ability to translate complex data into actionable strategic insights in a clear and thorough manner for both verbal and written context
• Goal-oriented, organized, capable of prioritizing and working on multiple projects, and able to execute to timelines that meet company goals
• Motivated and curious with a demonstrated ability to work in multidisciplinary teams in a fast-paced, entrepreneurial, and technical setting
• Flexibility to work non-traditional work hours when needed, given international operations across time zones

#LI-Hybrid

The position is eligible for a competitive compensation and benefits package.

Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $227,000 to $283,785. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.

Zenas believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Zenas' competitive total rewards strategy that also includes annual performance bonus, equity, full range of benefits and other incentive compensation plans.