Senior Director, Biomarker Development, Strategy and Operations

Senior Director, Biomarker Development, Strategy and Operations

Waltham, MA

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. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Zenas is advancing two late-stage, potential franchise molecules, obexelimab and orelabrutinib. Obexelimab, Zenas' lead product candidate, is a bifunctional monoclonal antibody designed to bind both CD19 and Fc?RIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. We believe that obexelimab's unique mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. Orelabrutinib is a potentially best-in-class, highly selective CNS-penetrant, oral, small molecule Bruton's Tyrosine Kinase (BTK) inhibitor with the potential to address compartmentalized inflammation and disease progression in Multiple Sclerosis (MS). 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 Fc?RIIb 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 !

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 12+ 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 implementation
• 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

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 BioPharma is proud to be an equal opportunity employer. We are committed to fostering an environment where diversity is valued. All qualified applicants will receive consideration for employment based on merit, qualifications and the needs of the business.