Senior Director, Biomarker Development, Strategy and Operations (Waltham)

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 FcγRIIb, 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 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!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 LeadershipDefine and lead a portfolio-wide biomarker strategy aligned with program goals, clinical endpoints, and regulatory pathwaysEstablish biomarker frameworks spanning target engagement, PK/PD, and mechanism-of-action, disease biology, predictive, prognostic, and pharmacodynamic biomarkersIntegrate preclinical, clinical, and emerging real-world data to drive indication selection and patient enrichment strategiesEnsure biomarker strategies support differentiation, value demonstration, and lifecycle management of assetsServe as biomarker SME on cross-functional program teams, shaping study design and endpoint selectionBiomarker Development & Assay LeadershipOversee 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 platformsBiomarker Operations & ExecutionOwn 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 executionLead outsourcing strategy including assay transfer, validation, and execution at external partnersEnsure high-quality, timely data delivery, including rigorous QC and data reviewGuide incorporation of biomarkers into clinical protocols, statistical analysis plans, and regulatory documentation (IND/CTA/BLA/NDA)External Partnerships & Scientific LeadershipIdentify, select, and manage external collaborators (CROs, diagnostic companies, academic institutions)Serve as external-facing scientific leader in biomarker strategy and translational medicineSupport business development through scientific due diligence and biomarker strategy evaluationContribute to scientific publications, conferences, and regulatory interactionsQualifications: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 rolesDemonstrated success supporting both early and late-stage clinical development programsDeep expertise in biomarker strategy and translational science, assay development and validation, and clinical biomarker implementatioProven people leadership experience, including direct supervision, mentoring, and development of high-performing translational or biomarker teamsStrong understanding of autoimmune/inflammatory disease biologyExperience integrating biomarker data into regulatory submissionsStrong operational leadership managing vendors, budgets, and timelinesExcellent communication and presentation skills, ability to translate complex data into actionable strategic insights in a clear and thorough manner for both verbal and written contextGoal-oriented, organized, capable of prioritizing and working on multiple projects, and able to execute to timelines that meet company goalsMotivated and curious with a demonstrated ability to work in multidisciplinary teams in a fast-paced, entrepreneurial, and technical settingFlexibility 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.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.