JOBSEARCHER

Director, Bioanalytical / Biomarkers

Join Us in Tackling Autoimmune Disease at Its RootAt Vor, we believe science can do more than manage symptoms. It can change the course of disease. By advancing telitacicept, a first- and potentially best-in-class dual BAFF/APRIL inhibitor, we are silencing upstream survival signals and stopping downstream autoimmune cascades. Together, we are addressing disease at its root cause and rewriting what is possible for patients worldwide.When you join Vor, you're not just working on a medicine. You're part of a mission to redefine the future of autoimmune care.Why Work at Vor?Impact: Contribute directly to a medicine with best-in-disease Phase 3 results in myasthenia gravis and expansion into multiple autoimmune diseases.Growth: Be part of a rapidly scaling company with opportunities to grow your career in science, clinical development, commercial strategy, and beyond.Innovation: Work on a platform with potential beyond one indication - a therapy that has already shown consistent results across lupus, IgA nephropathy, and Sjögren's syndrome.Belonging: Join a culture where every voice is heard, and where our shared mission unites us across functions and geographies.Location: Boston, MA preferredThe Director, Bioanalytical / Biomarkers will lead the strategy, development, and execution of bioanalytical and biomarker assays to support clinical development programs. This role is responsible for advancing translational insights, enabling decision-making through high-quality data, and ensuring regulatory-compliant bioanalytical operations across studies.Key ResponsibilitiesStrategy & LeadershipDefine and execute bioanalytical and biomarker strategies across preclinical and clinical programsAlign biomarker plans with clinical, regulatory, and development objectivesServe as a subject matter expert in bioanalysis and translational biomarkersAssay Development & OversightOversee development, validation, and implementation of bioanalytical assays (e.g., PK, ADA, cell-based, molecular assays)Guide biomarker assay selection and fit-for-purpose validation strategiesEnsure assay performance meets regulatory and scientific standardsVendor & Study ManagementSelect and manage CROs and external labs for bioanalytical and biomarker activitiesOversee timelines, budgets, and deliverables across studiesEnsure high-quality data generation and timely reportingClinical Study SupportPartner with Clinical Operations and Clinical Development to integrate biomarker endpoints into study designReview and interpret biomarker and PK/PD data to inform program decisionsContribute to clinical study protocols, SAPs, and reportsRegulatory & ComplianceEnsure compliance with GLP/GCP and regulatory guidance (FDA, EMA)Contribute to regulatory submissions (INDs, BLAs, briefing packages)Represent bioanalytical/biomarker strategy in regulatory interactions as neededCross-functional CollaborationWork closely with Translational Sciences, Clinical Pharmacology, Regulatory, and CMC teamsCommunicate complex data and insights to internal stakeholders and leadership QualificationsPhD in Biology, Pharmacology, Immunology, Bioanalytical Sciences, or related field (or MS with significant experience)10+ years of experience in bioanalysis and/or biomarker development in biotech/pharmaDeep expertise in bioanalytical assays (e.g., LC-MS/MS, ELISA, flow cytometry, qPCR, NGS, cell-based assays)Strong understanding of PK/PD, immunogenicity, and translational science principlesExperience supporting clinical-stage programs and regulatory filingsProven track record managing CROs and external partnershipsStrong leadership, communication, and project management skillsPreferred QualificationsExperience in [oncology, cell/gene therapy, immunology - tailor as needed]Familiarity with companion diagnostics or advanced biomarker platformsPrior team leadership or people management experienceThe salary range for the Director, Bioanalytical / Biomarkers is expected to be between $210,000 and $230,000 per year. Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location.At Vor, we support our team with robust benefits, including comprehensive health coverage, flexible paid time off, generous parental leave, and a competitive 401(k). From education assistance to wellness resources and financial security, we invest in your well-being so you can thrive at work and beyond.As an equal opportunity employer, we at Vor Bio know that diversity inspires innovation, inclusiveness, and creativity. We invite you to come as you are. All applicants will be considered for employment agnostic to race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.