Cartesian Therapeutics

Role Description Cartesian Therapeutics is seeking an experienced and strategically minded Director or Senior Director of Biostatistics to join our Clinical Development team. This is a senior individual contributor and people-management role with significant influence across all active clinical programs. Reporting to the Vice President of Clinical Development, this position provides statistical leadership from protocol design through data analysis, regulatory submission, and post-marketing planning. The successful candidate will serve as the internal statistical authority for Cartesian's portfolio, interface directly with regulatory agencies, oversee external statistical resources, and help shape the analytical strategy for our emerging in vivo CAR-T program. This role requires both technical depth and the ability to communicate complex statistical concepts clearly to clinical, regulatory, and executive stakeholders. Qualifications - Ph.D. in Biostatistics, Statistics, or a closely related field preferred - Master's degree in Biostatistics or Statistics required; candidates with a Master's degree must have 5-10 years of relevant industry experience to be considered at the Director level - Ph.D. candidates: minimum 5 years of pharmaceutical/biotech industry experience, including experience leading statistical activities on at least one Phase 2 or Phase 3 clinical trial - Master's candidates: at least 10 years of pharmaceutical/biotech industry experience preferred with demonstrated progression to senior statistical leadership roles - Direct experience authoring or reviewing SAPs for randomized controlled trials required; Phase 3 SAP experience strongly preferred - Experience supporting DSMB or Data Safety Committees - Demonstrated experience managing or directing CRO statisticians and/or external statistical consultants - Familiarity with CDISC standards (SDTM, ADaM) and regulatory expectations for submission-ready datasets - Prior experience contributing to FDA regulatory submissions (IND amendments, meeting packages, BLA/NDA modules) is strongly preferred Requirements - Expert proficiency in SAS; R or Python experience valued - Working knowledge of clinical trial design methods including adaptive designs, group sequential methods, and Bayesian approaches - Experience with mixed-effects models, repeated measures analyses, and handling of missing data (multiple imputation, sensitivity analyses) in the context of chronic disease clinical trials - Familiarity with estimand framework (ICH E9(R1)) and its application to protocol and SAP development Benefits - Work at the intersection of cell therapy innovation and clinical biostatistics - an environment where statistical rigor directly shapes development decisions - High-visibility role with direct engagement across all pipeline programs, including a Phase 3 trial with RMAT designation and SPA agreement - Opportunity to help build statistical infrastructure at a pivotal stage of company growth, from Phase 3 execution through potential BLA submission - Competitive compensation, equity participation, and comprehensive benefits - Collaborative, science-driven culture with direct access to senior leadership

Role Description Cartesian Therapeutics is seeking an experienced and motivated Medical Director to join the Clinical Development team. Reporting to the Vice President, Head of Clinical Development, this individual will function as the sponsor medical monitor across Cartesian's clinical-stage autoimmune and cell therapy programs. The successful candidate will: - Provide medical oversight for clinical trials - Contribute to protocol development and execution - Support safety surveillance and signal detection activities - Contribute to the clinical sections of regulatory documents This role requires strong scientific and clinical judgment, experience in early- and late-stage clinical development, and the ability to work collaboratively in a fast-paced biotechnology environment. Qualifications - MD or DO required - Board certification or board eligibility in neurology, rheumatology, immunology, internal medicine, hematology/oncology, or related specialty preferred - Minimum 3 years of pharmaceutical or biotechnology industry experience - Prior sponsor medical monitoring experience required - Experience supporting Phase 1–3 clinical trials in biotechnology or pharmaceutical settings required - Experience in autoimmune disease, immunology, neurology, rheumatology, hematology/oncology, or cell therapy preferred - Familiarity with FDA regulations, ICH-GCP guidelines, and safety reporting requirements - Experience interacting with CROs, investigators, DSMBs, and regulatory agencies preferred - Experience with cellular therapies, immune-mediated toxicities are desirable but not required Requirements - Strong understanding of clinical trial conduct, medical monitoring, and safety surveillance in early- and late-stage development - Familiarity with interpretation of laboratory abnormalities and emerging safety signals - Working knowledge of clinical trial methodology, dose escalation strategies, and safety monitoring frameworks - Ability to interpret clinical data listings and collaborate with Biostatistics and Data Management teams during ongoing data review Benefits - Work at the forefront of mRNA-engineered CAR-T cell therapy development for severe autoimmune diseases - High-visibility role with direct engagement across all pipeline programs, including a Phase 3 trial with RMAT designation and SPA agreement - Opportunity to help shape medical and clinical development strategy at a pivotal stage of company growth - Competitive compensation, equity participation, and comprehensive benefits - Collaborative, science-driven culture with direct access to senior leadership