Principal Scientist, Nonclinical Development and Translational Sciences

Cartesian Therapeutics•Frederick, MD

17h•Onsite

About The Position

Cartesian Therapeutics is a late clinical-stage company pioneering cell therapy for autoimmune diseases. Its lead asset, Descartes-08, is a CAR-T therapy in Phase 3 development for generalized myasthenia gravis, Phase 2 development for myositis, including dermatomyositis and antisynthetase syndrome, and Phase 1/2 development for pediatric autoimmune diseases, including juvenile dermatomyositis. The Principal Scientist, Nonclinical Development and Translational Sciences, will provide scientific and technical leadership for developing innovative in vivo cell and gene therapies for autoimmune diseases. Reporting to the VP, Head of Discovery Research, this person will design and oversee IND-enabling pharmacology, biodistribution, and toxicology studies and contribute to translational and nonclinical development strategies. The successful candidate will bring expertise in immunology, nonclinical drug development, and regulatory science to advance programs from candidate selection through IND submission and early clinical development. The position is based in Frederick, Maryland and requires regular onsite laboratory presence. Limited domestic and international travel may be required to support CRO oversight, scientific conferences, and partner engagements. The annual salary range is $160,000–$185,000. The role is also eligible for an annual bonus and company equity. Final compensation depends on factors including experience, education, and relevant skills.

Requirements

DVM, PhD, or equivalent advanced degree in a relevant life science discipline.
At least 8 years of biotechnology, pharmaceutical, or regulatory experience in nonclinical drug development.
Experience designing and overseeing pharmacology, toxicology, PK/PD, biodistribution, and bioanalytical studies supporting regulatory submissions.
Strong understanding of nonclinical risk assessment, GLP, and FDA, EMA, and ICH regulatory requirements.
Experience authoring and reviewing nonclinical regulatory documents, including INDs, CTAs, and Investigator Brochures.
Experience selecting, managing, and overseeing external CROs and nonclinical studies.
Strong background in immunology, autoimmune disease, and translational research.
Experience with advanced therapeutic modalities, including cell and gene therapies, engineered immune cell therapies, CAR-T, T-cell engagers, or related immune-modulating therapies.

Nice To Haves

Experience with cell and gene therapies, including mRNA, LNP, and in vivo cell therapy platforms.
Experience with humanized mouse models, translational biomarker development, and FIH dose selection.
Experience evaluating cytokine release, immunogenicity, biodistribution, and off-target risks of engineered immune cell therapies.

Responsibilities

Contribute to nonclinical development strategies for cell and gene therapy programs from candidate nomination through IND submission.
Design, oversee, and interpret pharmacology, biodistribution, safety, and toxicology studies, including GLP-compliant studies as appropriate.
Develop translational strategies supporting candidate selection, dose selection, biomarker development, and clinical translation.
Integrate nonclinical data to inform program decisions, risk assessments, and regulatory submissions.
Support preparation of regulatory submissions and author or review nonclinical sections of INDs, CTAs, Investigator Brochures, and related regulatory documents.
Ensure studies and documentation comply with applicable regulatory requirements and GLP standards.
Select, manage, and oversee CROs and external collaborators supporting nonclinical development activities.
Provide scientific expertise in advanced therapeutic modalities, including cell and gene therapies, mRNA, and LNP-based platforms.
Collaborate cross-functionally with Discovery, Regulatory Affairs, Clinical Development, and CMC teams.
Mentor and develop scientists, fostering technical excellence, scientific rigor, and accountability.