Principal Scientist, Nonclinical Development and Translational SciencesPosition Summary:The Principal Scientist, Nonclinical Development and Translational Sciences, will provide scientific and technical leadership for the development of innovative in vivo cell and gene therapies for autoimmune diseases. Reporting to the VP, Head of Discovery Research, this individual will design and oversee IND-enabling pharmacology, biodistribution, and toxicology studies and contribute to translational and nonclinical development strategies. The successful candidate will combine expertise in immunology, nonclinical drug development, and regulatory science to advance programs from candidate selection through IND submission and early clinical development.
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 to support 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.
Required Qualifications- DVM, PhD, or equivalent advanced degree in a relevant life science discipline.
- 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.
Preferred Qualifications:- 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.
Work Environment: This 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.
Salary Notice:At Cartesian Therapeutics, we are committed to transparency and equity in our compensation practices. The salary range for this position is $160,000 - 185,000 per year. This position is also eligible for an annual bonus and equity within the company. Please note that the final compensation will be determined based on several factors, including but not limited to years of experience, industry experience, education, and specific skills relevant to the role. We believe in rewarding our team members fairly and encourage open discussions about compensation throughout the hiring process. Please, no agency or recruiter inquiries. Unsolicited resumes will not be accepted and no fees will be paid for unsolicited candidates.
