Medical Director

About Cartesian Therapeutics

Cartesian Therapeutics is a clinical-stage biopharmaceutical company pioneering mRNA-engineered CAR-T cell therapies for severe autoimmune diseases. Our lead asset, Descartes-08, an anti-BCMA autologous mRNA CAR-T therapy, has received RMAT designation for generalized myasthenia gravis (gMG) and is currently being evaluated across a portfolio of clinical programs:

AURORA - Phase 3 randomized, double-blind, placebo-controlled trial in gMG

TRITON - Phase 2 randomized controlled trial in dermatomyositis and antisynthetase syndrome

HELIOS - Phase 1/2 trial in juvenile dermatomyositis

Planned in vivo CAR-T program in the United States - early-stage strategic development

We are a data-driven organization committed to rigorous clinical science, regulatory excellence, and rapid translation of breakthrough therapies to patients with limited treatment options.

Position Summary

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, and 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.

Organizational Context

Reports To

Vice President, Head of Clinical Development

Level

Director

Location

Frederick, MD - Open to remote location

Travel

Up to 15%

Key Responsibilities

Phase 3 Program Support - AURORA (Myasthenia Gravis)

Serve as sponsor medical monitor for the Phase 3 AURORA study in generalized myasthenia gravis

Review subject eligibility, protocol deviations, dose interruptions, and significant safety events in collaboration with the CRO medical monitor and investigative sites

Provide medical oversight for safety signal detection, adverse event adjudication, and ongoing benefit-risk assessment

Collaborate with Cartesian's medical director of pharmacovigilance

Participate in DSMB activities, including preparation and review of medical and safety data summaries

Phase 2 Program Support - TRITON (Dermatomyositis/Antisynthetase Syndrome)

Provide day-to-day medical monitoring oversight for the TRITON study

Partner closely with Clinical Operations to support protocol compliance, and investigator engagement

Ensure participant safety through the review of safety data, laboratory trends, protocol compliance

Assist in development of clinical narratives, safety summaries, and clinical sections of regulatory documents

Collaborate with Biostatistics and Data Management teams in ongoing blinded and unblinded data review activities

Participate in DSMB Meetings

Phase 1/2 Program Support - HELIOS (Juvenile Dermatomyositis)

Contribute to protocol amendments, including updates to safety monitoring frameworks, and evaluations in the pediatric population

Partner closely with Clinical Operations to support protocol compliance, and investigator engagement

Review safety data, laboratory trends

Assist in development of clinical narratives, safety summaries, and clinical sections of regulatory documents

Collaborate with Biostatistics and Data Management teams in ongoing blinded and unblinded data review activities

Participate in Safety Monitoring Committee (SMC) meetings, and contribute to medical review of cumulative safety data and emerging safety signals in collaboration with the pharmacovigilance medical monitor

In Vivo CAR-T Program - Strategic Planning

Participate in clinical trial design strategy for Cartesian's planned in vivo CAR-T program in the United States

Advise on Phase 1/2 study design, dose escalation frameworks and safety monitoring

Contribute medical input to pre-IND and Type B meeting packages, including safety monitoring strategies and clinical development planning

Regulatory and Cross-Functional Contributions

Contribute to regulatory submissions and briefing documents requiring medical input, including Type B/C meeting packages, IND amendments, and BLA preparation

Collaborate with Clinical Operations, Regulatory Affairs, Pharmacovigilance, Biostatistics, Medical Affairs, and Translational Medicine as a medical expert across programs

Qualifications

Education

MD or DO required

Board certification or board eligibility in neurology, rheumatology, immunology, internal medicine, hematology/oncology, or related specialty preferred

Experience

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

Technical Competencies

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

Leadership and Interpersonal Skills

Ability to operate effectively as both a strategic thought partner and hands-on technical contributor in a small company environment

Strong written and verbal communication skills; able to translate complex medical and scientific concepts for clinical, regulatory, and executive audiences

Collaborative and solution-oriented; comfortable managing multiple programs simultaneously in a fast-moving biotech setting

Why Cartesian Therapeutics

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