Medical Director

Cartesian Therapeutics•Frederick, MD

10d•Remote

About The Position

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.

Requirements

MD or DO required
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
Familiarity with FDA regulations, ICH-GCP guidelines, and safety reporting 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
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

Nice To Haves

Board certification or board eligibility in neurology, rheumatology, immunology, internal medicine, hematology/oncology, or related specialty preferred
Experience in autoimmune disease, immunology, neurology, rheumatology, hematology/oncology, or cell therapy preferred
Experience interacting with CROs, investigators, DSMBs, and regulatory agencies preferred
Experience with cellular therapies, immune-mediated toxicities are desirable but not required

Responsibilities

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