Medical Director
Remote · Frederick, Maryland, United States
Job Summary
Medical Director to provide medical oversight as sponsor medical monitor for Cartesian Therapeutics' autoimmune and cell-therapy clinical programs. Lead oversight across Phase 3 AURORA, Phase 2 TRITON, Phase 1/2 HELIOS trials, and strategic planning for in vivo CAR-T programs; review eligibility, protocol deviations, and safety events; oversee safety surveillance, signal detection, and adverse event adjudication; contribute to clinical narratives, safety summaries, and regulatory documents; collaborate with CROs, data management, biostatistics, regulatory affairs, and pharmacovigilance; participate in DSMB/SMC activities; support IND/BLA preparations and submissions; travel up to 15%.
Required Qualifications
- 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 desirable but not required
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