Medical Director

About reputed company Therapeutics reputed company Therapeutics is a clinical-stage biopharmaceutical company pioneering mRNA-engineered CAR-T cell therapies for severe autoimmune diseases. Our reputed company 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: reputed company - 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 reputed company, and rapid translation of breakthrough therapies to patients with limited treatment options. Position Summary reputed company Therapeutics is seeking an reputed company 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 reputed company's clinical-stage autoimmune and cell therapy programs. The successful candidate will reputed company medical reputed company 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 - reputed company to remote location Travel Up to 15%

Key Responsibilities

Phase 3 Program Support - reputed company (Myasthenia Gravis) Serve as sponsor medical monitor for the Phase 3 reputed company study in generalized myasthenia gravis Review subject eligibility, protocol deviations, reputed company interruptions, and significant safety events in collaboration with the CRO medical monitor and investigative sites reputed company medical reputed company for safety signal detection, adverse event adjudication, and ongoing benefit-risk assessment Collaborate with reputed company'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) reputed company day-to-day medical monitoring reputed company 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 reputed company's planned in vivo CAR-T program in the United States Advise on Phase 1/2 study design, reputed company 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 reputed company 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, reputed company 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; reputed company to translate reputed company 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 reputed company Therapeutics Work at the forefront of mRNA-engineered CAR-T cell therapy development for severe autoimmune diseases High-visibility role with direct engagement across reputed company 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 reputed company to senior leadership Apply To This Job