Senior Medical Director – MD Required

This is a fully remote position, open to applicants in Maryland.

📋 Description

• Act as the Study Medical Lead for one or more clinical trials.

• Provide daily clinical oversight from the initiation of the study through database lock and clinical study reporting.

• Conduct or supervise medical monitoring activities, which include eligibility assessments, AEs, SAEs, concomitant medication reviews, rescue therapy evaluations, protocol deviations, and data queries.

• Analyze subject-level clinical data in EDC and related data-review platforms.

• Offer medical guidance to investigators and sites regarding protocol interpretation, eligibility criteria, disease management, safety events, and clinical inquiries specific to the study.

• Lead or assist in the development of protocols, amendments, investigator brochures, informed consent forms, medical monitoring plans, clinical sections of statistical analysis plans, clinical study reports, and other essential study documents.

• Incorporate disease biology, clinical phenotype, standard of care, translational findings, PK/PD, biomarker data, and emerging safety/efficacy information into decisions at the study level and future development strategies.

• Identify potential study risks and suggest mitigation strategies to ensure high-quality, timely, and inspection-ready trial execution.

• Engage in and progressively help lead regulatory interactions concerning expedited programs, protocol alignment, pivotal development, and registration strategies.

• Establish relationships with investigators, key opinion leaders, advisory boards, patient advocacy organizations, and external experts.

• Cultivate expertise in clinical and operational considerations specific to autologous CAR-T and other advanced therapies.

• Collaborate with Safety and clinical experts on issues related to CRS, ICANS/neurotoxicity, infections, cytopenias, and disease-specific complications.

• Work alongside Clinical Operations, Data Management, Pharmacovigilance/Safety, Biostatistics, Translational Medicine, Regulatory Affairs, Medical Writing, CMC/Technical Operations, and CRO partners.

⛳️ Requirements

• MD, DO, or an equivalent medical degree is required.

• Board certification or board eligibility in Rheumatology, Neurology, Neuroimmunology/Multiple Sclerosis, Clinical Immunology, or another specialty with significant expertise in autoimmune diseases.

• Substantial clinical experience in caring for patients with autoimmune, rheumatologic, or neuroimmunology conditions.

• Proven understanding of clinical trial methodologies, GCP, patient safety, and clinical data interpretation.

• Excellent written and verbal communication capabilities.

• Ability to function effectively in a highly matrixed, fast-paced environment.

• Experience in the industry clinical development as a study physician, medical monitor, or within clinical development; or as an academic clinical trial investigator.

• Practical experience in medical monitoring and EDC/data review.

• Experience in designing or conducting Phase 1, Phase 1b/2, Phase 2, pivotal, or registration clinical trials.

• Familiarity with CAR-T, cell therapy, gene therapy, hematopoietic stem cell transplantation, immune effector cell therapy, or other advanced therapeutic modalities.

• Experience with biomarkers, translational medicine, precision medicine, pharmacodynamic endpoints, or mechanistically driven patient selection strategies.

• Experience in supporting regulatory submissions or direct interactions with health authorities.

• Capability to engage investigators and KOLs as a physician peer while upholding sponsor accountability.

• Ability to collaborate across Clinical Operations, Safety, Regulatory, Biometrics, Translational Medicine, CMC, Research, and external partners.

• Skill in prioritizing tasks, making decisions with incomplete information, and operating effectively in a growing biotechnology company.

🏝️ Benefits

• 100% company-paid medical, dental, vision, life insurance, and both short-term and long-term disability insurance.

• Competitive 401k company match.

• Paid holidays, sick leave, and annual leave.

• Clearly defined career path.

• Annual performance review and feedback process.