(Senior) Medical Director (MD Required)

AbelZeta; Rockville (MD); On-site; USD 180,000 - 240,000; Full time

Job summary

AbelZeta seeks a physician clinical developer to join the Inflammation & Immunology Clinical Development team in Rockville, MD. The role may be appointed at Medical Director or Senior Medical Director level based on depth of clinical development experience and leadership scope.

The successful candidate will lead clinical trials, provide day-to-day medical oversight, and contribute to protocol design, investigator engagement, safety oversight, data interpretation, and regulatory support as

Qualifications

• MD/DO or equivalent medical degree.
• Board certification/eligibility in Rheumatology, Neurology, Neuroimmunology/Multiple Sclerosis, Clinical Immunology, or related autoimmune specialty.
• Meaningful clinical experience with autoimmune, rheumatologic, or neuroimmunology disease.
• Demonstrated understanding of clinical-trial methodology, GCP, patient safety, and clinical data interpretation.
• Strong written and verbal communication in a fast-moving, matrixed environment.

Responsibilities

• Provide study-level medical leadership and monitoring for autoimmune/neuroimmunology trials.
• Oversee protocol design, investigator engagement, safety oversight, and data interpretation.
• Review subject-level clinical data in EDC and related platforms; guide investigations and safety management.
• Lead regulatory interactions related to trial development and registrations.

Skills

Clinical development leadership

GCP & trial methodology

Medical monitoring

Regulatory interactions

Cross-functional collaboration

Education

MD/DO or equivalent medical degree

Tools

EDC systems

Job description

AbelZeta is a clinical stage biopharmaceutical company focused on the development of novel immunotherapy products. We are on a rapid growth trajectory and have a highly energized and accomplished team driving to new frontiers of care for cancer and autoimmune disease patients.

We are seeking a physician clinical developer to join the Inflammation & Immunology Clinical Development organization. The role may be appointed at the Medical Director, or Senior Medical Director level depending on the candidate's depth of clinical development experience, therapeutic-area expertise, and demonstrated leadership scope.

The successful candidate will initially provide study-level clinical leadership and medical monitoring for one or more autoimmune and/or neuroimmunology trials, with meaningful responsibility for protocol design, study execution, investigator engagement, safety oversight, data interpretation, and regulatory support.

This role offers the opportunity to join a rapidly evolving clinical-stage cell-therapy organization at a point when programs are transitioning from early clinical evidence into global and potentially registrational development. The successful candidate can build deep expertise in autoimmune cell therapy while progressively expanding from hands-on study leadership to broader clinical development ownership.

Responsibilities and Duties:

• Study Medical Leadership & Medical Monitoring Serve as Study Medical Lead for one or more clinical trials and provide day-to-day clinical oversight from study start-up through database lock and clinical study reporting.
• Perform or oversee medical monitoring activities, including eligibility review, AEs, SAE, concomitant medications, rescue therapy review, protocol deviation, data queries.
• Review subject-level clinical data in EDC and related data-review platforms
• Provide medical guidance to investigators and sites regarding protocol interpretation, eligibility, disease management, safety events, and study-specific clinical questions.

Protocol Design, Data Interpretation & Scientific Strategy:

• Lead or contribute to development of protocols, amendments, investigator brochures, informed consent forms, medical monitoring plans, clinical sections of statistical analysis plans, clinical study reports, and other core study documents.
• Integrate disease biology, clinical phenotype, standard of care, translational findings, PK/PD, biomarker data, and emerging safety/efficacy data into study-level decisions and future development strategy.
• Identify study risks, propose mitigation strategies, and help ensure high-quality, timely, and inspection-ready trial execution
• Participate in and, with increasing experience, help lead regulatory interactions related to expedited programs, protocol alignment, pivotal development, and registrational strategy.
• Build productive relationships with investigators, key opinion leaders, advisory boards, patient advocacy organizations, and external experts.

Cell Therapy & Cross-Functional Development:

• Develop expertise in the clinical and operational considerations unique to autologous CAR‑T and other advanced therapies, including leukapheresis, manufacturing/vein-to-vein coordination, lymphodepletion, infusion, acute toxicity management, cytopenias, infection risk, immune reconstitution, and long-term follow-up.
• Partner with Safety and clinical experts on assessment and management frameworks for CRS, ICANS/neurotoxicity, infections, cytopenias, and disease-specific complications.
• Partner closely with Clinical Operations, Data Management, Pharmacovigilance/Safety, Biostatistics, Translational Medicine, Regulatory Affairs, Medical Writing, CMC/Technical Operations, and CRO partners

Qualifications and Requirements:

• Required MD, DO, or equivalent medical degree.
• Board certification/board eligibility in Rheumatology, Neurology, Neuroimmunology/Multiple Sclerosis, Clinical Immunology, or another specialty with substantial autoimmune-disease expertise.
• Meaningful clinical experience caring for patients with autoimmune, rheumatologic, or neuroimmunology disease.
• Demonstrated understanding of clinical-trial methodology, GCP, patient safety, and clinical data interpretation.
• Strong written and verbal communication skills and the ability to operate effectively in a highly matrixed, fast-moving environment.

Preferred Qualifications:

• Industry clinical-development experience as a study physician, medical monitor, or clinical development experience; or academic clinical trial investigator
• Hands‑on medical monitoring and EDC/data‑review experience, including eligibility, AEs/SAEs, concomitant medications, protocol deviations, rescue therapy, and medical queries.
• Experience designing or executing Phase 1, Phase 1b/2, Phase 2, pivotal, or registrational clinical trials.
• Experience with CAR‑T, cell therapy, gene therapy, hematopoietic stem‑cell transplantation, immune effector‑cell therapy, or other advanced therapeutic modalities.
• Experience with biomarkers, tra