Sr. Medical Director, Hematology/Oncology (MD Required)
Key details
- Location
- Rockville, MD, United States
- Work style
- Onsite
- Level
- Lead / Staff+
- Job type
- Full-time
- Function
- Healthcare
- Focus area
- other
- Posted
- 17h ago
Skills
About the role
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 Oncology Clinical Development organization. The successful candidate will initially provide study-level clinical leadership and medical monitoring for the C-CAR039 oncology program, an autologous CD20/CD19 CAR-T therapy being developed for relapsed/refractory large B-cell lymphoma (LBCL), 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 oncology 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, lymphoma management, safety events, and study-specific clinical questions.
- Partner closely with Clinical Operations, Data Management, Pharmacovigilance/Safety, Biostatistics, Translational Medicine, Regulatory Affairs, Medical Writing, CMC/Technical Operations, and CRO partners
- 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 lymphoma 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 oncology-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 Hematology, Medical Oncology, Hematology/Oncology, or another specialty with substantial expertise in hematologic malignancies.
- Meaningful clinical experience caring for patients with hematologic malignancies, particularly B-cell lymphomas such as relapsed/refractory LBCL.
- 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, translational medicine, precision medicine, pharmacodynamic endpoints, or mechanistically driven patient-selection strategies.
- Experience supporting regulatory submissions or direct health-authority interactions.
- Clinically credible: can engage investigators and KOLs as a physician peer while maintaining sponsor accountability.
- Collaborative: effective across Clinical Operations, Safety, Regulatory, Biometrics, Translational Medicine, CMC, Research, and external partners.
- Comfortable with ambiguity and urgency: able to prioritize, make decisions with incomplete information, and operate effectively in a growing biotechnology company
AbelZeta is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. AbelZeta validates right to work using E-Verify. Salary at AbelZeta is determined by various factors, including but not limited to location, the individual’s particular combination of education, knowledge, skills, competencies, and experience, as well as contract-specific affordability and organizational requirements. The estimate displayed represents the typical salary range for this position and is just one component of AbelZeta’s total compensation package for employees.
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