Senior Medical Director – MD Required

🔥 6 minutes ago

🦀 Maryland – Remote

🦀 Maryland – Remote

💵 $207k - $380k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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AbelZeta

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2009

🧬 Biotechnology

💊 Pharmaceuticals

💰 $120M Later Stage VC (Series A) on 2021-09

Biotechnology • Pharmaceuticals

AbelZeta is a clinical-stage biopharmaceutical company (presenting itself as AbelZeta Pharma) focused on developing cell-based oncology therapies. Public information shows they recently regained global rights to C-CAR039 (Prizlon-cel), a CAR-T cell therapy candidate, and received FDA clearance of an IND application to study it in large B‑cell lymphoma, indicating an emphasis on hematologic cancer therapeutics and clinical development/licensing activities.

📋 Description

• Serve as Study Medical Lead for one or more clinical trials • 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, SAEs, concomitant medications, rescue therapy review, protocol deviations, and data queries • Review subject-level clinical data in EDC and related data-review platforms • Provide medical guidance to investigators and sites on protocol interpretation, eligibility, disease management, safety events, and study-specific clinical questions • Lead or contribute to 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 and propose mitigation strategies to ensure high-quality, timely, inspection-ready trial execution • Participate in and increasingly help lead regulatory interactions related to expedited programs, protocol alignment, pivotal development, and registrational strategy • Build relationships with investigators, key opinion leaders, advisory boards, patient advocacy organizations, and external experts • Develop expertise in clinical and operational considerations unique to autologous CAR-T and other advanced therapies • Partner with Safety and clinical experts on CRS, ICANS/neurotoxicity, infections, cytopenias, and disease-specific complications • Partner with Clinical Operations, Data Management, Pharmacovigilance/Safety, Biostatistics, Translational Medicine, Regulatory Affairs, Medical Writing, CMC/Technical Operations, and CRO partners

🎯 Requirements

• MD, DO, or equivalent medical degree required • 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 • Ability to operate effectively in a highly matrixed, fast-moving environment • 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 • 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 • Ability to engage investigators and KOLs as a physician peer while maintaining sponsor accountability • Ability to collaborate across Clinical Operations, Safety, Regulatory, Biometrics, Translational Medicine, CMC, Research, and external partners • Ability to prioritize, make decisions with incomplete information, and operate effectively in a growing biotechnology company

🏖️ Benefits

• 100% company paid medical, dental, vision, life insurance, short-term and long-term disability insurance • Competitive company 401k match • Paid holidays, sick leave, and annual leave • Defined career path • Annual performance review and feedback process

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