Senior Clinical Research Scientist II

The Senior Clinical Research Scientist II plays a key role in the clinical development of allogeneic CAR-T therapies for hematologic malignancies, including lymphoma, leukemia, and multiple myeloma. They are responsible to lead study-level activities and contribute to clinical strategy, driving the design, execution, and interpretation of early-phase clinical trials. The candidate is expected to partner cross-functionally to ensure high-quality data generation, advance innovative therapies, and support regulatory submissions.

Responsibilities

Lead clinical study in execution, including planning, conduct, data review, and reporting for Phase I and II trials in hematologic malignancies; Own ongoing clinical data review, ensuring patient safety and data integrity; identify trends and drive data informed decisions; Lead safety monitoring activities including review of adverse events and CAR-T associated toxicities (ie: CRS, ICANS) and contribute to dose escalation decisions; Drive cross-functional collaboration with Clinical Operations, Translational Sciences, Data Management, Biostatistics, Regulatory, and CMC teams to ensure high-quality study execution; Lead authorship of key study documents, including protocols, Investigator's Brochures, clinical study reports, regulatory documents, and safety narratives; Integrate clinical and translational data (ie: cell expansion, persistence, biomarker data) to generate insights and inform program strategy; Contribute to regulatory strategy and submissions, including IND-related documents and health authority responses; Serve as a scientific lead at the study level, engaging with investigators, CROs, and key opinion leaders; Support development of publications, abstracts, and presentations for scientific conferences; Ensure compliance with GCP, internal SOPs, and regulatory requirements

Requirements

PhD/PharmD with 5+ years of experience in clinical development; MA/MS/MSN and 8+ years of experience; BA/BS/BSN and 10+ years of experience; Experience in hematology-oncology drug development; Experience with CAR-T or cell therapy development; Demonstrated ownership of clinical studies, preferably early phase trials; Strong scientific writing and communication skills; Experience with GCP and regulatory requirements; Experience with clinical data review and interpretation (including data listings); Ability to analyze and synthesize complex clinical and biomarker data; Ability to travel 30% based on business needs; Legal authorization to work in the United States

Nice to have

Experience in fast paced biotech environment; Experience with product launch or late stage development activities

Benefits

Comprehensive compensation package including competitive salary, bonus, and equity; Generous paid vacation time in addition to company-observed holidays; Excellent medical, dental, and vision insurance; 401(k) retirement savings plan with matching employer contributions; Employee stock purchase plan (ESPP); Tuition reimbursement program