Senior Clinical Research Scientist II
New
C
Caribou Biosciences, Inc.Biotechnology
Remote, Berkeley, California, United States, RemoteFull-TimeSenior
Salary215,000 - 230,000 USD per year
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Job Details
- Experience
- PhD/PharmD with 5+ years, MA/MS/MSN with 8+ years, or BA/BS/BSN with 10+ years of experience
- Required Skills
- GCP
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
- Ability to analyze and synthesize complex clinical and biomarker data
- Ability to travel 30% based on business needs
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
- Lead safety monitoring activities including review of adverse events and CAR-T associated toxicities
- Drive cross-functional collaboration with Clinical Operations, Translational Sciences, Data Management, Biostatistics, Regulatory, and CMC teams
- Lead authorship of key study documents, including protocols, Investigator’s Brochures, clinical study reports, regulatory documents, and safety narratives
- Integrate clinical and translational 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
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