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Senior Clinical Research Scientist II

đź•’ May 26

🏄 California – Remote

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đź’µ $215k - $230k / year

⏰ Full Time

đźź  Senior

đź§Ş Clinical Research

🦅 H1B Visa Sponsor

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đź‘» Ghost score 30%

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Logo of Caribou Biosciences

Caribou Biosciences

51 - 200 employees

Founded 2011

🏥 Healthcare

đź’Ľ Consulting

🧬 Biotechnology

đź’° $125M Post-IPO Equity on 2023-07

Healthcare • Consulting • Biotechnology

Caribou Biosciences is a clinical-stage biopharmaceutical company focused on developing transformative genome-edited allogeneic cell therapies for treating devastating human diseases. Utilizing next-generation CRISPR genome-editing technologies, including their proprietary chRDNA (CRISPR hybrid RNA-DNA) technology, Caribou is at the forefront of precision genome editing. Their technologies allow for complex genome editing with superior specificity and precision, such as multiplex gene knockout and insertion while maintaining genomic integrity. Caribou is pioneering off-the-shelf CAR-T cell therapies from healthy donor cells to address limitations of current therapies. They use their cutting-edge technologies to enhance the effectiveness of cell therapies through strategies like checkpoint disruption and immune cloaking. Co-founded by Jennifer Doudna, a Nobel Prize recipient, Caribou Biosciences is recognized as a leader in the CRISPR field.

đź“‹ Description

• 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

🏖️ Benefits

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

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