Senior Clinical Research Scientist II
Caribou Biosciences
12 days ago
Remote friendly (Berkeley, CA)
United States
Clinical Research and Development
Summary:
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. Leads study-level activities and contributes to clinical strategy, driving design, execution, and interpretation of early-phase clinical trials. Partners cross-functionally to ensure high-quality data generation, advance therapies, and support regulatory submissions.
Responsibilities:
- Lead clinical study execution (planning, conduct, data review, reporting) for Phase I/II trials
- Own ongoing clinical data review to ensure patient safety and data integrity; identify trends and drive data-informed decisions
- Lead safety monitoring, including review of adverse events and CAR-T toxicities (CRS, ICANS); contribute to dose escalation decisions
- Collaborate cross-functionally with Clinical Operations, Translational Sciences, Data Management, Biostatistics, Regulatory, and CMC teams
- Lead authorship of key study documents (protocols, Investigator’s Brochures, clinical study reports, regulatory documents, safety narratives)
- Integrate clinical and translational data (cell expansion, persistence, biomarker data) to inform program strategy
- Contribute to regulatory strategy and submissions (IND documents; health authority responses)
- Serve as scientific lead at study level (investigators, CROs, key opinion leaders)
- Support publications, abstracts, and conference presentations
- Ensure compliance with GCP, internal SOPs, and regulatory requirements
Qualifications:
- PhD/PharmD with 5+ years; MA/MS/MSN with 8+ years; BA/BS/BSN with 10+ years in clinical development
- Experience in hematology-oncology drug development
- Experience with CAR-T or cell therapy development
- Demonstrated ownership of clinical studies (preferably early phase)
- Strong scientific writing and communication skills
- Experience with GCP and regulatory requirements
- Clinical data review and interpretation (including data listings)
- Ability to analyze and synthesize complex clinical and biomarker data
- Travel ~30%
Nice-to-haves:
- Fast-paced biotech experience
- Product launch or late-stage development experience
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. Leads study-level activities and contributes to clinical strategy, driving design, execution, and interpretation of early-phase clinical trials. Partners cross-functionally to ensure high-quality data generation, advance therapies, and support regulatory submissions.
Responsibilities:
- Lead clinical study execution (planning, conduct, data review, reporting) for Phase I/II trials
- Own ongoing clinical data review to ensure patient safety and data integrity; identify trends and drive data-informed decisions
- Lead safety monitoring, including review of adverse events and CAR-T toxicities (CRS, ICANS); contribute to dose escalation decisions
- Collaborate cross-functionally with Clinical Operations, Translational Sciences, Data Management, Biostatistics, Regulatory, and CMC teams
- Lead authorship of key study documents (protocols, Investigator’s Brochures, clinical study reports, regulatory documents, safety narratives)
- Integrate clinical and translational data (cell expansion, persistence, biomarker data) to inform program strategy
- Contribute to regulatory strategy and submissions (IND documents; health authority responses)
- Serve as scientific lead at study level (investigators, CROs, key opinion leaders)
- Support publications, abstracts, and conference presentations
- Ensure compliance with GCP, internal SOPs, and regulatory requirements
Qualifications:
- PhD/PharmD with 5+ years; MA/MS/MSN with 8+ years; BA/BS/BSN with 10+ years in clinical development
- Experience in hematology-oncology drug development
- Experience with CAR-T or cell therapy development
- Demonstrated ownership of clinical studies (preferably early phase)
- Strong scientific writing and communication skills
- Experience with GCP and regulatory requirements
- Clinical data review and interpretation (including data listings)
- Ability to analyze and synthesize complex clinical and biomarker data
- Travel ~30%
Nice-to-haves:
- Fast-paced biotech experience
- Product launch or late-stage development experience