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. 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
Qualifications:
- 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
Nice-to-haves:- Experience in fast paced biotech environment
- Experience with product launch or late stage development activities
Caribou compensation and benefits include:- Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
- Salary Range: $215,000 - $230,000. This represents the present low and high end of the Company's pay range for this position. Actual pay will vary based on various factors, including but not limited to location, skill, experience, and performance.
- 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
The benefits and stock purchase described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.
