Job description
Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our next-generation genome-editing technology enables superior precision to develop cell therapies that are armored to potentially improve activity against diseases. We believe the future of cell therapy is off-the-shelf, and we are advancing our pipeline of off-the-shelf, or allogeneic, cell therapies from our CAR-T cell therapy platform as readily available treatments for patients with hematologic malignancies.
Members of the Caribou herd open their minds to new ideas and welcome diverse perspectives. We proudly assert that teams do their best work when their members are personally engaged, their ideas are taken seriously, and contributions are recognized. Members of the herd work from our headquarters in Berkeley, California, or remotely.
Summary:
Caribou is seeking a Clinical Trial Manager (CTM) to join our growing Clinical Operations group. You will be responsible for the execution and oversight of clinical trials from start-up through close-out, ensuring alignment with ICH-GCP, applicable regulations, internal SOPs, and protocols. The CTM will collaborate cross-functionally, manage vendors and sites, and contribute to high-quality clinical trial delivery.
The CTM will report to the Director of Clinical Operations. This position can be onsite, hybrid or remote.
Responsibilities:
Study Planning & Start-Up
- Support feasibility assessments, site selection, and study start-up activities
- Contribute to the development and review of protocols, ICFs, and trial-related documentation
- Lead creation and maintenance of study trackers, timelines, and study-specific tools
- Coordinate vendor and site qualification, selection, and onboarding
Execution & Oversight
- Oversee site activation, patient enrollment, and trial execution activities
- Monitor trial progress and site/vendor performance against timelines and deliverables
- Review and approve site-specific documents including budgets and monitoring reports
- Conduct regular data reviews and support query resolution and deviation tracking
- Manage inventory and logistics for study supplies and investigational products
- Maintain an inspection-ready Trial Master File (TMF)
Compliance, Risk & Communication
- Identify and mitigate risks through proactive trial-level risk assessments
- Ensure adherence to ICH/GCP, regulatory requirements, and internal SOPs
- Participate in audits and inspections, including site, vendor, and internal QA reviews
- Develop and deliver training to investigators, sites, and internal teams
- Provide timely updates to stakeholders on study status, risks, and mitigation strategies
Cross-Functional Collaboration
- Partner closely with internal stakeholders to align on trial design and execution
- Support Clinical Data Management, Medical Monitoring, and Regulatory teams as needed
- Collaborate with Finance to manage trial budgets and forecasting
Qualifications
Required:
- BS in Life Sciences or related field with 6+ years clinical operations experience (or MS with 4+ years)
- Prior sponsor-side clinical trial management experience
- Demonstrated proficiency in clinical trial oversight, including CRO and vendor management
- Strong command of ICH-GCP and regulatory requirements
- Advanced skills in Microsoft Office Suite and clinical systems (e.g., CTMS, eTMF)
- Excellent organizational, problem-solving, and interpersonal communication skills
Preferred:
- Experience with CAR-T or oncology trials
- Familiarity with clinical trial execution in a start-up or fast-paced environment
- Current or recent CTM title for at least 1 year
Caribou compensation and benefits include:
- Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
- Salary Range: $150,000 to $165,000 - 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 and floating 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.
Caribou is an equal opportunity employer and does not discriminate based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender (including gender identity and gender expression), sex (which includes pregnancy, childbirth, and breastfeeding), genetic information, taking or requesting statutorily protected leave, hair texture or type or any other basis protected by law. In addition, Caribou prohibits the harassment of any individual on any of the bases listed above or any other characteristics protected under federal, state, or local laws.
Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.
We do not accept unsolicited resumes or candidate submissions from staffing agencies. All agencies must have a valid written agreement with Caribou Biosciences, Inc. for service in place. Any resume or candidate submitted by a staffing agency without such an agreement in place will be considered unsolicited, and Caribou Biosciences, Inc. will not be obligated to pay any referral or placement fee.
