[Hiring] Director of Clinical Operations @Caribou Biosciences

Role Description

The Director of Clinical Operations will serve as the cross-functional study team lead for a high-priority hematology program, with overall accountability for the strategic planning and execution of all operational activities. This role will provide leadership and oversight of CROs and vendors, including governance, to ensure delivery against timelines, quality, and budget expectations.

The individual will work collaboratively with internal functional leads (Clinical Development, Regulatory, Translational, Data Management, and Biostatistics) to drive integrated study execution, while providing strategic direction and ensuring alignment across stakeholders. They will demonstrate strong matrix leadership, proactive risk identification and mitigation, and effective problem-solving to achieve key program milestones.

This role requires the ability to balance budget, timelines, and evolving trial needs, maintaining transparency and a solution-oriented approach to decision-making. A strong focus on data quality, inspection readiness, and overall trial execution excellence is essential.

This candidate can be remotely based, and ideally attends relevant congresses, conducts on-site visits and joins the greater team at Caribou headquarters (Berkeley, CA) as able.

Responsibilities

• Provide strategic operational leadership and oversight for a key clinical program, ensuring alignment with clinical development objectives and corporate goals.
• Oversee CROs and vendors, leading governance and partnering closely to ensure accountability for delivery of operational activities, timelines, quality, and budget, and driving proactive risk management and mitigation across the study.
• Lead study-specific and cross-functional meetings, driving clear decisions, accountability, and timely issue resolution.
• Collaborate cross-functionally (Clinical, Regulatory, Translational, Data Management, Biostatistics) to ensure integrated and efficient study execution.
• Oversee study progress and performance using key metrics (e.g., enrollment, eligibility, data quality, primary endpoints), ensuring transparent communication and a solution-oriented approach.
• Proactively identify, assess, and manage study and program-level risks, including mitigation planning and escalation of critical issues.
• Ensure data quality, integrity, and completeness to support analyses, regulatory submissions, and program decision-making.
• Establish and oversee vendor governance, including performance management, SOW/budget review, and financial tracking (forecasts, accruals).
• Ensure inspection readiness, including TMF quality, audit preparedness, and compliance with GCP and internal SOPs.
• Build and maintain strong relationships with investigators, study staff, and external partners, and represent Clinical Operations in internal governance and external interactions.

Qualifications

• Bachelor’s Degree is required, in a science or a health-related field.
• A minimum of 10 years of global clinical trial management experience within the pharmaceutical or biotechnology industry.
• Early phase oncology focus is key, preferably within the hematology space.
• In-depth understanding and experience across clinical operations with a track record of success in CRO and vendor delivery oversight.
• Being a key contributor to study planning, execution, data cleaning, database locking, study report generation and regulatory inspection.
• Experience with developing protocols, SOPs, Clinical Study Reports, INDs, NDAs, as well as other clinical, regulatory, and safety documents preferred.
• Ability to lead cross functional study teams in a dynamic, evolving organization.
• Excellent communication and interpersonal skills, with the ability to lead and motivate teams and collaborate effectively across functions (internally and externally).
• Ability to travel up to 20% based on business needs.

Nice-to-Haves

• Prior experience in the CAR-T space, with a specific focus in hematology.
• An emphasis on inspection readiness for Clinical Operations.
• Ease and confidence in being Investigator and site-facing.

Benefits

• Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees.
• Salary Range: $240,000-$255,000; 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.