Director of Clinical Operations

Caribou Biosciences; Berkeley (CA); Hybrid; USD 240,000 - 255,000; Full time

Benefits offered by this job

Competitive salary

Bonus and equity participation

Generous paid vacation

Excellent medical, dental, and vision insurance

401(k) retirement savings plan with employer matching

Employee stock purchase plan

Job summary

Caribou Biosciences in Berkeley is seeking a Director of Clinical Operations to lead strategic oversight for key hematology clinical programs. This role demands a minimum of 10 years' experience in global clinical trial management within the pharmaceutical or biotechnology sectors, emphasizing early phase oncology and hematology. The position involves managing CROs and vendors, ensuring operational excellence. Flexible work arrangements are available, with potential travel up to 20%. Comprehensive compensation and benefits including a salary range of $240,000-$255,000, medical benefits, and 401(k) matching are provided.

Qualifications

• Minimum of 10 years of clinical trial management experience in pharmaceuticals or biotechnology.
• In-depth understanding of clinical operations and vendor oversight.
• Ability to travel up to 20% based on business needs.

Responsibilities

• Lead operational planning and execution of a hematology program.
• Oversee CROs and vendors, ensuring accountability for timelines and quality.
• Collaborate cross-functionally for integrated study execution.

Skills

Global clinical trial management experience

Excellent communication skills

Leadership and motivation

Cross-functional collaboration

Education

Bachelor’s Degree in science or a health-related field

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 and autoimmune diseases.

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.

About the Role

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

Requirements

• 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

Caribou compensation and benefits include:

• 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)

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, 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.