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)
• 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, 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.

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.

Summary:

Responsible for leading in the development, implementation and maintenance of QA systems and activities supporting quality oversight towards GCP, GLP, and PV operations. The incumbent will assist in the development of quality systems to ensure clinical trials are conducted in accordance with appropriate regulations, guidelines, procedures, and protocols.

The incumbent is also responsible for developing specific internal procedures, training of staff, and hosting regulatory inspections. The position involves managing clinical quality operations and liaison of clinical quality related issues with Company’s functional areas. The candidate will perform audits of service providers, study sites, and internal processes.

The successful candidate must have the ability to execute QA tasks independently; effectively represent QA in a GCP, PV, and GLP focused team settings and manage quality related activities related to clinical vendors, investigator sites and regulatory agencies. In addition, the candidate must actively manage an appropriate level of inspection readiness of Company’s clinical stakeholders and act as a catalyst for continuous process improvement.

Responsibilities:

• Compliance Oversight: Ensure that all clinical trial activities comply with guidelines and international regulations (e.g., ICH-GCP and ICH-PV), and applicable laws.
• Documentation Review: Conduct thorough reviews of study-related documentation, including protocols, investigator brochures, informed consent forms, and CSRs, to verify compliance with GCP requirements.
• Provide Clinical Quality Assurance (GCP) strategic and technical leadership and Subject Matter Expertise (SME) to clinical study teams; Partner with the teams to effect appropriate and timely documentation of quality event management, including CAPA plans in support of product pipeline.
• Plan and oversee activities in support of regulatory submissions and inspections; Lead GCP Inspection Readiness efforts, ensure implementation and prepare internal and external teams for Pre-Approval Inspections (PAI).
• Implement, monitor, and promote best practices of all Quality Assurance Systems to ensure compliance with relevant FDA, EU and ROW regulations/directives/requirements and ICH guidelines.
• Quality Management System (QMS): Maintain and enhance Caribou’s QMS by implementing processes and procedures that ensure consistent adherence to GCP, GLP and PV standards throughout the clinical trial lifecycle.
• Develop and implement the appropriate suite of Standard Operating Procedures (SOPs), quality manuals, policies, and other related quality documents. Ensure that these systems are effectively communicated, understood, and followed by relevant stakeholders.
• Create and implement clinical quality risk management strategies to identify, assess, and mitigate risks associated with clinical development and operations. This involves conducting risk assessments, developing risk mitigation plans, and overseeing their implementation.
• Build training and approve curricula based on the key elements of the Quality System; Provide leadership and oversight for training programs related to pre-clinical, clinical and PV. Ensure that employees and relevant stakeholders receive appropriate training on quality standards, regulations, and procedures.
• Establish and monitor quality metrics and key performance indicators for the effectiveness of pre-clinical, clinical, and PV quality assurance activities. Prepare routine reports and presentations for senior/executive management review highlighting quality performance, trends, and areas for improvement. Assist with tracking compliance audit trends and present to management.
• Collaborate with cross-functional teams, including pre-clinical, clinical operations, regulatory affairs, pharmacovigilance, and other relevant departments, to ensure alignment and integration of quality assurance activities. Build and maintain effective relationships with internal and external stakeholders, including regulatory agencies and service providers.
• Perform internal and external audits to ensure stakeholder system compliance with existing policies and procedures, and requirements, standards, and guidelines.
• Lead and/or manage additional Quality Assurance (GxP) initiatives or programs as business needs evolve.

Qualifications:

• Undergraduate or graduate degree(s) in Biological Sciences, Chemistry, or related Science discipline with at least 15 years of experience in clinical quality assurance (GCP, GLP and PV) in cell & gene therapy/biotechnology and/or pharmaceutical industry. Experience working in biologics is strongly preferred.
• Subject Matter Expert (SME) working knowledge on current interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines and other local government regulatory requirements governing clinical research.
• Proven track record in developing and implementing quality systems and processes in a clinical setting.
• Expertise in creating and executing audit plans outlining all service providers (vendor) audits, clinical investigator site audits, CSV audits and process audits.
• Advanced knowledge of Quality Assurance principles, concepts, industry practices, and standards.
• Prior GLP experience with quality oversight and auditing studies/vendors (preferred).
• Excellent verbal and written communication skills, ability to lead cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality and being an advocate for quality and regulatory compliance.
• The position requires a highly diplomatic, and tactful individual with excellent critical reasoning skills.
• Conscientiously detail-oriented and organized, impeccable attention to data review.
• Ability to deal with ambiguity and use expertise and skills to contribute to the development of company objectives and principles, and to achieve goals in creative and effective ways.
• Must be flexible and able to multi-task, prioritize, meet deadlines in a fast-paced environment, and be adaptable to setbacks.
• Detail-oriented mindset with a proactive approach to problem-solving and decision-making.
• Certification in quality assurance (e.g., Certified Quality Auditor) and/or GCP (e.g., Certified Clinical Research Professional) is desirable.
• Ability to travel up to 25-30% based on business needs.

Caribou compensation and benefits include:

• Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
• Salary Range: $220,000 to $235,000- 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.

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.

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 delivers unmatched precision, enabling us to develop cell therapies that are designed to be more effective against a range of serious conditions. We believe the future of cell therapy is off-the-shelf, and we are advancing our pipeline of allogeneic, or "off-the-shelf," cell therapies from our CAR-T cell therapy platform as readily available treatments for patients with hematologic malignancies and autoimmune diseases.

At Caribou Biosciences, we foster a culture where innovative thinking thrives, and diverse perspectives are valued. We are committed to creating an environment where team members are personally engaged, their ideas are taken seriously, and their contributions are recognized. Whether you're working from our headquarters in Berkeley, California, or remotely, you'll be part of a dynamic and supportive community.

Express Your Interest in Future Roles

Are you passionate about the potential of genome-editing technologies and eager to contribute to groundbreaking therapies? If you're interested in joining Caribou Biosciences but don't see a current opening that matches your skills, we'd love to hear from you! Submit your resume and share your career objectives with us. While we may not have an immediate match for every general interest application, we'll keep your information on file and may reach out if a suitable opportunity arises.

To stay up-to-date with our open roles, we encourage you to regularly check our careers page and apply directly to positions that align with your background and experience.

Thank you for your interest in becoming a part of the Caribou herd. We look forward to potentially welcoming you to our team!