Caribou Biosciences

QA Engineer

• 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.

Director of Quality Assurance – Clinical

Manager

• Lead the development and execution of clinical biomarker plans aligned with Caribou’s clinical development strategy
• Familiarity with preparing, updating, and finalizing documentation for regulatory submissions such as biomarker-related sections in Clinical protocols, Investigator Brochures, Clinical Study Reports and other related clinical biomarker related documents
• Lead biomarker-related activities across all phases of clinical trials, ensuring alignment with study objectives, timelines, and budget
• Organize, analyze results, interpret emerging clinical biomarker data, and communicate effectively at research and cross-functional meetings and senior management
• Participate in program development teams and lead pertinent translational research working groups
• Oversee the discovery, validation, and qualification of biomarkers and methods to inform mechanism of action, response/resistance, safety as well as disease monitoring, and treatment response evaluation of Caribou’s allogeneic cell therapy drug products
• Liaise and support cross-functional translational research teams including computational biology, clinical teams and lab scientists for biomarker analysis, back-translation and exploration of translational strategies such as indication or patient selection

Senior Manager – Clinical Biomarkers

Medical Director

• Leading the direction, planning, execution of clinical trials and interpretation of clinical data
• Establishing scientific methods for design, implementation of clinical protocols, and ensuring trial subject safety
• Leading clinical trials, phases I - IV, for company products under development
• Building and managing the clinical research scientist team supporting clinical trials and overseeing CROs and other vendors
• Building reliable relationship with clinical investigators, discussing trial design, leading investigator’s meetings and advisory boards
• Monitoring safety and reporting adverse events
• Coordinating and developing information for reports submitted to the FDA and other health authorities and representing the Company at different forums
• Monitoring adherence to protocols and determining study completion
• Reviewing clinical data and leading/authoring reports and study related documents, such as IBs, study protocols, publications and regulatory filings including briefing documents, reports, and IND/BLA submissions
• Evaluating products for in/out licensing
• Participating in cross-functional teams, working in a highly matrixed team environment to advance preclinical programs to clinical evaluation
• Staying abreast on the clinical development and regulatory issues related to other competitive or relevant compounds in development and providing recommendations on changes needed to our strategy or clinical development plan as a result
• Provide medical review, assessment and interpretation of clinical data reported in clinical study reports to ensure that the data are correct and presented with the appropriate medical interpretation
• Adhere to both Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) aligned with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH)
• Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations, and laws

Research Analyst

• Support site start-up activities by collecting essential documents, coordinating with Legal on CTA development and tracking, and establishing structured roadmaps to keep sites on target for milestones and enrollment deadlines
• Identify and manage site-level review processes (administrative, scientific, IRB, IBC), determine sequencing vs. parallel reviews, and document review timelines to ensure timely approvals
• Conduct qualification, initiation, interim monitoring, and close-out visits, ensuring compliance with protocols, GCP/ICH, SOPs, and regulatory requirements
• Oversee site performance by addressing deviations, enrollment challenges, and inspection readiness, while maintaining consistent communication and updates with site staff and internal teams
• Track vendor deliverables and timelines, escalate issues, and coordinate resolution of site-level queries, study supplies, data entry, and related tasks
• Support vendor interactions by ensuring documentation is accurate, study systems are maintained, and site-facing needs are resolved in alignment with study timelines
• Collaborate with internal functions including Regulatory, Quality, Data Management, and Clinical Operations team members to drive study execution and maintain alignment across activities
• Participate in study meetings, prepare and track minutes and action items, and support responses to audits and inspections with Quality and Regulatory
• Maintain and review Trial Master File (TMF) documentation and study records to ensure inspection readiness and regulatory compliance
• Review clinical data listings, escalate discrepancies, and contribute to preparation of protocols, consent forms, and training materials, ensuring adherence to GCP, ICH, and company SOPs

Clinical Research Associate, CRA

Director

• Lead IP strategy development and implementation for Caribou Biosciences
• Manage active global docket, including independently drafting and prosecuting U.S. patent applications and provide prosecution strategy and instructions to foreign counsel
• Lead IP due diligence for in- and out-licensing opportunities and strategic alliances
• Conduct freedom-to-operate, infringement, and validity analyses
• Identify and assess IP risk and develop risk mitigation strategies in support of the Company’s product candidates
• Analyze new innovation disclosures and lead Patent Committee meetings
• Provide counseling to internal stakeholders on patent and related IP matters
• Advise on IP issues relating to clinical trials and regulatory approval
• Directly supervise Senior Paralegal, Intellectual Property, including managing workload, conducting performance evaluations, and supporting professional development
• Foster a collaborative and supportive team environment within the Legal Department
• Build effective relationships within the Company; provide in-depth, clear, and strategic patent and scientific expertise, education, guidance, and advice
• Maintain expertise in patent law, case law, and regulations of the U.S. Patent and Trademark Office and other foreign patent offices
• The position is based onsite at Caribou’s Berkeley, California facility, a minimum of 2 days per week is required, and is not suitable for a fully remote working arrangement

Director of Quality Assurance – Clinical

Senior Manager – Clinical Biomarkers

Medical Director

Clinical Research Associate, CRA

Director of Intellectual Property