Caribou Biosciences

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

Senior Manager – Clinical Biomarkers

Medical Director

Clinical Research Associate, CRA

Director of Intellectual Property