[Remote] Director of Clinical Operations

Note: The job is a remote job and is open to candidates in USA. Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. The Director of Clinical Operations will lead the cross-functional study team for a high-priority hematology program, ensuring strategic planning and execution of all operational activities while overseeing CROs and vendors to meet timelines, quality, and budget expectations.ResponsibilitiesProvide strategic operational leadership and oversight for a key clinical program, ensuring alignment with clinical development objectives and corporate goalsOversee 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 studyLead study-specific and cross-functional meetings, driving clear decisions, accountability, and timely issue resolutionCollaborate cross-functionally (Clinical, Regulatory, Translational, Data Management, Biostatistics) to ensure integrated and efficient study executionOversee study progress and performance using key metrics (e.g., enrollment, eligibility, data quality, primary endpoints), ensuring transparent communication and a solution-oriented approachProactively identify, assess, and manage study and program-level risks, including mitigation planning and escalation of critical issuesEnsure data quality, integrity, and completeness to support analyses, regulatory submissions, and program decision-makingEstablish 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 SOPsBuild and maintain strong relationships with investigators, study staff, and external partners, and represent Clinical Operations in internal governance and external interactionsSkillsBachelor's Degree is required, in a science or a health-related fieldA minimum of 10 years of global clinical trial management experience within the pharmaceutical or biotechnology industryEarly phase oncology focus is key, preferably within the hematology spaceIn-depth understanding and experience across clinical operations with a track record of success in CRO and vendor delivery oversightBeing a key contributor to study planning, execution, data cleaning, database locking, study report generation and regulatory inspectionExperience with developing protocols, SOPs, Clinical Study Reports, INDs, NDAs, as well as other clinical, regulatory, and safety documents preferredAbility to lead cross functional study teams in a dynamic, evolving organizationExcellent 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 needsPrior experience in the CAR-T space, with a specific focus in hematologyAn emphasis on inspection readiness for Clinical OperationsEase and confidence in being Investigator and site-facingBenefitsComprehensive compensation package, which includes competitive salary, bonus, and equity for all employeesGenerous paid vacation time, in addition to company-observed holidaysExcellent medical, dental, and vision insurance401(k) retirement savings plan, which includes matching employer contributionsEmployee stock purchase plan (ESPP)Tuition reimbursement programCompany OverviewCaribou Biosciences is a biotechnology company that develops CRISPR technologies and allogenic cell therapies for oncology. It was founded in 2011, and is headquartered in Berkeley, California, USA, with a workforce of 51-200 employees. Its website is http://www.cariboubio.com.