Director/Senior Director of Clinical Operations

180 - Clinical · Berkeley, California
Department 180 - Clinical
Employment Type Full-Time
Minimum Experience Experienced

Caribou Biosciences, Inc. is a leading clinical-stage CRISPR genome engineering biotechnology company located in Berkeley, CA. Caribou's tools and technologies provide transformative capabilities to therapeutic development and the company is advancing an internal pipeline of genome-edited cell therapies for various oncology indications. The eight-year-old company has developed a best-in-class CRISPR genome engineering technology platform and has a leading intellectual property position. At Caribou, every employee is valued for their unique perspective, background, and diversity. Every person on the Caribou team contributes to problem solving and innovation. The Company’s vision is to advance agile genome editing innovations for the benefit of our communities.

The Company is seeking an experienced Director/Senior Director of Clinical Operations to help establish Caribou as a clinical stage company. The ideal candidate will direct and manage clinical CRO relationships and interact closely with senior management, regulatory, process development, functional group leaders, scientists, and research associates to implement clinical trials for multiple pre-clinical programs. This hands-on role will include documenting and reporting the clinical development program, negotiating contracts with CROs, study sites, clinical trial vendors as well as managing the recruitment, execution, and completion of clinical trials.   The candidate must travel for site training, monitoring, etc. for approximately 30% of their working hours. 

Responsibilities will include:

  • Assist in developing study protocols, informed consents, study manuals, case report forms, clinical reports, and clinical SOPs
  • Train and assist site coordinators, investigators, and CRO, and serve as a resource to site coordinators and investigators, monitor and track progress, and respond to day-to-day issues
  • Perform site monitoring visits and interface with site coordinators, field clinical staff, and CROs
  • Provide leadership to the overall strategic planning and successful implementation of the Company’s clinical development program
  • Manage timelines for achieving clinical milestones
  • Ensure that documentation from investigators and investigational sites meets FDA/GCP/ICH requirements
  • Review study records to ensure regulatory and study requirements meet expectations
  • Analyze data, interpret research information, create detailed documentation, develop tracking tools, and organize data for accurate clinical reports
  • Create monitoring plans, coordinate study reports, and assist in developing sections for Investigator Brochures and clinical sections of other regulatory documents
  • Assist in identification and hiring of CROs and other third-party vendors.  Oversee performance of CRO and third-party vendors including co-monitoring to ensure compliance with study protocols
  • Prepare, negotiate, and manage study budget. Perform initial review of CRO and vendor invoices
  • Develop and implement enrollment strategies
  • Compile and maintain regular status reports of study progress and study specific timelines 

Candidate must possess:

  • Bachelor’s degree or higher in a scientific or health care discipline 
  • At least 5 years in the role of Clinical Research Manager or Director of Clinical Operations
  • Minimum of 10 years in clinical operations including successful management of CROs and study sites from study start-up through study maintenance and close out, with demonstrated understanding of the data management components needed in a trial, enrollment objectives, management, and strategies
  • Extensive experience in the preparation, monitoring, and execution of clinical studies
  • Demonstrated ability to motivate clinical site personnel to achieve clinical operational milestones
  • Excellent understanding and application of Good Clinical Practices (GCP) and ICH guidelines. Compliance with safety standards and privacy and confidentiality.
  • Demonstrated medical/therapeutic knowledge and medical terminology
  • Excellent verbal/written communication skills and organizational aptitude along with strong attention to detail
  • Ability to work both independently and collaboratively with cross-functional teams and external organizations
  • Critical thinking to analyze problems which may require multiple factors and approaches

Additional pluses:

  • Practical knowledge of hospital or clinic operations
  • Advanced degree in scientific research, medicine, or nursing
  • Experience in oncology and/or cell-based therapies
  • Project management skills 

Caribou Biosciences, Inc. is a dynamic start-up biotechnology company, and the successful candidate should have a passion for science and a desire to work in a collaborative environment. Caribou promotes a culture in which employees are respected and valued for hard work, innovation, personal initiative, and teamwork.


Caribou offers a comprehensive compensation package, as well as generous paid time off in addition to Company-observed holidays. The Company provides medical, dental, and vision insurance, along with a 401(k) retirement savings plan which includes matching employer contributions.


For more information, please visit Caribou is on Twitter. Follow the Company @CaribouBio.


Caribou is an equal opportunity employer and does not discriminate on the basis of 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.


Direct applicants only. No agencies please.


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  • Location
    Berkeley, California
  • Department
    180 - Clinical
  • Employment Type
  • Minimum Experience