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.
Caribou Biosciences is seeking a Director of Clinical Operations to join our company. The candidate is an individual who enjoys a scientific, dynamic start-up environment. The Director of Clinical Operations will manage clinical operations, plan clinical trial execution with the expectation and vision to obtain the highest data quality in a manner compliant with quality standards, regulatory guidance and within budget. 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 director will work closely with biostatistics, data management and drug safety to ensure quality clinical operations execution.
- Provide leadership to the overall strategic planning and successful implementation of the Company’s clinical development program
- Plan clinical trials, resource, and oversee and execute program objectives and high-quality deliverables within established timelines and budgets
- Design and implement effective processes, including contingency plans, to execute multiple clinical trials in stages of development to meet company objectives
- Ensure operational excellence by applying high industry standards, policies, systems, and processes across all clinical trials. Ensure that documentation from investigators and clinical sites meet FDA/GCP/ICH requirements.
- Manage and oversee clinical operations for all study activities including the development of study protocols, informed consent forms, study plans and manuals, case report forms, EC/IRB submissions, charters, patient recruitment, clinical study monitoring, clinical compliance/SOPs, safety evaluations, preparation of statistical analysis plans and clinical study reports. Provide clinical operations support for data management and biostatistics as needed.
- Prepare and maintain current clinical operations SOPs
- Train and assist site coordinators, CRO, and serve as a resource to site coordinators and investigators, monitor and track progress, and respond to day-to-day matters
- Conduct site monitoring visits, meet with site coordinators, field clinical staff
- Oversee external vendors to provide high-quality deliverables efficiently within established timelines and budgets. Oversee and evaluate performance of CROs and vendors.
- Work collaboratively and communicate effectively with functional area colleagues within a project team environment and with external professionals as needed to support clinical programs and company goals
- Create monitoring plans, coordinate study reports, assist in developing sections for investigator brochures, clinical sections of regulatory documents
- Develop and implement resource management and trial metric tracking tools. Prepare and manage study budgets. Create and maintain regular status report of study progress and timelines.
- Lead identification, evaluation and management of clinical study risks and challenges
- Ensure Clinical Operations compliance with company policies and procedures, guidelines and codes of practice required by regulators or law
- Other duties as assigned
Position Requirements and Experience
- Bachelor’s degree or advanced degree in a scientific or health care discipline
- 7-10+ years of Clinical Operations, 3-4 years in a leadership role
- Experience executing clinical trials in oncology, immuno-oncology, cell therapy or hematologic oncology
- Experience successfully managing Phase I and registrational oncology clinical studies, including study start up through study closure
- Understanding of data management components of clinical trials
- Comprehensive knowledge of ICH, GCP guidelines, and applicable regulations and practices
- Effective in developing and maintaining productive internal and external relationships
- Experience effectively selecting and managing CROs and establishing governance bodies
- Proven leadership and team building skills, along with success in risk mitigation, problem recognition and solving and identification of best practices
- Flexibility to meet the needs of a growing, diverse and dynamic company
- Excellent organizational skills and an ability to prioritize effectively to meet timelines
- Ability to work independently and as part of a team
- Organizational aptitude with attention to detail; ability to analyze problems and develop solutions in collaboration with multiple functional groups
- Effective interpersonal skills, verbal and written communication
- Ability to travel (10-20% depending on project needs) and willingness to respond to business needs across U.S. time zones
- Advanced degree in scientific research, clinical pharmacology, or nursing
- 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 www.cariboubio.com. 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.