At CRISPR Therapeutics, we are focused on developing transformative gene-based medicines for serious human diseases.
We are rapidly translating our specific, efficient and versatile CRISPR/Cas9 gene-editing platform into therapies to treat hemoglobinopathies, cancer, diabetes and other diseases
Our multi-disciplinary team of world-class researchers and drug developers works every day to translate our CRISPR/Cas9 technology into breakthrough human therapeutics. Our lead program targeting the blood diseases -thalassemia and sickle cell disease has entered clinical testing, and our immuno-oncology programs, focused on CRISPR/Cas9-edited allogeneic CAR-T cell therapies, have the potential to deliver a new generation of cancer therapies to patients.
Reporting to the Director of Clinical Operations, this individual will have primary responsibility for trial management within oncology indications. The successful hire will adhere to best practices ensuring rigor and high-quality execution of clinical trials from FIH through commercial marketing authorization. This person will manage cross-functional relationships with internal and external stakeholders and be the clinical operations representative to the respective program clinical sub-team. This individual will be hands on with trial sites fostering relationship development with KOLs. This is a high visibility position with great impact potential.
Responsible for managing CROs/vendors for assigned trials ensuring adherence to defined scope of work and budget
Identify issues and implement solutions to ensure timelines are maintained
Develop and maintain tracking tools for clinical trials including study and monitoring visits, sample tracking, data entry and action item progress
Assist with the drafting of protocols, informed consent forms, study operations guidelines and other study plans
Develop trial specific training tools for site utilization
Oversee maintenance of the eTMF
Work with CRISPR financial management to reconcile monthly actual and forecast budgets
Monitor and/or co-monitor clinical trial sites
Plan and coordinate advisory boards, investigator meetings and CRA trainings
Work collaboratively with supply chain to ensure seamless collection/manufacture/shipment of cells
Develop project-specific procedures and processes
Recommend and follow up on corrective actions
The candidate must maintain a high standard of professionalism, and confidentiality in this role and must be able to problem solve, communicate effectively, and trouble-shoot creatively
BS/BA/BSN health/science related field preferred
Minimum 3-5 years relevant industry experience including at least 2 years of trial management experience.
Excellent communication, writing and presentation skills
Demonstrated ability to work independently as well as in a team environment and seek resources as necessary.
Ability to assess complex issues and propose viable solutions
Demonstrated ability to lead and organize team meetings
Ability to foster effective relationships with vendors, investigators and colleagues
Ability to contribute technical expertise to the various aspects of the clinical trial process.
Knowledge of industry standards as applied to ICH guidelines, GCPs and the CFR
Proficiency in study monitoring activities
Knowledge of the infrastructure and operational characteristics of CROs and centralized services.
Demonstrated effective time management skills
Must be willing to travel domestically and internationally up to 15-20%
MS or advanced degree
5 or more years in a Clinical Operations Management role
Global trial management experience
Prior Clinical Monitoring and/or CRO experience
Knowledge of First in Human trial management
Experience with oncology and/or transplant
Experience with cellular therapy trial management
CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
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