Company Overview

Since its inception over a decade ago,CRISPR Therapeuticshas transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts,CRISPR Therapeuticshas established strategic partnerships with leading companies includingBayerand Vertex Pharmaceuticals.CRISPR Therapeutics AGis headquartered inZug, Switzerland, with its wholly-ownedU.S.subsidiary,CRISPR Therapeutics, Inc., and R&D operations based inBoston, MassachusettsandSan Francisco, California, and business offices inLondon, United Kingdom.

Position Summary

Reporting to the Associate Director of Clinical Operations, this individual will have primary responsibility for trial management within in vivo, regenerative medicine, or 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.

Responsibilities

• 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, but not limited to, site start-up status, enrollment, study and monitoring visits, sample tracking, data entry and review and action items
• Assist with the drafting of protocols, informed consent forms, study operations guidelines and other study plans
• Oversee vendors and actively participate in all UATs for vendor systems, including IRT, EDC, Central Labs, etc
• 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, if needed
• Plan, coordinate and participate as needed in advisory boards, investigator meetings and CRA trainings
• Work collaboratively with supply chain to ensure seamless delivery of drug product to clinical sites
• Develop project-specific procedures and processes
• Develop and maintain study storyboards
• Recommend and follow up on corrective actions to ensure quick resolution of deviations or quality issues
• 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

Minimum Qualifications

• BS/BA/BSN – health/scienceand 6 years of professional experience working in a clinical research environment (clinical site, Clinical Research Organization, or biotech/pharma company), including 2 years of Clinical 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%

Preferred Qualifications

• MS or advanced degree
• 5 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
• Adaptability/Flexibility – The ability to adapt to working effectively within a variety of situations; adapts enthusiastically to organizational change and to changes in job demands
• Communication and Teamwork – The ability to effectively express ideas in written and oral context. The ability to work co-operatively with others; the genuine desire to be a part of a team and contribute to organizational and team goals.
• Effective Planning - Embedding discipline and thoroughness in our approaches.
• Perseverance – Pursues tasks with energy, drive and initiative, even in the face of adversity.
• Problem Solving – The ability to understand a situation, task or problem by breaking it down into smaller pieces using a systematic approach and to identify patterns and connections between situations that are not obviously related.
• Relationship Building – Builds and maintains productive working relationships across a diverse spectrum of people.

Competencies

• Collaborative – Openness, One Team
• Undaunted – Fearless, Can-do attitude
• Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
• Entrepreneurial Spirit – Proactive. Ownership mindset.