Since its inception over a decade ago, CRISPR Therapeutics has 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 Therapeutics has established strategic partnerships with leading companies including Bayer and Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California, and business offices in London, 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/science and 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.
CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site.
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.
To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy
