Why Join Intellia?
Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.
Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done.
We want all of our people to go beyond what is possible. We aren’t constrained by typical end rails, and we aren’t out to just “treat” people. We’re all in this for something more. We’re driven to cure and motivated for change. Just imagine the possibilities of what we can do together.
How you will Achieve More with Intellia:
As a Clinical Trial Manager I, you will join our Clinical Operations group, where we provide oversight for all phases of clinical trial activities (feasibility, start-up, maintenance and close-out).
Other main responsibilities include:
Support and lead project study management activities, vendor management assignments, and management of operational activities related to study programs.
Support infrastructure activities, administrative activities, and management activities for clinical programs / studies / Clinical Operations department.
Assist and may lead in development of internal and study related documents, as applicable (i.e. Informed Consent Forms, study reference manuals, newsletters, etc)
May lead smaller Phase Ia, Ib, or II clinical trials or play a supporting role in more complex phase I, II or III clinical studies with mentorship and oversight until competence for tasks is established.
Supports the development of Clinical systems (e.g. EDC, CTMS, eTMF, IRT, etc.). Integral user of these systems.
Facilitation and oversight of quality processes and documents for assigned project(s) including working with cross functional team members (e.g. Medical, Data Management, Regulatory, Quality Assurance, Drug Supply, etc)
Create content for presentations and materials for functional, cross-functional and leadership project meetings
Identification of potential deliverable or timeline challenges or bottlenecks; presents suggested prioritization or options
Creates, maintains, updates and reconciles spreadsheets and study trackers to support various projects such as: (but not limited to): study metrics, financial trackers, review and finalization of study team minutes, trial master file (TMF) tracking, etc.
Solicits cross functional input to create, maintain, update and/or reconcile project and timeline tracking software or spreadsheets and various summary reports to inform various project team stakeholders
Our ideal candidate has a BA/BS degree with 6 years of professional experience working in a clinical research environment (clinical site, CRO or biotech/pharma company) or demonstration of equivalent capability in a Clinical Operations role. If you describe yourself as a team player with excellent attitude, strong interpersonal skills and excitement to cultivate strong cross-functional relationships, we encourage you to apply! Other desired skills include:
High level of energy, passion for job, creative problem solver, proactive and highly productive
Strong knowledge of FDA regulations, ICH guidelines and Good Clinical Practice (GCP)
Strong computer skills working with Microsoft office programs (Word, Excel, PowerPoint, Outlook and Microsoft Project)
Outstanding organizational skills
Excellent written and oral communication skills (timely, clear)
Meet your future team:
The Clinical Operations team is responsible for conducting clinical trials and the many aspects involved in doing so in order to generate the clinical data required to bring a drug candidate to market.
Your future hiring manager is the Associate Director/Director, Clinical Operations, the successful candidate will be responsible for supporting the organization to develop and implement clinical trials across the portfolio.
The team is currently working mostly remotely across the United States. The candidate must be located within the Unites States, or open to relocating. While much of the day-to-day operations require collaborating in a virtual workplace, our team is focused on building not just technical expertise but fostering an environment for growth in a career in Clinical Operations. If you join our team, you can expect to join fast, fun, exciting and collaborative environment. We look forward to fostering your skills, learning from your experiences, and building a larger team together.
Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. Requests for exemption for medical or sincerely held religious beliefs will be considered.
EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.