Clinical Trial Manager II
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 wantall ofour 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:
The Clinical Trial Manager II is an integral part of the team for the Clinical and Development Operations organization, providing day-to-day operational oversight and/or coordination of all aspects of clinical study execution. In this role, you will be responsible for driving operational excellence, collaborating cross-functionally with Data Management and Biostatistics, Medical, Regulatory Affairs, Clinical Pharmacology, Clinical Supply and CMC, Drug Safety, Medical Writing, Translational Medicine, and Pharmacovigilance as well as other Global Development functions.
In this opportunity, your main responsibilities will include:
Supports and executes the day-to-day operational aspects of clinical studies from the protocol concept through the clinical study report in accordance with project goals and objectives, and in compliance with applicable GCP/ICH guidelines, regulations, SOPs, and other global regulatory requirements
Develops and manages comprehensive timelines and metrics
Participates in the evaluation, selection, and management of external vendors, including organizing and/or hosting study-specific meetings, measuring key performance indicators, and vendor management governance (as applicable)
Participates and has input in the development of clinical study synopsis and protocol in conjunction with the clinical development plan
Participates in the planning of quality assurance activities and coordinates the resolution of audit findings
May have management/oversight responsibilities for clinical vendors and their project deliverables
Participates in the selection, training, and evaluation of study personnel (contract and internal) to ensure operational efficiency
May serve as subject matter expert (SME) in one or more areas such as the development of SOPs, systems, tools, best in class standards for operational execution, etc.
~20% travel required
If you enjoy working in a fast-paced Biotech environment, have a combination of experience across studies, programs, and functional levels within Development Operations, then this could be just the job for you! If you have the qualifications listed below, we want to talk to you!
Bachelor’s Degree in science or a health-related field is required; an advanced degree is preferred
6+ years of industry experience, 1-2 years of direct clinical trial or vendor management experience in the biotech/pharmaceutical industry
Must have experience with all phases of global clinical trials; experience with early-phase development is a plus
Experience with life cycle management across multiple therapeutic areas or disease states/indications is desirable
Strong management skills, and the ability to effectively lead and collaborate with both internal and external stakeholders
Excellent written and oral communication skills
Demonstrated leadership, problem-solving, conflict resolution skills
Excellent knowledge of GCP, ICH, and FDA regulations and direct experience with health authority inspections
Ability to travel (~20%)
Meet your future team:
This role will report directly to the Director, Clinical Operations, and be a member of the greater Development Operations team. As our clinical program portfolio expands, we will continue to build out our Clinical Operations team. The Clinical Operations groups as well as the Development Operations team members bring an extensive range of experience and knowledge to the clinical development process. As a key member of this team, you will join a group of passionate individuals who enjoy working with one another.
While the team is currently working virtually, we intend to return to our Cambridge, MA office with some flexibility to work from home. Although in a virtual environment, the group and the Intellia organization have made it a priority to continue to foster a sense of community. This includes team all-hands meetings, virtual happy hours, game nights, and more! You can expect to join a hardworking, collaborative environment driven to bring innovative therapies to patients and their families.
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.