Clinical Scientist

Intellia Therapeutics

Intellia Therapeutics

Operations
Posted on Thursday, May 30, 2024

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 Scientist within the Clinical Development organization, you will report into the Medical Director. The Clinical Scientist works closely with the rest of the Research and Development Medical team, as well as the rest of the Development Organization (Clinical Operations, Data Management, Biostatistics, Regulatory Affairs and Drug Safety. The Clinical Scientist is responsible for contributing scientific insight and expertise to develop and implement clinical development plans, as well as clinical trial designs, study protocols and related documents (e.g. investigator brochure, ICF etc.) and communication of study results.

Key Responsibilities:

  • Working directly with the Study Medical Lead to implement activities supporting the program clinical development plan including:

    • plan and execute clinical trial(s)

    • develop data collection, review, and interpretation processes

    • present, review and interpret the full spectrum of study data for study operations, assessment of safety and efficacy and exploratory investigations

    • partner with Drug Safety Scientists and participate in safety review and communication

    • prepare internal (including DMC or steering committee) and external scientific presentations, research manuscripts and review articles, as required

    • provide scientific input, review, and edits to clinical study reports, Investigator Brochures, narratives, INDs, NDAs, briefing documents, annual reports, and other regulatory submissions. May be called to draft sections of these documents

    • partner with Clinical Operations and Data Management to ensure data consistency, quality, integrity, safety, and alignment with company values

  • Scientific literature searches to distill data into concise summaries

  • Organize and provide training assistance to departments/vendors (scientific/development improvements).

  • Serve as a liaison with internal/external scientific and medical experts to ensure protocol execution is consistent with intent. Coordinate and oversee medical or endpoint-specific training for study protocols.

  • Assist with planning of, and participate in, Investigator Meetings and Advisory/Scientific boards. Prepare and present material including clinical data in these venues as needed.

  • Prepare Data Monitoring Committee (DMC) and/or adjudication charters. Prepare deliverables and participate in periodic review meetings.

  • Provide scientific expertise to other departments and functions as needed

About You:

  • A BA/BS degree in the areas of life science. Advanced degree such as Masters, PharmD, RN or PhD preferred

    • 5+ years of relevant Clinical Research experience required

    • Study execution and data review experience are required

  • Experience with domestic and international clinical trials design and study data reporting.

  • Understanding of the clinical trial stages and key data needs for program progression.

  • Knowledge of the drug development process including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) requirements.

  • Ability to work independently and collaboratively with internal teams, CROs and other key stakeholders, as required, in a fast-paced, multi-disciplinary team environment.

  • Exemplary critical thinking, planning, organization, and time management skills including the ability to support and prioritize multiple projects.

  • Solid communication and presentation skills.

  • Proficient in the use of software relevant to above tasks including data visualization tools such as Spotfire®, R, and/or GraphPad Prism

Physical Requirements

  • Ability to sit or stand for multiple hours at a computer/lab bench.

  • Visual acuity for tasks such as: preparing and analyzing data and figures, and other lab and/or computer work

  • Manual dexterity for keyboarding

  • Ability to periodically travel both domestically and internationally

#LI-KO2

Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, are expected to follow all applicable federal, state, and local public health regulations and guidelines, and are strongly encouraged to follow all public health recommendations, including being vaccinated for COVID-19.

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.