Director, Clinical Scientist

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.   

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 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 Senior Director. 

The Clinical Scientist works closely with the Clinical Development Physicians, as well as the rest of the Development Organization and 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 The Clinical Scientist is to work collaboratively with other study team members including but not limited to Clinical Operations, Data Management, Biostatistics, Safety, and Regulatory Affairs.

You will be responsible for:

• Working directly with the Program Medical Lead and will implement clinical development and study strategies to:
  • Plan and execute clinical trial activities
  • 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 Clinical 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 and to distill data into concise analysis / reports
• 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

About You

You are a subject matter expert (SME) and key clinical development team member who would embrace the challenge to create an innovative approach to CRISPR/Cas9 gene-editing and disease-specific clinical data review and interpretation across our diverse development portfolio.

• A BA/BS degree in the areas of life science.  Masters, PharmD, or PhD preferred
  • 10+ years of relevant Clinical Research experience required
  • Study design and execution, data review and data management 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

Meet your future team:

The Clinical Development Team at Intellia is here because we believe genome editing has incredible potential to treat and cure life-threatening and fatal diseases, and we believe the Intellia has the right people, strategy, and culture to do it well.  The experienced team is led by our Vice President, Development; a Nephrologist with over 10 years’ experience in biotech new product development.  Other team members have 5-15 years of similar new product development experience in a biotech-outsourced operational model setting. 

Covid-19 Vaccination Policy: Effective Monday, January 3, 2022, all Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. 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.