Clinical Scientist

How you will Achieve More with Intellia:

As a Clinical Scientist within the Clinical Development organization, you will report into the Medical Lead on one or more programs.

The Clinical Scientist works closely with the Medical Leads as well as the rest of the Development Organization as part of the medical team assigned to one or more development programs. The Clinical Scientist contributes scientific insight and expertise to plan and execute studies of new potential medicines in human subjects. Specific deliverables for the medical team include clinical development plans, clinical trial designs, study protocols and related documents (e.g. investigator brochure, ICF etc.), and communications 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, Clinical Pharmacology, Pharmacovigilance, and Regulatory Affairs.

You will be responsible for:

• Working directly with the Medical Lead to implement clinical development and study strategies:
  • 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 Safety Scientists and participate in safety review and communication
  • prepare internal 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, including training of external study personnel
• 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.
  • 3 years of relevant Clinical Research experience required
  • Familiarity with study design and execution, data review, and data management practices required
• 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 is preferred.

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 team is led by our CMO, a physician and medical oncologist with over 25 years of experience in large pharma and biotech drug development. Other senior team members have 10 or years of similar experience, including many with prior direct experience in nucleic acid therapeutics and cell therapy. Your medical colleagues at Intellia are physicians/scientists who share responsibility across the five development-stage programs.

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.