Please enable JS

Clinical Scientist

If interested and qualified, please include Requisition # 2017-241 in the subject line when emailing resume to: careers@crisprtx.com.

For more information on CRISPR Therapeutics, please click here.

Position Summary

Reporting to the Senior Medical Director within Clinical Development.  The Clinical Scientist will provide scientific input to early and late stage clinical development programs. This role will work on cross-functional study teams for the design and execution of clinical trials, as well as data interpretation and communication. This individual will report directly into the Executive Vice President and Head of Research and Development and will interface directly with other functions including Clinical Operations, Regulatory Affairs, Research, Clinical Pharmacology, Data Management and Pharmacovigilance.

Responsibilities

  • Contribute to the scientific development of individual clinical studies in alignment with the approved clinical development plan, including authoring and reviewing clinical documents (e.g., protocols, eCRFs, ICFs, CSRs)
  • Responsible for analytical support of clinical trial data (safety and efficacy), including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations
  • Contribute to the clinical oversight and medical review of clinical trial data in collaboration with the Medical Monitor during the conduct of the study
  • Analyze and synthesize information to assess issues relating to protocol conduct and/or individual subject safety Assist in communicating a clear overview of trial results
  • Collaborate with internal stakeholders (clinical operations, data management, statistics, safety, commercial, and regulatory affairs) to ensure translation of the clinical protocol into operational deliverables
  • Prepare literature reviews as needed
  • Develop scientific and protocol training presentations to support internal and external meetings; e.g., Advisory Board meetings, investigator meetings, and training materials
  • Support preparation of scientific material for conference presentations or publications
  • Contribute to the scientific content of program level deliverables; e.g. Investigator Brochure
  • Contribute to the authoring and revision of regulatory submissions
  • Generate scientific slide decks based on clinical trials
  • Contribute to multidisciplinary working groups to support continuous process improvement as requested

Minimum Qualifications

  • Advanced degree in a scientific discipline, RN, Pharm D or PhD
  • 5+ years' previous experience in clinical research
  • Excellent oral and written communication skills and solid MS PowerPoint, MS Word, MS Excel, and analytical skills
  • Ability to work collaboratively in a fast-paced, team-based matrix environment
  • A thorough understanding of ICH, GCP, and relevant regulatory requirements, and strong analytical and strategic thinking skills, experience with interacting with medical monitors, development operations (preclinical, clinical operations, regulatory affairs, Quality Assurance) and clinical investigators

Preferred Qualifications

  • Experience with global studies
  • Experience in clinical drug development including biologics or cellular therapies
  • Experience with transplant, Phase I first-in-human trials and regulatory submissions

Competencies

  • Adaptability/Flexibility - The ability to adapt to working effectively within a variety of situations; adapts enthusiastically to organizational change and to changes in job demands.
  • Communication and Teamwork - The ability to effectively express ideas in written and oral context. The ability to work co-operatively with others; the genuine desire to be a part of a team and contribute to organizational and team goals.
  • Effective Planning - Embedding discipline and thoroughness in our approaches.
  • Results Oriented - Drives issues to closure and gets the job done.

If interested and qualified, please include Requisition # 2017-241 in the subject line when emailing resume to: careers@crisprtx.com.

For more information on CRISPR Therapeutics, please click here.