Clinical Scientist/ Senior Clinical Scientist

CRISPR Therapeutics•South Boston, MA

12d•$125,000 - $170,000•Hybrid

About The Position

Reporting to the Director of Clinical Development, the Clinical Scientist/Senior Clinical Scientist will provide scientific input to early and later stage clinical development programs.

Requirements

Advanced scientific or clinical degree (eg PhD, PharmD, MPH, etc).
Clinical Scientist: 1-3 years/ Senior Clinical Scientist: 4-8+ years of previous experience in clinical or related research
Excellent oral and written communication skills and analytical skills
Ability to work collaboratively in a fast-paced, team-based matrix environment
Familiarity with 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

Nice To Haves

Experience in cellular therapies/CAR-T trials
Experience in Phase 1/Phase 2 clinical trials

Responsibilities

Contribute to the scientific development of individual clinical studies in alignment with the clinical development plan, including authoring and reviewing clinical documents (e.g., protocols, investigator brochures, CRFs, ICFs, CSRs)
Perform initial review of clinical trial data (safety and efficacy), including assessing for consistency and completeness and providing preliminary assessments and recommendations
Contribute to the oversight in collaboration with the clinical development lead during the conduct of the study
Assist in communicating a clear overview of trial results
Collaborate with internal stakeholders (clinical operations, data management, clinical pharmacology, statistics, safety, commercial, and regulatory affairs) to ensure translation of the clinical protocol into operational deliverables
Collaborate with external stakeholders (CROs, investigators and clinical coordinators) to clarify data submissions
Review and synthesize scientific literature and competitive intelligence to support study and program strategy
Develop scientific and protocol training presentations to support internal and external meetings; e.g., site qualification and initiation, investigator meetings, and training materials
Support preparation of scientific material for conference presentations or publications
Contribute to the authoring and revision of regulatory submissions
Perform analyses and generate scientific slide decks based on clinical, translational and other datasets