Associate Director, Clinical Scientist
Company: CRISPR Therapeutics
Location: Boston
Posted on: October 4, 2024
Job Description:
Position SummaryReporting to the Executive Director of Clinical
Development, the Associate Director, Clinical Scientist will
provide scientific input to early-stage clinical development
programs. The Associate Director, Clinical Scientist will be
responsible for the review of patient data, they will give input on
clinical trial design, and will aid in preparation of data for
presentation to leadership, at conferences, and to safety oversight
committees.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,
investigators brochure, eCRFs, 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, statistics, safety, commercial, and regulatory
affairs) to ensure translation of the clinical protocol into
operational deliverables
- 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 datasetsMinimum Qualifications
- PhD, RN, or NP with 5+ years of significant experience as a
Clinical Scientist in a biopharmaceutical organization
- Prior experience as a Clinical Scientist in an industry
setting
- 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 investigatorsPreferred
Qualifications
- MD with 3-5+ years of biopharmaceutical experience
- Experience in genetic medicines
- Prior work on cardiovascular trials or cardiovascular clinical
experience
- Clinical cardiovascular experience
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Keywords: CRISPR Therapeutics, Lowell , Associate Director, Clinical Scientist, Executive , Boston, Massachusetts
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