Clinical Director at Element Science
San Francisco, CA, US
Summary of Role
We are seeking a clinical director to join our growing medical technology company.
This individual will be responsible for:
Leading Clinical team and represent Clinical function on Element Science Executive Team
Developing clinical operations strategy to conduct multi-center IDE trial
Building clinical team to support US IDE trial
Be Element Science executive liaison to clinical sites, KOLs and Principal Investigators
Managing clinical protocols to enable clinical evaluations of our technology
Managing study timelines of multi-center trials
Performing clinical site evaluation to assess site suitability
Clinical site onboarding and initiation to use our technology
Clinical site staff training on study design, requirements, and device use
Ensuring site compliance with protocol, including patient identification and follow-up
Managing clinical site data collection and site monitoring
Collaborating to interpret and describe data generated from the clinical work
Communicating clinical results to R&D team
All aspects of clinical protocols (CIP, CRF, ICF)
Identification/activation of appropriate clinical sites, negotiation of site agreements
Day-to-day management of Element Science Clinical team
Execution of clinical study management according to GCP Guidelines
Management of data collection and monitoring per study plan
Preparation of clinical study reports
Experience conducting US medical device clinical trials preferably with IDE experience (10+ years experience)
Science or Engineering background required (M.S. or B.S)
Evidence of data analysis and presentation of clinical data to engineers and scientists
Appreciation for quality system, risk management, and medical product development processes
Cardiology experience preferred but not necessary

Interested? Send a short introduction and your resume.