Principal Clinical Scientist
New
J
JobgetherDiagnostics, Medical Devices
Based in United StatesFull-TimePrincipal
Salary$120,000–$165,000 USD
Apply NowOpens the employer's application page
Job Details
- Experience
- Bachelor’s degree with 9+ years, Master’s degree with 12+ years, or Doctoral degree with 4+ years of relevant clinical research experience
- Required Skills
- Data Analysis
Requirements
- Bachelor’s degree in Life Sciences, Healthcare, or a related discipline with 9+ years of relevant clinical research experience.
- Master’s degree with 12+ years of relevant experience, or Doctoral degree with 4+ years of relevant experience.
- Strong knowledge of clinical study design and methodology within the diagnostics, medical device, or pharmaceutical industries.
- Experience supporting products intended for US and European markets.
- Ability to critically evaluate scientific and clinical trial data and oversee study protocols and reports.
- Strong problem-solving skills with the ability to address complex clinical and scientific challenges.
- Excellent written and verbal communication skills.
- In vitro diagnostic (IVD) technology experience highly preferred (e.g., Clinical Chemistry, Immunoassays, Hematology, Urinalysis, Flow Cytometry, or Biomarkers).
- Professional certification in Clinical Research (such as SoCRA or ACRP) is preferred.
Responsibilities
- Develop and execute clinical study strategies supporting global regulatory submissions, including FDA and CE-IVDR pathways.
- Design clinical studies and evidence plans across multiple diagnostic technologies and product portfolios.
- Act as a scientific and clinical partner to regulatory agencies, key opinion leaders, external study sites, and internal teams.
- Create and review clinical documentation, including study protocols, reports, technical documentation, and scientific publications.
- Partner with R&D, Regulatory Affairs, Medical Affairs, Quality, and Commercial teams to align clinical programs with business and market access objectives.
- Provide scientific oversight throughout clinical study execution, ensuring compliance with applicable standards and regulations.
- Analyze and interpret clinical and scientific data to support decision-making and product development strategies.
- Identify and resolve complex clinical trial challenges through strong scientific judgment and problem-solving skills.
View Full Description & ApplyYou'll be redirected to the employer's site
