Principal Clinical Scientist

About This Role

The Principal Clinical Scientist designs and executes clinical trials and studies for Abbott's Vascular Division, supporting regulatory submissions to the FDA and strategic business objectives. This role involves scientific leadership, document generation, data analysis, and publication strategy within a quality system environment.

Responsibilities

• Design clinical trials and studies in collaboration with internal and external stakeholders to support device premarket approvals and strategic business needs.
• Provide scientific and technical direction and feedback, serving as Clinical Science lead on study teams.
• Lead the generation of study-related documents including clinical study protocols, case report forms, and clinical study reports.
• Generate documents to support regulatory submissions and respond to regulatory authority questions.
• Critically analyze data and present findings to internal and external groups.
• Develop and lead the execution of scientific podium and publication strategies.
• Review and critically assess statistical analysis plans.
• Attend, present at, and lead meetings with FDA and other regulatory bodies.
• Mentor junior team members.

Requirements

• Minimum 8 years of related work experience
• Complete understanding of specified functional area
• Comprehensive knowledge of a particular technological field
• In-depth knowledge of business unit functions and cross group dependencies/relationships
• Ability to work in a quality system environment

Qualifications

• Bachelor’s Degree in related field or an equivalent combination of education and work experience.
• Minimum 8 years of related work experience with a complete understanding of specified functional area and comprehensive knowledge of a particular technological field.

Nice to Have

• Experience in the medical device industry
• Experience with clinical trials
• Experience in vascular/cardiovascular fields

Benefits