Senior Clinical Scientist: Data & Imaging Leadership

Regulatory Jobs; West Lafayette (IN); On-site; USD 120,000 - 170,000; Full time

Job summary

Regulatory Jobs seeks a Clinical Scientist to provide scientific leadership for assigned clinical studies, design data strategies, and lead analysis and reporting of clinical and imaging data in collaboration with Regulatory Affairs, Engineering, and cross-functional teams.

You will author clinical data content for IDEs, PMAs, and other submissions, coordinate DSMB activities, and support publications and presentation plans while traveling up to 15% of the time.

Qualifications

• Bachelor’s degree is required; advanced degree preferred.
• 3+ years of clinical research experience with study design and data analysis.
• Familiarity with regulatory guidelines and submission documents.

Responsibilities

• Develop clinical data strategies and independently design assigned clinical studies with cross-functional teams.
• Lead analysis, interpretation, and reporting of clinical and imaging data to stakeholders.
• Author and own clinical data content within regulatory submissions (IDEs, PMAs, 510(k)s, CE marks); coordinate submission plans.
• Coordinate DSMB data summaries, patient summaries, and meeting attendance.

Skills

Clinical data analysis

Regulatory submissions knowledge

Cross-functional collaboration

Communication skills

GCP & ISO 14155 knowledge

AI/data concepts fluency

Education

Bachelor’s degree in Life Sciences, Engineering, or related field

Master’s or PhD preferred

Job description

Regulatory Jobs seeks a Clinical Scientist to provide scientific leadership for assigned clinical studies, design data strategies, and lead analysis and reporting of clinical and imaging data in collaboration with Regulatory Affairs, Engineering, and cross-functional teams.

You will author clinical data content for IDEs, PMAs, and other submissions, coordinate DSMB activities, and support publications and presentation plans while traveling up to 15% of the time.