The Principal Scientist will own operational readiness and standards alignment for Standard Exchange of Nonclinical Data (SEND) deliverables supporting regulatory submissions
Job Summary
The Principal Scientist will own operational readiness and standards alignment for Standard Exchange of Nonclinical Data (SEND) deliverables supporting regulatory submissions.
You will be responsible for managing end-to-end nonclinical SEND submission package readiness, including study file management, QC, and final package assembly.
This role requires collaboration with internal and external partners to ensure high-quality packages through validation, QC, controlled terminology governance, and continuous process improvement.
Matching Summary
The Principal Scientist will own operational readiness and standards alignment for Standard Exchange of Nonclinical Data (SEND) deliverables supporting regulatory submissions.
Salary
Base: $117,000.00 - $201,250.00; Bonus/Equity: Eligible for annual performance bonus; Benefits: Medical, dental, vision, life insurance, disability, retirement plan, savings plan, paid time off
Skills & Requirements
Must-have
SEND subject matter expert
SEND deliverables readiness
controlled terminology governance
nonclinical data standardization
regulatory submission support
Nice-to-have
AI and Machine Learning initiatives
external standards forums participation
CRO SEND-ready data integration
global matrix organization leadership
Key Requirements
Bachelor's degree in Toxicology, Pharmacology, Biology, or related science
6+ years of relevant experience
Background in nonclinical toxicology study data structure and workflows
Familiarity with regulatory submission requirements and processes