Owns the roadmap and delivery of end-to-end SPVG technology solutions across case intake/processing, signal, aggregate reporting, submissions, QPPV oversight, literature, and safety analytics—balancing speed, compliance, and value
Job Summary
Owns the roadmap and delivery of end-to-end SPVG technology solutions across case intake/processing, signal, aggregate reporting, submissions, QPPV oversight, literature, and safety analytics—balancing speed, compliance, and value.
Chairs innovation councils with customers and partners; converts problem statements into pilots/PoCs with clear success criteria and scales proven patterns into offering.
Design and build minimally viable AI/ML prototypes and proof of concepts (POCs) including LLM-based agents and automation solutions, using tools such as OpenAI, Azure OpenAI, Microsoft Copilot, and related platforms.
Matching Summary
Owns the roadmap and delivery of end-to-end SPVG technology solutions across case intake/processing, signal, aggregate reporting, submissions, QPPV oversight, literature, and safety analytics—balancing speed, compliance, and value.
Skills & Requirements
Must-have
roadmap and delivery of SPVG technology solutions
cross-functional execution with vendors/SIs
innovation councils with customers and partners
AI/NLP/RPA, data platforms, cloud
design and build AI/ML prototypes
embed risk-based quality, privacy, security
Nice-to-have
accelerate customer success
drug development mindset
passionately problem solvers
continuously building the company
Key Requirements
Validated deployments (CSV, 21 CFR Part 11, EU Annex 11, GAMP 5)
Experience with OpenAI, Azure OpenAI, Microsoft Copilot
Experience with AI model validation, monitoring, explainability