Domain SME - Pharmaceutical & Clinical Development
Space Inventive
About the Role
We are seeking experienced Domain Subject Matter Experts (SMEs) to support AI-powered initiatives across Clinical Operations, Safety, Regulatory, and Medical Affairs. The Domain SME will bridge the gap between clinical development business processes and AWS AI/ML technical delivery, providing critical domain context during the discovery, scoping, and validation of AI use cases.
Key Responsibilities
- Participate in discovery workshops with business stakeholders to validate problem statements, current processes, and desired outcomes
- Provide pharmaceutical clinical development domain expertise to guide AI use case scoping and feasibility assessment
- Translate complex business requirements into structured inputs for AI/ML engineering teams
- Support T-shirt sizing (S/M/L) of use cases with domain-informed effort estimates
- Validate AI-generated prototypes and POC outputs against business process reality
- Contribute to Working Backwards sessions, ensuring customer outcomes remain central to solution design
- Support the creation of project charters, user personas, and journey maps
- Collaborate with AWS Data Scientists and App Architects in multi-disciplinary squads
Requirements
- 5+ years in pharmaceutical clinical development, clinical operations, pharmacovigilance, regulatory affairs, or medical affairs
- Deep understanding of drug development lifecycle, GxP-regulated processes, and specific systems (Veeva, NGDP, SPINE, FREEWAY preferred)
- Experience working as a business analyst, product owner, or domain SME on digital transformation or AI/ML programmes in life sciences
- Strong workshop facilitation and stakeholder engagement skills
- Ability to translate between business language and technical requirements
Nice to Have
- Prior experience with large pharma enterprises.
- Familiarity with AI/ML concepts, GenAI, and agentic workflows
- Experience with Agile/Scrum delivery in regulated environments
- Understanding of ICH guidelines, FDA/EMA regulatory frameworks