The candidate should have hands-on experience translating complex scientific and business problems into structured requirements, defining AI use cases, developing acceptance criteria, managing UAT, and supporting AI/ML and Generative AI initiatives within pharmaceutical R&D environments.
Data Statistics and Programming
Bachelor''s or Master''s degree in Life Sciences, Health Sciences, Pharmacy, Biotechnology, Biomedical Sciences, or a related discipline
Strong experience in Clinical Research, Clinical Development, Translational Science, Oncology, or related therapeutic areas
8+ years of experience working within Pharmaceutical R&D organizations
8+ years of experience in Business Analysis and Requirements Gathering
5+ years of experience defining KPIs, success metrics, and measurable business outcomes
Strong understanding of the clinical development lifecycle and pharmaceutical development processes
Ability to translate ambiguous business problems into structured functional and AI-ready requirements
Experience with UAT planning, execution, stakeholder communication, and release readiness
Understanding of AI/ML concepts and Generative AI solutions
Experience with AI products, analytics platforms, or intelligent automation
Knowledge of Prompt Engineering, AI Agents, LLM-based workflows
Agile/Scrum experience with Jira or Azure DevOps
GxP / Computer System Validation (CSV) knowledge
Basic SQL for data validation and analysis
Basic Python for exploratory data analysis
Partner with Product Managers, Business Leads, AI Leads, and Data Leads to define AI use cases, success criteria, and measurable outcomes.
Translate business and scientific needs into AI-ready requirements covering data inputs, model outputs, recommendations, workflows, prompts, and dashboards.
Apply clinical research and pharmaceutical development knowledge to ensure AI solutions align with scientific and business objectives.
Act as the bridge between business stakeholders and technical/AI teams.
Perform current-state and future-state analysis, requirements refinement, prioritization, and feasibility alignment.
Create user stories, functional requirements, AI requirements, and detailed acceptance criteria.
Define AI input/output specifications and success metrics in collaboration with Data and AI teams.
Develop and maintain requirements and user stories in Jira/Azure DevOps.
Prepare URS/FRS, process flows, data flows, impact assessments, and source-to-target mappings as required.
Plan and execute User Acceptance Testing (UAT), including test scenarios, test cases, defect tracking, retesting, and business sign-off.
Partner with testing teams to ensure requirements are clear, testable, and aligned with expected system behavior.
Provide regular status updates covering progress, risks, issues, dependencies, and decisions.
Work collaboratively with scientists, clinicians, AI engineers, data teams, and product leadership.
User Stories and Acceptance Criteria
URS / FRS documentation
Current-State and Future-State Process Flows
Data Flows and Source-to-Target Mappings
AI Input/Output Definitions
KPI and Success Metric Definitions
UAT Plans, Scenarios, and Test Cases
UAT Defect Tracking and Retesting
UAT Test Summary Reports
Business Requirements and Functional Specifications
Status, Risk, Issue, and Dependency Updates