Gxp Business Analyst Jobs (NOW HIRING)

Foster City, CA 94404 (Hybrid with 3 Days onsite)

Salary – Market (DOE)

Full-Time / Direct-Hire

We are looking for a Scientific Business Analyst with AI experience who combines life sciences expertise with business analysis and AI product delivery. This role will partner with Product Managers, Business Leads, AI Engineers, and Data teams to define and deliver AI-powered solutions that support clinical research and drug development. The ideal candidate has a strong scientific background, understands clinical development processes, and can translate complex business needs into structured AI requirements that enable successful product delivery. This position is for customer who can able to independently handled all BA AI Scientific experience.

• Strong understanding of clinical development lifecycle and pharmaceutical development processes
• 8+ years of experience working within pharmaceutical R&D organizations
• 8+ years of excellent business analysis and requirements gathering skills
• Ability to convert ambiguous business problems into structured functional requirements
• 5+ years of Experience defining KPIs, success metrics, and measurable business outcomes
• Strong written and verbal communication skills; Self-driven with ability to work independently
• Experience managing UAT activities and stakeholder communication; Demonstrated understanding of key clinical development concepts
• Bachelor's or Master's degree in Life Sciences, Health Sciences, Pharmacy, Biotechnology, Biomedical Sciences, or related discipline
• Academic or professional experience supporting clinical research, clinical development, translational science, oncology, or related therapeutic areas

• Translate business needs into AI-ready requirements - Input data expectations, Model outputs (predictions, insights, recommendations) and User interaction patterns (e.g., workflows, prompts, dashboards)
• Individual contributor partner with Product Manager, Business Lead, AI Leads, and Data Lead to define AI use cases, including problem framing, success criteria, and measurable outcomes
• Apply foundational knowledge of clinical research and drug development to ensure AI use cases, requirements, and acceptance criteria accurately reflect scientific intent and business objectives
• Document user, functional and AI-specific requirements including data inputs, model output, user interaction workflows with acceptance criteria aligned to business outcomes and system behavior
• Leads requirements refinement, including current/future state analysis, requirements documentation, prioritization, feasibility alignment and stakeholder alignment
• Act as the primary bridge between “what’s needed” (business) and “what’s possible” (technical) to ensure stakeholder alignment
• Owns User Acceptance Testing planning and execution; Partners with Testing team to ensure requirements are testable and the solution is ready for release
• Strong interpersonal skills to build and maintain productive relationships with team members; Communicate effectively with internal and customer stakeholders
• Prior experience in working on Agile/Scrum projects with exposure to tools like Jira/Azure DevOps

• Update and maintain user stories and acceptance criteria in Jira/ADO
• Author formal User Requirements Specification (URS)/Functional Requirements Specification (FRS), when required
• Partners with testing teams to ensure requirements are clear, unambiguous, and testable
• Produce current state and future state artifacts (process flows, data flows, impact summaries) as required to support solution design
• Lead or contribute to data specifications, source-to-target mappings, and AI input/output definitions in partnership with Data and AI teams
• Develop User Acceptance Test (UAT) Plan, scenarios, and test cases aligned to approved requirements
• Lead UAT, including coordination of test cycles, defect logging, and retesting
• Produce UAT test summary report supporting business acceptance and release readiness
• Provide regular status updates covering progress, risks, issues, and dependencies
• Document decisions, assumptions, and clarifications related to contracted scope

Secondary Skills / (Good to have

• Understanding of AI/ML concepts and Generative AI solutions; Knowledge of prompt engineering, AI agents, or LLM-based workflows
• Experience with AI products, analytics platforms, or intelligent automation initiatives; Basic Python for exploratory data analysis
• Experience working in Agile and iterative product delivery; GxP / Computer System Validation (CSV) knowledge
• Basic SQL for data validation and analysis; Familiarity with Jira or Azure DevOps

• Successfully understand business priorities, clinical workflows, and AI product roadmap
• Partner with stakeholders to define and document high-quality AI use cases and requirements
• Deliver complete business analysis artifacts including User Stories, URS/FRS, process flows, and acceptance criteria
• Establish clear AI input/output definitions and success metrics for prioritized initiatives
• Successfully lead User Acceptance Testing and support multiple AI solution releases
• Improve collaboration between scientific stakeholders and AI engineering teams, reducing requirement ambiguity and delivery delays
• Contribute to the successful rollout of AI capabilities supporting clinical development and drug discovery initiatives
• Become a trusted business partner for AI-enabled scientific product development