Executive Profile
Sheilah
Johnson-Rocha
Chief AI & Innovation Officer
Clinical Research & Life Sciences · Founder & CEO, Aurelyn AI Clinical
MSc. · MMC · CMBC · MAPM · AIEd · TESOL
21+ years of clinical research and development leadership across oncology, cell & gene therapy, and rare disease — now translating that regulated-industry depth into responsible, protocol-aware AI transformation for life sciences organizations.
Executive Profile
Chief AI and innovation executive with 21+ years of clinical research and development leadership across oncology, cell and gene therapy, rare disease, clinical operations, and global trial delivery. Combines deep regulated-industry expertise with AI/ML, generative AI, LLMs, NLP, document intelligence, cloud platforms, and responsible AI governance to translate clinical and regulatory complexity into scalable enterprise innovation. Proven builder of AI-enabled platforms, clinical intelligence engines, workforce learning ecosystems, and digital operating models — experienced partnering across Clinical Development, Operations, Regulatory, Quality, Product, Engineering, Data Science, and executive leadership to establish AI strategy, governance, adoption, and measurable business value.
Enterprise AI Strategy & Transformation
Defines AI vision, use-case portfolios, operating models, adoption roadmaps, and value realization strategies for regulated clinical research organizations.
Responsible AI & Governance
Translates ICH GCP, 21 CFR Part 11, FDA expectations, EU AI Act, GDPR, and AI risk-management principles into practical governance, human oversight, and control frameworks.
Clinical AI Product Innovation
Architects AI-enabled clinical systems spanning evidence consistency, document intelligence, eTMF workflows, protocol requirements, and workforce enablement.
Executive Innovation Leadership
Bridges clinical science, operations, technology, product, and data teams to move AI initiatives from concept into scalable, governed implementation.
AI Workforce Enablement
Builds role-based AI education and adoption strategies that increase knowledgeable, responsible, and compliant AI use across clinical organizations.
Transformation Impact
Selected outcomes from building Aurelyn AI Clinical and leading clinical operations for global sponsors and CROs.
Courses and modules independently architected for the Aurelyn AI Clinical Academy, drawing 8,000+ unique site visits within 7 days of launch.
Architected Aurelyn Clinical Engines™, including eTMF Intelligence and Clinical Evidence & Consistency capabilities for document intelligence and traceability.
Staff supported by enterprise resourcing and forecasting technology she designed and developed.
Project managers led directly, with 100+ cross-functional staff directed indirectly across oncology and cell therapy programs.
In strategic negotiations led across rare disease and advanced-therapy agreements.
IQVIA's inaugural cell and gene therapy trial delivered ahead of schedule following an early eTMF pilot she implemented with GSK.
Study Timeline — Career Tenure by Organization
Sponsor-side, CRO-side, and founder chapters across 21+ years, 2009 – Present.
Professional Experience
Select any role to expand the full record. Presented most recent first.
Founder & Chief Executive Officer
Aurelyn AI Clinical for Life SciencesFounder
2026 – Present
- Sets enterprise vision and product strategy for an AI-focused clinical research company designed to modernize regulated clinical development through responsible, protocol-aware, evidence-driven AI.
- Architected Aurelyn Clinical Engines™, including the eTMF Intelligence Engine and Clinical Evidence & Consistency Engine™, translating clinical workflows and regulatory requirements into AI-enabled governance and intelligence capabilities.
- Built Aurelyn AI Clinical Academy independently — 40+ courses, 541+ modules, and 8,000+ unique site visits within 7 days.
- Developed The eTMF Lab, combining clinical study simulation, AI tutoring, filing challenges, and mock inspection experiences to accelerate workforce capability.
- Defines responsible AI strategies incorporating human oversight, traceability, risk controls, and alignment with ICH GCP, FDA frameworks, 21 CFR Part 11, EU AI Act, and GDPR.
- Leads AI product strategy, platform development, curriculum architecture, market research, customer discovery, partnerships, sponsorship, and go-to-market execution.
Director, Project Management & Clinical Operations
Takeda — Oncology & Cell Therapy LeadershipSponsor
Oct 2022 – Mar 2023
- Built operating infrastructure for an Oncology and Cell Therapy unit, establishing SOPs, role architecture, dashboards, governance, and AI-enabled onboarding.
- Led 13 project managers and indirectly directed 100+ cross-functional staff, establishing critical-path, KPI, risk, and accountability frameworks.
- Developed SaaS and AI-enabled clinical analytics solutions to improve workflow management, visibility, and operational decision support.
- Developed enterprise resourcing technology supporting 44,000 staff, strengthening forecasting, resource utilization, and financial planning.
- Connected clinical operations, investigator engagement, patient recruitment, vendor oversight, and digital innovation to improve portfolio execution.
Director, Portfolio Strategy & Delivery
Ergomed — Rare Disease / Cell & Gene TherapyCRO
Mar 2022 – Jun 2022
- Directed global early-phase portfolio strategy, governance, critical-path planning, resource allocation, and data-driven performance monitoring.
- Partnered on cohort planning, KPIs, decentralized strategies, vendor selection, proposals, budgets, and post-M&A SOP refinement aligned with ICH GCP.
Director, Pediatric & Rare Disease
Premier Research LLC — Gene and Cell TherapyCRO
Mar 2021 – Mar 2022
- Led global recruitment strategy for an ultra-rare pediatric trial, identifying four children worldwide and designing patient-centered delivery models.
- Directed governance, cohort strategy, decentralized and home-health innovation, resource allocation, and cross-functional portfolio execution.
Senior Project Lead
Parexel — Gene/Cell Therapy Portfolio & Therapeutic StrategyCRO
May 2019 – Mar 2021
- Designed strategic delivery frameworks and adaptable operating scenarios for complex rare disease and advanced therapy programs.
- Led high-value negotiations supporting agreements exceeding $40M / £30M and designed mitigation strategies during COVID-19 disruption.
Oncology Senior Project Manager / Line Manager
Syneos HealthCRO
Oct 2018 – Apr 2019
- Built operating plans, SOPs, role architecture, and the delivery framework for a new FSP business unit.
- Led talent and client-functional workstreams while redesigning clinical operations responsibilities to reduce WBS redundancy.
Oncology Senior Project Manager
IQVIACRO
Aug 2016 – Sep 2018
- Led IQVIA's inaugural cell and gene therapy trial, designing the operational and cohort management strategy for enrollment, real-time data, sample collection, and safety review.
- Directed CRAs and CTAs and managed quality, risk, change, functional alignment, and Data Safety Monitoring Board operations.
Senior Project Manager
CovanceCRO
Jul 2015 – Jul 2016
- Led global project teams across scope, schedule, quality, risk, budget, and delivery, applying Six Sigma and analytics to strengthen project controls.
- Served as Bid Defense Lead for therapeutic-area opportunities supporting small biotechnology growth.
Oncology Clinical Disclosure Lead / Process Manager
GlaxoSmithKlineSponsor
Jul 2012 – Jul 2015
- Created a clinical data transparency framework for public disclosure and developed an early CSR data anonymization procedure balancing transparency and patient privacy.
- Managed oncology disclosure data, timelines, protocol synopses, and clinical trial result summaries.
Global Oncology Asset Lead / Supervisor, Central Regulatory Records
GlaxoSmithKlineSponsor
Nov 2009 – Jul 2012
- Led system build, UAT, and implementation of an early eTMF pilot, contributing to dabrafenib trial delivery one month ahead of schedule.
- Appointed Oncology Business Unit Inspection Readiness Manager following an FDA 483, establishing centralized electronic oversight of quality metrics, SOPs, and processes.
Speaking & Thought Leadership
Selected keynote and panel engagements sharing perspective on AI transformation, mentorship, and leadership in life sciences.
Mentorship in Motion: Lifting as We Lead
All Things Women Summit — hosted by Dr. Alicia Newsome
Spoke on building mentorship pathways for women in leadership, translating personal transformation into organizational impact, and lifting others while leading through change.
Core Competencies
AI Strategy & Executive Leadership
Clinical Development & Operations
Credentials & Education
MSc., Management / Healthcare Administration
Colorado State University Pueblo
BBA, Legal Studies
Strayer University
AS, Business Administration
Strayer University
Microsoft AI Data Engineer Career Path Program Completion (Assessment)
November 2025 · 77+ hours · 28 learning paths · 109 modules
Spanning AI/ML, generative AI, LLMs, NLP, computer vision, Azure AI, document intelligence, responsible AI, cloud deployment, and security.
Additional credentials: PMI Generative AI for Project Management · PMI Data Landscape for Gen AI in PM · AI Essentials for Project Managers · AI for Business Operations · Master Management Consultant · Certified Master Business Consultant · Lean Six Sigma Foundations · advanced AI platform training.
Technology & Platforms
Cloud & AI
- Microsoft Azure
- Azure AI
- Generative AI
- LLMs
- NLP
- Document Intelligence
- AWS
Clinical Systems
- Veeva
- Medidata
- EDC
- SharePoint
- PowerApps
Analytics & Enterprise
- Tableau
- Salesforce
- Oracle
- IBM Cognos
Product & PM
- Jira
- Trello
- SaaS / PaaS Product Development
Industry Engagement
Section 9.0 — Contact
Let's build what's next in clinical AI.
Open to Chief AI Officer, innovation executive, and advisory conversations across clinical research, biotech, and life sciences.