Sheela Iyer
Anaheim,CA
Summary
Proven transformational leader with therapeutic area domain experience in managing critical data science and other initiatives in GxP/non-GxP domains. Strategic- thinking individual with experience across several verticals such as MedTech, Pharmaceuticals, Healthcare and Semiconductor sectors. Skilled in utilizing AL/ML and other emerging technologies, Agile methodologies, hybrid cloud environments and various technology stacks to drive success. Known for fostering high-performance teams, driving change, promoting diversity, equity, and inclusion while maintaining a strong commitment to relationships, accountability and trust.
Overview
17
17
years of professional experience
6
6
Certifications
Work History
Director Associate - Products
Janssen Pharmaceuticals - JRD Datascience
Titusville, Pennsylvania
10.2017 - Current
- Key Divisional Product Leader instrumental in managing several highly critical, complex and innovative Data science initiatives in the GxP (First of its kind hybrid trial universe, Medical Imaging Platform) and non-GxP domains (Oncology Research Biomarker Information Tower, Clinical Trial Feasibility, Optimization) using AI/ML, Agile methodologies, Hybrid cloud (AWS, Google, Azure) & other technology stacks (multi-Omnics, clinical data and RWD data)
- Successfully increased the portfolio with over 15+ active launches, led the growth of the team to 20 from ground up and tripled product return on investment.
- Developed high-performing teams by providing consistent mentorship and growth opportunities, instilling a strong commitment to accountability, trust, and embracing change. This resulted in a positive work environment, increased employee engagement, higher retention rates, and improved team morale.
- Established the first of its kind Innovative Data Stewardship and governance strategy and process flows. Developed and deployed platforms to automate clinical data governance. Extensive knowledge on Regulatory policies, FDA guidance (21 CFR) related to Real-world Evidence and use of Artificial Intelligence/Machine Learning for electronic health records (EHRs) (Structured, unstructured and medical claims data in clinical studies & Clinical Feasibility.
- Published abstracts for highly critical use-cases at the R&D Data science Symposium & regular speaker at external Events.
- As a Data science and Digital Health CAPA Champion, pioneered data governance and compliance and facilitated cross-organization improvements with improved decision-making. Improved 10 projects as a process improvement expert with strategic planning, resource allocation, and time management practices.
- Regular interactions with key executive leadership to discuss strategy, portfolio and change management. Secured key partnerships, mergers and acquisitions such as Tear science, Abbott, McAfee that contributed to the company's overall growth strategy and market reach.
Sr. Technical Program Manager
Intel Corporation
Folsom, California
01.2009 - 10.2017
- Successfully led multiple programs in chipset (ASIC) development, Internet of Things Cloud Platform and Emerging technologies such as Minnow Board (Intel’s First Open Source hardware program), RealSense (VR Technology) and Immersive Shopping
- Managed large-scale technology deployments successfully while maintaining minimal disruption to ongoing operations during the transition period.
- Championed process improvements for increased efficiency, analyzing existing workflows and recommending enhancements. Led 5 IT projects where incidents reduced by 80% and the environment complexity rose by 200%.
- Institutionalized best practices for application development and project management to ensure consistent delivery of quality projects across the organization using Agile/SCRUM/JIRA methodologies
- Established an technology governance program and implemented a standardized program management toolset.
- Negotiated contracts skillfully with external service providers securing favorable terms that contributed positively towards company profitability.
- Spearheaded strategic planning sessions to align technical objectives with organizational goals and market demands. Represented Intel IT at various summits such as CES, Microsoft Summit, Federal Reserve of Brazil.
Education
Master of Science - Management Information Systems
University of Illinois
Chicago, IL 05.2001 -
Master of Science - Data Science And Business Analytics
University of Texas At Austin
Austin, Texas 05.2001 -
Skills
Visionary leadership
SoC, AI, Data Technology Program and Product management
Operations and Team management
Relationship building
Strategic planning and Decision-making
Business planning and Staff management
Creativity, Problem Solving and innovation
Budget and negotiation management
Regulatory compliance including 21CFR and GxP
Change Management and Process improvement
Certification
PMP - PMI
Awards
- Business Impact Award - Johnson and Johnson
- Recipient of several Division Recognition Awards at Intel (2009, 2011, 2012, 2013, 2014, 2015, 2016)
- Excellence awards (webmd.com)
- Johnson and Johnson Women’s leadership Co-Chair – STEM, Agile Coach
- CrestCom International – Bulletproof Manager – Leadership Training
Publications
Med.ai - ORBIT: Delivering Rapid Data Access and Insights to Accelerate Precision Medicine, Sheela Iyer et al.
Volunteering
Volunteer Judge – Orange County Science and Engineering Fair (OCSEF), Intel ISEF
Orange County Second Harvest
Timeline
Director Associate - Products
Janssen Pharmaceuticals - JRD Datascience
10.2017 - Current
Sr. Technical Program Manager
Intel Corporation
01.2009 - 10.2017
Master of Science - Management Information Systems
University of Illinois
05.2001 -
Master of Science - Data Science And Business Analytics
University of Texas At Austin
05.2001 -
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