Satish G.

Satish G.

Pfizer/Seagen — Director, Veeva Development & Commercial Cloud Solutions @ Pfizer

About

When a drug fails to reach patients on time, it's rarely a science problem — it's a systems problem. For 18 years, I've been the person pharma organizations call to fix that. At Seagen/Pfizer and Eli Lilly, I built and governed the digital infrastructure that keeps clinical trials moving, regulatory submissions clean, and AI deployments compliant — across some of the most complex, high-stakes technology environments in the industry. Veeva Vault at enterprise scale. AI/ML governance frameworks that satisfy FDA and EU AI Act scrutiny. Clinical data management platforms and digital health solutions that reduced study start-up timelines by 30% through targeted process optimization. What I do differently is treat platforms as products, data as a strategic asset, and AI as an embedded capability — not a bolt-on. That philosophy has translated into a ~30% reduction in study start-up timelines at Seagen, a Veeva Vault Center of Excellence that became the operating standard across R&D and Commercial, and AI governance frameworks that held up under regulatory inspection. I've led organizations of 45+ across internal teams and strategic partners. I've managed multi-million-dollar portfolios. And I've done it in environments where "good enough" isn't acceptable — because patients are waiting on the other side of every delayed milestone. What I bring to the table:•     End-to-end product ownership across clinical and commercial platforms•     Enterprise AI governance — FDA GMLP, EU AI Act, model validation, risk tiering•     Veeva Vault (Clinical, RIM, QMS, PromoMats) at enterprise scale•     Cross-functional leadership across Quality, Regulatory, Legal, and IT•     GxP, 21 CFR Part 11, and inspection-ready documentation practices•  Agile product delivery across regulated R&D and Commercial platform ecosystems•  Model validation, risk tiering, and RegTech governance aligned with FDA GMLP and EU AI Act•    Cross-functional stakeholder management across Quality, Regulatory Affairs, Legal, and ITI’m currently exploring Director to VP-level opportunities in pharma technology, digital clinical platforms, AI governance, and product leadership — where execution matters as much as vision.If you’re building something that needs to actually work in a regulated environment, let’s connect.

Country

United States

City

Bothell

Industry

Biotechnology

Skill

AI Product Governance, Stakeholder Management, Generative AI, Product Owner, Digital Health, Model Validation, Platform Strategy, Regulatory Technology (RegTech), Study Start-up Optimization, Clinical Data Management, Agile Product Delivery, Supply Chain Management, Program Management, Management, Product Management, Operations Management, Project Management, Requirements Analysis, Agile Project Management, ERP

Experience

Pfizer

Pfizer/Seagen — Director, Veeva Development & Commercial Cloud Solutions

Pfizer

LinkedIn
2021-1 - Present · 5 yrs 9 mos

Served as Product Owner and platform strategy lead for Pfizer's global Veeva Vault ecosystem — spanning CTMS, eTMF, Clinical Data Management, and Commercial operations spanning Clinical, Regulatory, and Commercial operations — managing a multi-million-dollar portfolio and a 45+ person global organization of internal leaders and strategic partners. Platform & Product Leadership Transformed a system-centric implementation model into a product- and platform-led operating model — enabling scalability, reuse, and faster time-to-value across CTMS, eTMF, and Development Cloud. Established the Enterprise Veeva Vault Center of Excellence with standardized governance, operating models, and multi-year roadmaps that improved delivery predictability and strengthened regulatory confidence. AI & Innovation Sponsored Generative AI, AI/ML, and automation initiatives targeting study start-up optimization within GxP-regulated clinical platforms — applying model validation and risk-tiering frameworks to deliver ~30% reduction in cycle times, improving data quality, and accelerating database lock and submission readiness. Directly enabling faster patient access to therapies. Compliance & Governance Maintained sustained inspection readiness across a mission-critical R&D and Commercial digital ecosystem. Drove disciplined investment prioritization and measurable ROI across an enterprise platform portfolio. Commercial & Clinical Data Management Governed enterprise clinical data management and content platforms including Veeva Vault PromoMats, Medidata, and analytics ecosystems (Power BI, Tableau, Appian) — ensuring data integrity, operational resilience, and regulatory submission readiness across global clinical programs and commercial operations. Regulatory Technology & Compliance Maintained sustained inspection readiness across a mission-critical digital ecosystems. Leadership Philosophy Platforms as products. Data as a strategic asset. AI as an embedded capability — not a pilot.

Eli Lilly and Company

Associate Director, Clinical Digital & Governance Solutions | Eli Lilly & Company

Eli Lilly and Company

LinkedIn
2014-4 - 2021-1 · 6 yrs 10 mos

• Compressed Veeva Vault platform deployment timelines across Clinical Operations, RIM, and QMS by building a scalable product ownership and vendor governance model — improving platform health, reducing enhancement cycle times, and delivering consistent SLA performance across a global user base. • Strengthened GxP compliance and 21 CFR Part 11 readiness across Lilly’s clinical and commercial digital ecosystem by embedding AI-enhanced workflow governance controls — enabling Lilly to pass regulatory inspections with zero critical findings on managed platforms. • Accelerated clinical data quality and analytics maturity across R&D by partnering with Regulatory Affairs, Quality, and Procurement to align digital innovation with global compliance standards — reducing manual data reconciliation effort and improving downstream reporting accuracy. • Drove technology adoption and operational value realization across R&D functions by leading enterprise-wide change management and enablement programs — ensuring platform investments translated into measurable productivity gains rather than shelfware. • Elevated organizational inspection readiness by championing enterprise governance forums focused on CAPA tracking, data quality, and audit trail integrity — building a compliance culture that proactively identified and closed gaps before regulatory scrutiny. • Drove Agile product delivery and digital transformation programs across Veeva Vault and Medidata ecosystems — building governance structures that served as the precursor to Pfizer's Center of Excellence model.

Saven Tech

Director, AI & Digital Transformation Advisory | Saven Technologies

Saven Tech

LinkedIn
2009-5 - 2014-4 · 5 yrs

• Accelerated pharma and biotech clients’ AI governance maturity by designing enterprise risk frameworks and regulatory-aligned digital transformation roadmaps — enabling clients to deploy AI/ML capabilities with confidence in GxP-regulated environments. • Reduced vendor selection cycle times and implementation risk for mid-to-large pharma organizations by leading structured platform assessments for Veeva Vault, Salesforce Commercial Cloud, and marketing automation tools — delivering business cases that secured executive buy-in and capital approval. • Built commercial and medical affairs technology roadmaps for multiple life sciences clients by translating complex business requirements into executable platform strategies — shortening time-to-value for CRM, content management, and analytics platform deployments.

Education

Stevens Institute of Technology

Stevens Institute of Technology

LinkedIn

Management of Artificial Intelligence, GenAI & Machine Learning

2025-1 - 2026-5 · 1 yr 5 mos
Purdue University Daniels School of Business

Purdue University Daniels School of Business

LinkedIn

Management Information Systems, General

The Wharton School

The Wharton School

LinkedIn

Artificial Intelligence — Machine Learning, Deep Learning, blockchain, and robotic automation

2023-3 - 2023-7 · 5 mos

* Evaluate the growth potential and evolution of disruptive technologies. * Compare successful and unsuccessful disruptive technology business ventures. * Identify current and future machine learning, deep learning (DL), and artificial intelligence applications. * Examine how using robots for automation will transform organizational operations. * Identify potential applications of blockchain technology within various industries. To be prepared for the future, you must understand the technology that will drive it. The faculty experts at the helm of the Technology Acceleration Program have scanned the horizon to evaluate how today’s emerging technologies—Non-Fungible Token (NFTs), artificial intelligence, and smart devices—could transform into the technologies of the future. You will take in a broad scope of technologies from robotic process automation to smart contracts, exploring their potential impacts on how you organize, finance, and operate your enterprise.

Indiana State University

Indiana State University

LinkedIn

Sciences/Computer Science

Satish G.'s Contact Information

Email

******@***.com

Phone

(**) *** ****

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