Peter Buniak
Open menu
Life sciences technology

Career Portfolio

Life Sciences Chief Information Officer — IT organization builder, business transformation, governance, and strategic planning in regulated environments.

Executive Summary

Executive IT leader who has brought multiple products through FDA and commercialization. Leads M&A due diligence and integration, built a Cybersecurity program with Board approval, and improved IT–business alignment through IT Governance (ITGC) and Enterprise Architecture. Transformed business services to cloud and SaaS, redesigned IT SOPs for FDA and Sarbanes-Oxley (SOX) compliance, and specializes in building or transforming IT organizations with strategic plans, KPIs, and high-performing culture.

Peter has worked in life sciences for over 25 years across IT, digital marketing, business operations, and corporate strategy — from R&D and clinical operations through commercialization. Experience spans large multi-national pharma and biotech startups, including M&A due diligence, FDA-regulated product launches, and founding and scaling technology-driven companies.

Peter Buniak

Project Types & Services

Representative categories of projects and services delivered across pharmaceutical, biotech, and life sciences technology engagements:

IT Service Management (ITSM)

Design and launch service management practices — incident, problem, and change — to improve quality of IT services in regulated environments.

  • ITSM
  • Incident Management
  • Problem Management
  • Change Management
  • Service Quality

GxP Validation & Regulatory Compliance

Validated systems, SOPs, and audit-ready documentation for FDA-regulated R&D, clinical, QA, and manufacturing environments.

  • GxP
  • 21 CFR Part 11
  • Validation
  • SOPs
  • FDA
  • eCTD
  • eTMF
  • ELN
  • LIMS

SOX & IT General Controls (ITGC)

SOX readiness programs, IT general controls, and control frameworks aligned with Sarbanes-Oxley and internal audit requirements.

  • SOX
  • ITGC
  • Internal Controls
  • Audit Readiness
  • Compliance

Digital Transformation

Enterprise-wide technology roadmaps for R&D, clinical operations, regulatory affairs, finance, and commercial launch readiness.

  • Digital Transformation
  • Cloud Migration
  • SaaS
  • Oracle Cloud
  • Veeva Vault
  • Enterprise Content Management

Cybersecurity & Data Integrity

Security program development, employee training, and data integrity controls with board-level governance and executive sponsorship.

  • Cybersecurity
  • Data Integrity
  • Security Practice
  • Risk Management

Enterprise & Business Architecture

Capability roadmaps, business transformation methodology, and future-state architecture linking strategy to technology investments.

  • Enterprise Architecture
  • Business Architecture
  • Capability Roadmapping
  • Process Re-engineering
  • IT Governance

M&A Due Diligence & Integration

Technology due diligence, integration planning, and organizational alignment during mergers, acquisitions, and divestitures.

  • M&A
  • Due Diligence
  • Integration
  • Post-Merger IT

Commercial Launch & Digital Marketing

Launch-readiness roadmaps, non-personal promotion, SEO, paid search, field sales support, and multi-channel ROI analytics.

  • Commercial Launch
  • Digital Marketing
  • Multi-Channel
  • ROI Analytics
  • HCP Engagement

IT Organization Building & Transformation

Organizational design, talent retention, outsourcing strategy, KPIs, and high-performing culture in startup and enterprise settings.

  • Org Design
  • Change Management
  • Outsourcing
  • KPIs
  • Culture

Pharma IT Differentiators

Pharmaceutical and biotech companies require IT that goes beyond infrastructure — understanding these nuances is critical to delivering value.

Differentiator IT Implication
Speed to Market Act quickly while abiding by GxP regulations and validated system controls
Intellectual Property Strong data governance, access controls, and user training to protect IP
Partnerships Collaboration tools and policies for investors, CROs, and strategic partners
Dynamic Strategy Agile resource shifting for M&A, commercial launches, and FDA audits
GxP Regulations Validated systems, strong processes, and audit-ready documentation
SOX & ITGC IT general controls, SOPs, and Sarbanes-Oxley readiness for public and pre-IPO companies

Read the full framework in Life Sciences CIO: Making IT Not Suck.

Experience

Founder

AIthl33t

Boston, MA

  • Founded AIthl33t, an umbrella platform for AI-powered youth sports skill progression across multiple sports
  • Building products connecting clubs, coaches, parents, and athletes with verified, standards-based player development
  • Applying life sciences technology leadership and responsible AI design to youth athletics products
  • Extending coaching philosophy from CommuniTri and Hit the Wall Ball into a multi-sport platform

Chief Operations Officer(COO)/ Chief Technology Officer (CTO)

Revalia Bio

New Haven, CT

  • Founded and scaled a life sciences tech and data company to 25 employees with 8,500 sq. ft. lab and office space
  • Negotiated and executed tech transfer of Human Organ Digital Twin IP from Yale University
  • Co-led fundraising efforts, helping raise $19M in pre-seed and seed capital from top-tier investors
  • Built and managed a 10–15 person full-stack engineering team delivering a GxP-ready, scalable platform successfully commercialized
  • Launched Finance & Accounting operations with investor-grade reporting, dashboards, and a unique chart of accounts
  • Led development of modular human organ perfusion hardware with real-time data capture and adaptive machine learning
  • Established Quality Assurance and PMO functions ensuring data integrity, regulatory compliance, and security across human organ data trials
  • Pioneered high-performance culture emphasizing psychological safety, innovation, and continuous improvement

Senior Vice President & Chief Information Officer

Kadmon Pharmaceuticals

New York, USA

  • Digitally transformed R&D, Clinical Operations, and Regulatory; realigned IT organization to company roadmap and commercial launch strategy
  • Defined and launched IT Service Management (Incident, Problem, Change) from level 0 maturity; measured and optimized service performance
  • Initiated and led SOX readiness program in IT — updated and created SOPs and IT General Controls (ITGC)
  • Established Cybersecurity program addressing data integrity gaps; gained Board of Directors approval and support
  • Led digital transformation for commercial product launch readiness — non-personal promotion, SEO, paid search, analytics, field-sales support
  • Created roadmap to eliminate technical debt — Oracle EBS to Cloud, OBIEE to Analytics Cloud, Hyperion to PBCS, Documentum to Veeva Vault
  • Supported company through two commercial product launches and Sanofi acquisition ($1.9B)

Senior Director, Enterprise Architecture & IT Strategic Shared Services

Kadmon Pharmaceuticals

New York, USA

  • Built Business Architecture, Business Analysis, Process Re-engineering, and Project Management practice
  • Created and managed strategic roadmaps for Clinical and R&D organizations
  • Standardized IT governance, project health, budget, and resource reporting for executive ROI decision-making
  • Improved internal customer satisfaction through standardized IT delivery methodology, workshops, and change management
  • Led process re-engineering across IT, Finance, R&D, Clinical, Regulatory, and QA — Office 365, Documentum, Oracle Cloud ERP, eCTD, eTMF, ELN, LIMS

Founder & Chief Technology Officer

Energize Technologies

New Jersey, USA

  • Founded life sciences technology services company; established strategic partnerships and promoted products and services
  • Reengineered and optimized business processes; architected long-term strategic technology roadmaps for pharma clients
  • Conceptualized, architected, and co-developed CommuniTri — a triathlon coaching platform with deeper social interaction
  • Created governance structure and business process for digital marketing across multiple international marketing teams
  • Established enterprise content management, document management, and collaboration processes for maturing life sciences clients

Multi-Channel Market Planning

Daiichi Sankyo

New Jersey, USA

  • Led customer targeting strategy and analytics for email, direct mail, EHR, ePocrates, and digital channels across six brands
  • Developed future-state vision and transformation roadmap for a 360-degree view of the physician customer
  • Created dashboard view of all non-personal digital promotion channels across five brands for HCP and patients
  • Created standard ROI methodology for non-personal digital promotion tactics, improving promotional mix decision-making

Senior Director, Business Architecture

Daiichi Sankyo

New Jersey, USA

  • Led organizational reengineering for Sales, Marketing, Operations, and Business Development using enterprise architecture principles
  • Created business transformation methodology leveraging enterprise architecture and capability roadmapping
  • Achieved $640K cost savings by optimizing corporate commercial business development assessment for M&A evaluation
  • Saved $520K by assessing multi-channel campaign management capability and optimizing vendor contract renegotiation
  • Achieved $1.4M value by optimizing resource allocation across marketing sciences and sales operations
  • Created $2.2M potential by optimizing pricing adjustment execution — minimizing speculative buying risk

Senior Manager, IT Strategy & Governance

Daiichi Sankyo

New Jersey, USA

  • Led strategy to make the entire IT function more valuable and efficient to the organization
  • Reduced overall IT operating budget by 10% ($3M) through organizational assessment, capability mapping, and future-state design
  • Retained 100% of high-value talent during organizational change through effective communications and change management
  • Defined new roles — business analysis, relationship management, business transformation, and business intelligence
  • Created outsourcing strategy for quality assurance; developed custom sourcing model and selected offshore vendor

IT Senior Project Manager, Web Developer & Lead Web Programmer

Daiichi Sankyo

New Jersey, USA

  • Progressed from web developer to lead programmer to senior project manager within five years
  • Built web applications and digital solutions for pharmaceutical marketing and internal operations
  • Managed enterprise IT projects in regulated environments with GxP considerations
  • Delivered systems implementations through requirements, design, validation, and deployment phases
  • Supported early digital marketing and multi-channel initiatives in a multi-national pharma organization

Education & Credentials

  • NYU Stern School of Business logo

    MBA, Strategy & Entrepreneurship

    New York University, Stern School of Business

  • Rochester Institute of Technology logo

    B.S. Information Technology (Honors)

    Rochester Institute of Technology

  • Project Management Institute logo

    PMP — Project Management Professional

    Project Management Institute

Leadership Competencies

  • Organizational Change Management
  • High Performing Teams
  • Innovation Management
  • Operational Excellence
  • Board Presentations
  • Strategic & Budget Planning
  • Vendor Management
  • Sourcing Strategy
  • Project Management
  • Business Process Engineering
  • Business Analysis
  • Enterprise Architecture