ICE Digital Ventures

Transforming Regulatory & Enterprise Platforms for the AI Era

Regulatory- undEnterprise-Plattformenfür das AI-Zeitalter transformieren

Executive leadership for AI, Regulatory, Safety and Digital Transformation in Life Sciences. From strategy to validated execution.

Executive Leadership für AI, Regulatory, Safety und digitale Transformation im Life-Sciences-Umfeld. Von Strategie bis validierter Umsetzung.

Positioning

Executive AI & Transformation Leadership for regulated Life Science Organizations

Executive AI & Transformation Leadership für regulierte Life Sciences Organisationen

I help Life Sciences organizations turn regulatory complexity into scalable, compliant and AI-ready digital platforms. My work combines executive accountability, deep regulated-domain expertise and practical implementation leadership.
Ich unterstütze Life-Sciences-Organisationen dabei, regulatorische Komplexität in skalierbare, compliant betriebene und AI-fähige digitale Plattformen zu übersetzen. Mein Ansatz verbindet Executive Accountability, tiefe Domänenexpertise und praktische Umsetzung.
25+

years in Life Sciences, research and enterprise IT

Jahre in Life Sciences, Forschung und Enterprise IT

15+

years Pharma Regulatory IT leadership

Jahre Leadership in Pharma Regulatory IT

6,500+

users in global validated platform landscapes

Nutzer in globalen validierten Plattformlandschaften

AI

from experimentation to governed enterprise deployment

von Experimenten zu Enterprise Deployment mit Governance

Services

Where I create value

Wo ich Wert schaffe

Clear mandates, pragmatic execution, and boardroom-ready governance for complex regulated environments.

Klare Mandate, pragmatische Umsetzung und executive-taugliche Governance für komplexe regulierte Umfelder.

01

Executive Advisory

Senior sparring partner for digital strategy, prioritization and risk-based decision making in regulated Life Sciences.

Senior Sparringspartner für digitale Strategie, Priorisierung und risikobasierte Entscheidungen in regulierten Life Sciences.

  • Digital roadmap and investment logic
  • Executive stakeholder alignment
  • Risk, compliance and business-value framing
  • Digitale Roadmap und Investitionslogik
  • Executive Stakeholder Alignment
  • Risiko-, Compliance- und Business-Value-Framing
02

Transformation Execution

Hands-on leadership for complex platform, carve-out and modernization programs where delivery discipline matters.

Operatives Leadership für komplexe Plattform-, Carve-out- und Modernisierungsprogramme, bei denen Delivery zählt.

  • Program recovery and delivery governance
  • Vendor ecosystem orchestration
  • Stabilization, hypercare and steady-state handover
  • Programm-Recovery und Delivery Governance
  • Orchestrierung des Vendor Ecosystems
  • Stabilisierung, Hypercare und Übergabe in den Regelbetrieb
03

AI Implementation

Move AI from experimentation into compliant enterprise use - with ownership, governance and measurable impact.

AI von Experimenten in compliant betriebene Enterprise-Anwendungen überführen - mit Ownership, Governance und messbarem Nutzen.

  • AI operating models and governance
  • Workflow automation and LLM integration
  • Validation-aware adoption in GxP environments
  • AI Operating Models und Governance
  • Workflow-Automatisierung und LLM-Integration
  • Validierungsbewusste Einführung in GxP-Umgebungen
04

Regulatory / PV Platform Leadership

Deep domain leadership for Regulatory, Pharmacovigilance and Medical platforms, data and operating models.

Tiefe Domänenführung für Regulatory-, Pharmacovigilance- und Medical-Plattformen, Daten und Operating Modele.

  • RIM, submissions, Veeva Vault and data quality
  • PV and Medical platform governance
  • Migration strategy and inspection readiness
  • RIM, Submissions, Veeva Vault und Datenqualität
  • PV- und Medical-Plattform-Governance
  • Migrationsstrategie und Inspection Readiness
Experience

Selected leadership
track record

Ausgewählte
Leadership-Erfahrung

A progression from scientific research to Pharma business & IT consulting, regulatory operations, global enterprise platforms and AI-enabled transformation execution.

Eine Entwicklung von wissenschaftlicher Forschung über Pharma Business & IT Consulting und Regulatory Operations zu globalen Enterprise-Plattformen und AI-gestützter Transformation.

Current
Aktuell

Digital Lead - Regulatory, Pharmacovigilance & Medical IT

Confidential Life Sciences Organization · Carve-out environment
Life Sciences Organisation (vertraulich) · Unternehmens-Carve-out

Executive accountability for regulated digital platforms during organizational separation and stabilization, including target operating model, governance, data migration strategy, vendor orchestration and inspection-ready platform operations.

Executive Accountability für regulierte digitale Plattformen im Rahmen organisatorischer Trennung und Stabilisierung, einschließlich Target Operating Model, Governance, Datenmigrationsstrategie, Vendor-Steuerung und auditfähigem Betrieb.

Founder
Gründer

ICE Digital Ventures - AI Transformation Execution Partner

Independent · Frankfurt / Hybrid
Selbständig · Frankfurt / Hybrid

Partnering with Life Sciences organizations to move from AI experimentation to scaled, validated enterprise deployment - with focus on operating models, governance, workflow integration and compliant system architectures.

Unterstützung von Life-Sciences-Organisationen bei der Überführung von AI-Experimenten in skalierte, validierte Enterprise-Anwendung - mit Fokus auf Operating Modelle, Governance, Workflow-Integration und compliant Systemarchitekturen.

Merck

Head, Veeva Office / Head of GRA Informatics

Merck KGaA, Darmstadt

Led global Veeva Vault and regulatory application landscapes across 6,500+ users, establishing governance frameworks, operating models, data foundations and digital roadmaps for regulated enterprise platforms.

Führung globaler Veeva Vault und Regulatory-Applikationslandschaften für 6.500+ Nutzer, Aufbau von Governance, Operating Modellen, Datenfundamenten und digitalen Roadmaps für regulierte Enterprise-Plattformen.

STADA

Head Regulatory Operations

STADA Arzneimittel

Modernized Regulatory IT systems, led RIMS replacement and eSubmission initiatives, improved data quality and compliance, and shaped organizational development across Regulatory Operations.

Modernisierung regulatorischer IT-Systeme, Leitung von RIMS-Ablösung und eSubmission-Initiativen, Verbesserung von Datenqualität und Compliance sowie Organisationsentwicklung in Regulatory Operations.

Insights

Selected thinking

Ausgewählte Gedanken

Short executive perspectives on AI, governance, regulatory data and transformation in regulated environments.

Kurze Executive-Perspektiven zu AI, Governance, Regulatory Data und Transformation in regulierten Umgebungen.

AI in regulated environments

AI only scales when it fits into validated workflows, data governance and auditable operating models.

Read on LinkedIn

What most AI strategies get wrong

The issue is rarely the model. It is ownership, validation and integration into enterprise platforms.

Read on LinkedIn

Regulatory Affairs as a data function

Regulatory platforms are evolving from document repositories into structured knowledge systems.

Read on LinkedIn
Innovation Lab

Practical experiments, selectively applied

Praktische Experimente, gezielt eingesetzt

Innovation work remains deliberately separated from the executive transformation profile: useful patterns are carried into enterprise contexts, speculative noise is not.

Innovationsarbeit bleibt bewusst vom Executive-Transformation-Profil getrennt: nützliche Muster werden in Enterprise-Kontexte übertragen, spekulatives Rauschen nicht.

Applied AI & automation patterns

Anwendung von AI & Automatisierungsmustern

Exploration of AI-enabled workflows, knowledge extraction, automated reporting and data-driven intelligence models for regulated and adjacent domains.


Exploration von AI-gestützten Workflows, Knowledge Extraktion, automatisiertem Reporting und datengetriebenen Intelligence-Modellen für regulierte und angrenzende Domänen.

LLM WorkflowsKnowledge SystemsAutomationDecision Support

Selective ICE Ventures topics

Ausgewählte ICE Ventures Themen

Early-stage concepts around decentralized science, pharmacovigilance intelligence, market intelligence and AI-generated content operations - used as learning fields, not as the core executive offer.


Frühphasige Konzepte rund um DeSci, Pharmacovigilance Intelligence, Market Intelligence und AI-generierte Content Operations - als Lernfelder, nicht als Kernangebot der Executive-Positionierung.

DeSciPV IntelligenceMarket IntelligenceAI Content Ops

Let’s turn complexity into operating clarity.

Lassen Sie uns Komplexität in operative Klarheit übersetzen.

Available for selected interim, advisory and transformation execution mandates in regulated Life Sciences environments.

Verfügbar für ausgewählte Interim-, Advisory- und Transformationsmandate in regulierten Life-Sciences-Umfeldern.