Stephan Klaschka

Stephan Klaschka helps large organizations change from the inside — with a documented 10x innovation track record, an Ivey case study taught at 42+ business schools, and a forthcoming book, The OrgChanger.

• Build capabilities across Data Management, MDM, Reporting, Advanced Analytics, and AI for products such as DUPIXENT, creating a robust data foundation that powers faster business decisions and actions • Bridging Regeneron's R&D and Commercial departments with onshore/offshore software development team, translating business needs into actionable delivery roadmaps for technical execution • Program rescue to recover workstreams. • Governance architect establishing PMO frameworks, maintaining program plans

Program Manager for Culture of Innovation at America's largest state power organization. • Designed and launched the Eureka! innovation governance program, building ideation-to-execution networks as a delivery platform across the organization • Lead strategic transformation at the Office of Digital Transformation & Innovation in close partnership with the AI & Automation Center of Excellence • Guide innovation strategy, culture & ideation programs from concept through execution across all business functions

• Clinical Operations Transformation at BMS, Alumis, Alladapt, EIKON: led organizational shifts to lean governance models, accelerated speed-to-market while maintaining strict GCP compliance incl. cross-functional workshops across 14 departments to align stakeholders on risk-based management in clinical trial operations • Quality Management System (QMS) overhaul at Roche, BMS, Gilead, Alumis, Sarepta: revamped regulatory frameworks, reduced development lifecycles by 31%, achieved 100% inspection readiness

R&D Project Management and Data Science Feasibility for advanced computing; RWD/RWE; Policy and governance for Cyber-Security, Privacy, and AI at Janssen R&D.

Research-driven leader for predictive workplace analytics (WPA). Supporting aggressive growth targets, I transformed a former consulting firm into a SaaS startup which offers a scientifically validated method for predictive workplace analytics to build trust and manage the remote workforce. Architected SaaS product suite, data models, customer discovery, digital marketing. Set up workplace, operations, logistics, recruiting, HR, payroll, policies, ICT. Developed new accounts and partnerships.

Mentoring corporate entrepreneurship and innovation teams in Global 500 companies (EU/UK/USA) with Design Thinking, Agile and lean startup from successful executive pitches to project execution.

DITG offers evidence-based, telemedical interventions for chronic diseases to reduce healthcare costs. As interim CEO, I turned around a struggling young telehealth firm by stabilizing operations and compliance while meeting the objective of attracting a VC investor as majority shareholder in 6 months.

As a first-of-its-kind staff position central to revenue growth rejuvenation and cost savings, I drove pivotal innovations, competitive advantage, leadership development, emerging technologies (big data, AI, ML, IoT, R&D simulations, organic&conventional 3D-printing) and trend scouting for technological and organizational transformation across the global Boehringer Ingelheim group. - Developed strategic and disruptive digital innovation with behavioral success metrics.

GCP/GxP, CRF 21 Part 11, Computer System Validation, FDA inspections

Business Operations Lead for global system implementation, operation, and user support in clinical development; 70,000+ global user base; lead 4 global teams, 8 direct and 28 indirect reports; $6M budget; Business Process Modelling (BPM), Continuous Process Improvement (CPI).

Oversaw department governing critical systems (clinical trials, statistical analysis, e-submission) for global clinical development and operations in the EMEA region with a $6 million budget. - Grew organization 300%, re-organized into teams to add responsibilities and +180% data volume.

Cutting-edge Management, Innovation, Technology

Project Management

Business Administration