MIT Sloan School of Management

Technische Universität Berlin

Colorado Technical University

Internatsgymnasium Pädagogium (Private Boarding School)

John F. Kennedy School (JFKS), Berlin, Germany

Chief Growth Officer (CGO) at Impetus Digital  -  Strategy Consultant & Innovation Executive at Klaschka & Co

Scimitar is a life sciences-focused management consulting firm that provides strategic industry insights and high-return solutions to clients ranging from healthcare service providers to top biopharma and medical device innovators. We partner with our clients to speed up and solve their most pressing business challenges, so they are equipped to thrive in a complex global environment.

My focus is on Business Strategy/ Clinical/ Quality/ RA/ Compliance/ GRC in Pharmaceutical/ BioTechnology/ Diagnostics/ Medical Devices as well as Program Management, Project Rescue Management, Organizational Effectiveness, and Innovation and Change Management.

Recent bio-pharmaceutical, diagnostics, and medical device client projects with Scimitar included:
- Providing strategic and hands-on guidance for the revamping a corporate division for a large pharma client
- Designing and introducing a lean and practical governance model for priority initiatives for a large diagnostics client
 - Creating a global regulatory compliance database integrated into regulatory operations and the system landscape for a large diagnostics client
- Developing the Strategic Operation Roadmap (3-year horizon), a blueprint to starting a bio-pharma startup!
- Developing workplace analytics and solutions with a research-based, data-driven team trust assessment to measure and improve business outcomes and collaboration
- Operational Strategy Support for a major pharma company
- Building out Quality Management Systems (QMS) in record-time to ensure client inspection-readiness and meet pipeline milestones
- Building a global Regulatory Affairs country requirements application for a major diagnostics enterprise
- Leading a GMP QC maturity initiative for a large biopharma enterprise
- Strategic AI initiatives in Regulatory Affairs
- Chief of Staff / Regulatory Affairs Innovations and Operations

Stephan holds professional certifications including PMI PMP, SCRUM PSM I, SmartSheet Core App and Product.

Scimitar Inc.

Principal | Sr. Consultant

[Klaschka and Co. consulting engagement]
Policy and governance for Cyber-Security, Privacy, and AI at Janssen R&D/Johnson&Johnson. R&D Project Management for RWD/RWE and RCT Data Science Feasibility and Advanced Computing

R&D Compliance and Data Science Excellence: Rescued a pivotal first-of-its-kind RWD/RWE platform project to protect a $10M investment for Data Science in R&D/IT Advanced Computing at Janssen R&D/ Johnson&Johnson by exercising leadership and quality emphasis to overcome regulatory compliance obstacles. Stepped in as Senior R&D Project Manager and compliance trouble-shooter to validate and implement first Data Science RWD/RWE platform.

Johnson & Johnson

R&D GRC Governance and Policy Advisor, R&D IT Project Management | Senior Consultant

[Klaschka and Co. consulting engagement]
Impetus Digital is a leader in the way pharma companies interact and seek advice from key opinion leaders by offering comprehensive, customized professional services and online tools.

In my role as the CHIEF GROWTH OFFICER:
Guided this rapidly growing digital services company through the development of
new strategies (market, product, sales, people) while exploring new revenue streams; e.g, DaaS, IaaS, SaaS, PaaS.

In my role as the CHIEF INFORMATION OFFICER:
Restructured and focused the IT functions technology, provided hands-on leadership and coaching with hands-on to stabilize operations and the delivery of products and services to internal and external clients.

In my role as the GRC OFFICER:
Analyzed overall compliance, identified shortcomings and raised concerns, organized and managed the regulatory compliance function with proper processes and documentation.

Impetus Digital

Chief Growth Officer & Chief Information Officer & GRC Officer | Strategy & Growth Consultant

[Klaschka and Co. consulting engagement]
RegASK is a SPRIM venture-backed portfolio firm delivering B2B digitally-augmented (AI, ML, NLP) 'RegTech' (Regulatory Technology) compliance services for product expansions in foreign markets (APAC, EU, MENA,LATAM) for CPG, FMCG, food and beverages, cosmetics, healthcare, pharma, and medical devices clients.

In my role as a CONSULTANT:
- Spearheading and design new digital, SaaS products, SaaS business models
- Developing and implementing the new digital product strategy

In my role as the CHIEF OPERATING OFFICER (COO):
- Business development, customer discovery, partnerships, digital marketing, UX/UI, branding
- Conducting and supervising company operations worldwide with full P&L accountability

RegASK™

Chief Operating Officer (COO) | Strategy & Growth Consultant

[Klaschka and Co. consulting engagement 6 months, extended to hire]
Transformed a legacy consulting business into a B2B PE-backed SaaS startup for predictive workplace analytics (WPA) to build trust and collaboration for effective remote team management.

In my role as a CONSULTANT:
-	Developed competitive strategies, designed SaaS product, UX/UI, branding, digital marketing.

In my role as the CHIEF OPERATING OFFICER (COO):
-	Set up a new workplace incl. operations, logistics, recruiting, HR, policies, ICT.
-	Developed new products, digital delivery platform, business partnerships & business development

Virtual Distance International

Turned this telehealth company around within 6 months as the interim CEO growing revenue 360% by expanding markets, attracted VC, stabilized operations, processes, technology, and compliance while developing next-generation SaaS products suite.

German Institute for Telemedicine and Health Promotion (DITG GmbH)

Chief Executive Officer (CEO interim) | GmbH Geschäftsführer (Germany)

In this first-of-its-kind staff position central to cross-functional revenue growth rejuvenation in ‘white space’, I transformed the global Boehringer Ingelheim organization with pivotal innovations frameworks for competitive advantage, leadership development, ‘blue ocean’ external innovations, and emerging digital technologies (big data, AI, IoT, R&D simulations, organic 3D-printing) based on behavioral metrics, Design Thinking, Lean Startup, VC and Change Management methodologies.
First-of-its-kind staff position central to revenue growth rejuvenation strategy. Driving pivotal innovations, leadership development, digital transformation portfolio, and products 'beyond the pill' across the Boehringer Ingelheim group worldwide.

Boehringer Ingelheim

Director, Global Innovation Management and Strategy

Founder of Klaschka & Co. (www.Klaschka.co)
•	Driving B2B digital transformation and turnaround, recurring revenue models, new business growth and development, regulatory compliance, new business growth, strategic B2A/B2B partnerships - from strategy to implementation
•	Executive leadership in roles such as CEO, CIO, CSO, CCO, COO, GRC, Director, Board member
•	Project, portfolio, and program management (PMP certified since 2008)
•	Training corporate innovation teams at Global 500 companies (EU/UK/USA), mentoring technology startups (usually PE or VC backed) 
•	U.S. market entry and business expansion for European companies - Business Analysis, Competitive Research, Customer Discovery, New Business Model, SaaS, Implementation
•	Leading digital health innovation in converging industries with emerging technologies such as predictive analytics, AI, ML, NLP, SaaS, IoT, medical devices
•	Remote work and virtual team innovator
•	Academic guest lecturer for innovation and intrapreneurship in America, Europe, Asia, MENA

CLIENTS:
•	ACILIUS, Acrontum, Allstate, AXA, Bayer, BOSCH, DAIMLER, Eularis, Fable+, GERENWA, German Inst. for Telemedicine (DITG), German-American Chamber of Commerce NY, Guerbet, Impetus Healthcare, Janssen R&D, Johnson & Johnson, RegASK, SARYA, Scimitar, Virtual Distance International, Witt Manufacturing Consulting.

RECENT ROLES:
•	Sr GRC Consultant, R&D IT Project Manager at Janssen R&D/Johnson&Johnson, USA, 2021
•	Chief Growth Officer (CGO), CIO, GRC Officer at Impetus Healthcare, Canada, 2021
•	Business Research and Strategy Consultant at Acrontum GmbH, Germany, 2019-2020
•	Chief Operating Officer (COO) at RegASK (a SPRIM company), USA/Singapore, 2019
•	Chief Operating Officer (COO) at Virtual Distance International, USA, 2017-2018
•	Business Innovation and Strategy Consultant at Daimler, Germany, 2017
•	Program Director and Innovation Trainer at Bayer, USA/UK/Germany, 2016–2017
•	Chief Executive Officer (CEO interim) at DITG GmbH, Germany, 2015

Klaschka & Co

Innovation Executive | Digital Strategy Consultant

iQuit! Productions LLC is an independent motion picture production, and film financing company in the greater New York City area. We create film and television projects that cross the boundaries of cultural and race bringing our world closer together through the moving picture.

iQuit! Productions LLC

Managing Partner & Co-Founder

Trusted advisor to CEO, CIO, CFO, Diversity&Inclusion, R&D, Medical, HR, PMOs, Business Development & Licensing and Board-commissioned confidential investigator.

C-Level Advisor, Change and Organizational Effectiveness

Safeguarded CSV, regulatory compliance and inspection readiness with proactive GCP and 21 CFR, Part11 inspection readiness management that prevented any serious findings during regulatory inspections.
-	Proactively managed FDA inspections preventing significant findings across the Medicine Division.
-	Harmonized effective quality assurance, implemented multi-site incl. policies, SOP, CAPA, ICH, GCP.
-	Expert contributor to developing international quality standards initiatives (MedDRA, ICH, HL7).
-	Co-authored the Drug Information Association's (DIA) quality guideline ‘Computerized Systems in Clinical Research, Current Data Quality and Data Integrity Concepts’ (PEACH guideline).

Regulatory Compliance Officer, Medicine Division

Directed implementation, operations, and customer support, and exercised governance for critical computer systems in global clinical development serving 70.000+ users worldwide. Rapidly promoted: Associate Director, Senior Associate Director, Director, and tasked with additional responsibilities.
Contributed to Rx market approvals incl. Pradaxa®, Spiriva®, Ondero®, Aptivus®, Cymbalta®, Tradjenta®.

Director, Head of Clinical Applications Support, North & South America Region

Oversaw teams operating critical systems (clinical trials, statistical analysis, e-submission) in the EMEA region with a $6 million technology budget, grew organization 300%, re-organized teams adding responsibilities and handling +180% data volume.

Head of Regional Data Center, Europe & Africa region

Automated and sped up processes for setting up clinical trial program databases, SAS-based statistical analysis, and regulatory submissions in Corporate Biometry function supporting all business units globally. Directly contributed to market approval for Yaz®, Yasmin®, Gadovist®, and other Rx products. Introduced first GCP and computer system validation system to meet new 21 CFR, Part 11, requirements.

Bayer Schering Pharma AG (Schering AG)

Software Developer | Statistician Assistant

Commercial software development; statistics, data analytics for research projects European Union (EU), European universities, German regulatory agency (BGA, BIfArM), GLP industry groups (IDF, VMW). 
-	Eight commercial software licenses (databases, statistical QA, GLP), international trademark, nine professional publications.

Stephan Klaschka Software & Verlag

Software Developer | IT Consultant | Publisher | Entrepreneur

School of Veterinary Medicine, Institute for Biometry: Foundational statistics lectures, epidemiology research projects, statistical analyses for Ph.D. theses candidates, scientific research projects, and academic publications.

Freie Universität Berlin

Scientific Assistant | Statistics Lecturer | Consultant

University Hospital ‘Benjamin Franklin’ (former Klinikum Steglitz), Medical Information Department: 	Evaluated large hospital database systems, programmed interfaces across OS platforms, implemented new hardware.

Medical Informatics Programmer

University Hospital ‘Benjamin Franklin’ (former Klinikum Steglitz), Medical Information Department