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Hello, I'm Tomasz Szelag.
Accomplished clinical operations executive with over 20 years of experience in global pharmaceutical and biotechnology industries. Skilled in building and scaling organizations, leading cross-functional teams, and managing complex clinical development programs. Proven expertise in regulatory compliance, vendor and CRO management, and data-driven process optimization. Experienced in oncology research and clinical trial oversight across Central and Eastern Europe, with a strong record of collaboration with global regulatory authorities, investigators, and executive leadership. Certified Professional Scrum Master and university lecturer, passionate about advancing clinical research, patient advocacy, and leadership development in life sciences.
Details
Professional CategoryConsulting & Advisory
Location
Years of Relevant Experience20+ years
Seniority LevelExecutive
Consulting Rate (Hourly)290
Headline
Clinical Operations, Clinical Development, Clinical Data Management
Experience
Head of Clinical Operations
Relevant/Notable employerRyvu TherapeuticsDecember 2022 - Current• Building and managing the clinical operations department
• Managing functions like Regulatory, Clinical Finance, Data Management, Site Management
and Monitoring, Project Management, Vendor Management, Supply Chain
• Effectively scaling up the organization
• Budget management and oversight (≈ 60M $)
• Acting as program director supporting compound development
• Creating SOPs, processes, policies, and working instruction
• Interacting with investigators, advocacy groups, and regulators (FDA, EMA),
• Very close collaboration with CMO, COO and CEO
Lecturer & External Stakeholders Council Member
Relevant/Notable employerWarsaw University of Life SciencesMay 2022 - CurrentLectures about GCP and clinical trials management for Biology, Biotechnology, Medical
Technology and postgraduate students
• Consultancy in the field of cooperation with business
Director, Study Management
AstraZenecaMay 2021 - September 2022• Study Management Leadership team core member
• Line management to the team covering a global portfolio operationalization
• Operational Management across Study Management
Clinical Operations Leader
Relevant/Notable employerRocheSeptember 2018 - April 2021 leadership and oversight in the delivery of oncology clinical trials in the CEE region (Bosnia,
Croatia, Czech Rep., Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Serbia, Slovakia,
Slovenia) line managing groups of Clinical Study Managers and Clinical Country Specialist
• member of the Regional Leadership Team responsible for building a strategy, managing the
whole organization, implementing the goals, improving risk management, and effective
decision-making
Associate Director Clinical Data Review, Global Data Management
Relevant/Notable employerBristol-Myers SquibbFebruary 2017 - August 2018building the Clinical Data Review department, shaping the organization, recruiting, and hiring
• leading organizations including setting up and monitoring objectives
• line managing a group of Clinical Data Reviewers and Lead Clinical Data Reviewers
• transforming, optimizing, and simplifying processes in data review (less manual work, more
well-programed edit checks, smart listings)
• Led global transformational task forces and initiatives like Optimizing Medical Data Review
and transformation of clinical data management into a centralized data review model
• vendor liaison for clinical data management and clinical trials management
Clinical Operations Manager, Site & Clinical Data Quality Management
Relevant/Notable employerBristol-Myers SquibbOctober 2013 - January 2017development of projects execution strategies and studies deployment solutions in a Central and
Eastern Europe region
• leadership and oversight in the delivery of clinical trials in the CEET region (Czech Rep.,
Estonia, Georgia, Hungary, Latvia, Lithuania, Moldova, Poland, Romania, Russia, and Turkey)
• line managing a group of Clinical Site Managers and Clinical Data Quality Managers
• vendor oversight and partnership (CRO, phase I units, SMOs, Functional Service Providers)
• building a Clinical Site Monitoring team in Hungary
Clinical Trial Manager
Relevant/Notable employerBristol-Myers SquibbJune 2007 - September 2013• execution of clinical trials in Central and Eastern Europe
• project management and coordination of clinical trials activities
• monitoring budget and study payment
• CRO oversight
• CTMS global expert and trainer
Industry
Education
Hospitals and Health Care
Specific Jurisdictions That I'm Qualified In or Can Cover
Poland
Austria
Belgium
Bulgaria
Canada
Croatia
Cyprus
Czech Republic
Denmark
Estonia
Finland
France
Germany
Georgia
Hungary
Iceland
Ireland
Italy
Latvia
Lithuania
Luxembourg
Moldova
Netherlands
North Macedonia
Norway
Portugal
Romania
Serbia
Slovakia
Slovenia
Spain
Sweden
Switzerland
Ukraine
United States
Language(s)
English
Polish
Education
Wroclaw University of Economics
DiplomaFinance Management, Post-Graduate -
Polish Open University
DiplomaOperational Management, Post-Graduate -
Warsaw University
DiplomaMedical Law, Law of Bioethics, Post-Graduate -
Computer Science College in Warsaw
DegreeDatabases -
Warsaw University of Life Science
MastersGenetics and Biotechnology -
Professional Membership / Certification
ICH GCP R3
Your Skills
clinical operationsCTSMclinical data reviewScaling Upbudget and financeClinical Operations LeadershipRegulatory & Compliance ExpertiseVendor & CRO ManagementStrategic Project & Program Management
Professional Interests
AI in clinical traialscompamy expansioncompany growoffshoringClinical Development StrategyOncology Research and InnovationData-Driven Decision Making in Clinical
