Dmytro Gladun
Clinical Research Manager
Gdansk,22
Summary
Strategic Clinical Research Leader with a PhD in Biochemistry and an Executive MBA (in progress), offering over 7 years of experience in clinical development, regulatory affairs, and pharmaceutical innovation. Proven track record in leading cross-functional teams, driving global clinical strategies, and implementing AI-driven solutions to accelerate drug development. Passionate about delivering patient centric therapies and achieving market access on a global scale, with a focus on operational excellence and regulatory compliance.
Clinical research professional with comprehensive expertise in study design, data analysis, and regulatory compliance. Strong collaborator, adaptable to changing needs, and reliable in achieving project outcomes. Expertise in protocol development, patient recruitment, and quality assurance, combined with results-driven mindset. Valued for analytical skills, effective communication, and problem-solving abilities.
Overview
7
7
years of professional experience
12
12
years of post-secondary education
5
5
Languages
Work History
Clinical Research Expert
Polpharma Group B.V.
06.2022 - Current
- Spearheaded clinical research strategy for a leading biopharmaceutical firm, overseeing CRO operations and achieving a 15% increase in trial efficiency.
- Led cross-functional teams to develop ICH/GCP-compliant clinical programs, ensuring global regulatory alignment.
- Implemented AI-driven tools to optimize data analysis, enhancing decision-making for trial design and market access.
- Partnered with senior leadership to secure market approval for new therapies, driving business growth in the EU market.
- Represented the company in global scientific forums, strengthening stakeholder relationships.
Site Manager/IDM
Johnson & Johnson
06.2021 - 09.2022
- Directed clinical trial operations across 10+ global sites, ensuring 100% compliance with ICH guidelines and reducing setup time by 10%.
- Developed and executed site selection strategies, aligning with J&J's global clinical development goals.
- Collaborated with regulatory teams to prepare documentation for international submissions, supporting market expansion.
- Mentored junior team members, fostering a culture of operational excellence and innovation.
Head of Regulatory Affairs Expert Group
Pharmaceutical Company Darnitsa
02.2021 - 10.2021
- Led a regulatory affairs team, achieving a 95% compliance rate across all submissions and expediting market approvals.
- Developed business cases for new pharmaceutical products, securing strategic partnerships for market entry.
- Engaged with global regulatory bodies to ensure alignment with international standards, enhancing organizational credibility.
- Provided strategic oversight for dossier preparation, ensuring readiness for global audits.
Clinical Trials Expert & Regulatory Affairs Support
07.2020 - 02.2021
- Supported global clinical trial strategies, improving operational efficiency by 12% through metrics-driven insights.
- Advised senior leadership on regulatory compliance, ensuring adherence to GCP standards.
- Facilitated cross-functional collaboration to streamline trial processes and documentation.
Regulatory Affairs Manager
Kusum Group of Companies
09.2018 - 07.2020
- Oversaw regulatory affairs for biopharmaceutical products, securing approvals in multiple international markets.
- Built strategic partnerships with clinical sites, enhancing trial execution and compliance.
- Developed regulatory strategies that supported global product launches, contributing to a 20% increase in market presence.
Education
Executive MBA Candidate - Global Business Strategy, Pharmaceutical Market Access, Leadership
Prague University of Economics and Business (Vysoká škola ekonomická v Praze)
09.2023 - Current
PhD - Biochemistry
Taras Shevchenko National University of Kyiv
Kyiv 01.2014 - 01.2017
Master's Degree in Management (MM) - Project Management, Investment Analysis
National University of Life and Environmental Sciences of Ukraine
09.2020 - 06.2021
Master's Degree - Biochemistry
Taras Shevchenko National University of Kyiv
01.2012 - 01.2014
Bachelor's Degree - Biology
Taras Shevchenko National University of Kyiv
01.2008 - 01.2012
Skills
- Clinical Development Strategy
- Cross-Functional Team Leadership
- Strategic Planning & Execution
- Operational Excellence & Metrics Analysis
- Biotechnology & Biopharmaceutical Innovation
- Project & Investment Management
Clinical trial management
Site monitoring
Protocol development
Clinical data interpretation
Key Leadership Competencies
- Clinical Development Strategy
- Global Regulatory Affairs (ICH, GCP Compliance)
- Cross-Functional Team Leadership
- Strategic Planning & Execution
- Data-Driven Decision Making & AI Integration
- Pharmaceutical Market Access
- Stakeholder Engagement (C-Level, Regulatory Bodies)
- Business Case Development
- Operational Excellence & Metrics Analysis
- Biotechnology & Biopharmaceutical Innovation
- Project & Investment Management
Running, basketball
Running, basketball
Timeline
Executive MBA Candidate - Global Business Strategy, Pharmaceutical Market Access, Leadership
Prague University of Economics and Business (Vysoká škola ekonomická v Praze)
09.2023 - Current
Clinical Research Expert
Polpharma Group B.V.
06.2022 - Current
Site Manager/IDM
Johnson & Johnson
06.2021 - 09.2022
Head of Regulatory Affairs Expert Group
Pharmaceutical Company Darnitsa
02.2021 - 10.2021
Master's Degree in Management (MM) - Project Management, Investment Analysis
National University of Life and Environmental Sciences of Ukraine
09.2020 - 06.2021
Clinical Trials Expert & Regulatory Affairs Support
07.2020 - 02.2021
Regulatory Affairs Manager
Kusum Group of Companies
09.2018 - 07.2020
PhD - Biochemistry
Taras Shevchenko National University of Kyiv
01.2014 - 01.2017
Master's Degree - Biochemistry
Taras Shevchenko National University of Kyiv
01.2012 - 01.2014
Bachelor's Degree - Biology
Taras Shevchenko National University of Kyiv
01.2008 - 01.2012
Similar Profiles
GULNURA ABENGULNURA ABEN
Junior product manager at LLP “SANTO Member of Polpharma Group”Junior product manager at LLP “SANTO Member of Polpharma Group”
Barbara WittrichBarbara Wittrich
Team Leader Accounts Payable at Polpharma BiologicsTeam Leader Accounts Payable at Polpharma Biologics
Piotr KoryckiPiotr Korycki
President of the Management Board at Polpharma BiologicsPresident of the Management Board at Polpharma Biologics
Andrei IvanouAndrei Ivanou
CEO at ScrapeitCEO at Scrapeit
Tomasz SiatkowskiTomasz Siatkowski
Freelance Photographer at Self-employeedFreelance Photographer at Self-employeed