Warsaw, Mazowieckie, Poland
CLINICAL DEVELOPMENT OPERATIONS LEADER balancing business goals, effectiveness and efficiency with a focus on people I am a clinical development operations leader with a 23-year career path and a 19-year managerial experience in an international environment on different positions (CRA, Regional Project Manager, CRO Alliance Manager, Business Support & Study Start-Up Leader, Portfolio Support Cluster Co-Lead and Director Global Clinical Trial Safety). In 2020-2021 I had an additional interim role of the Country Head of Clinical Operations in Poland and the Central & Eastern European region. In 2015-2022 I was a Vice President of the Clinical Research Group of the professional society INFARMA (the Polish branch of EFPIA), being involved in different industry-level initiatives on its behalf: i.e. working on the new clinical trial regulation for Poland as a member of a focus group by the Ministry of Health and the Medical Research Agency; the regulatory/ legal/ ethics workstream leader of the project “Good clinical practice of medicinal products during COVID-19 pandemic guidelines”; 2 reports “Industry clinical trials in Poland” (launched in 2016 & 2022). As of 2024 I have continued my career as Senior Director, Head of the Global Clinical Trial Safety Review Centre at AstraZeneca. My key strength is the ability to combine the following competencies: - leading a global organisation - strategic view on clinical development - experience in building a clinical research organisation and its strategy - leading cross-functional teams in a matrix environment - functional management / team management - (agile) project management - technical expertise in several areas of clinical development operations, including clinical data medical review - change management - risk management - business insights and analytics (operational data - KPIs, metrics) - organisational budget management / finance management - outsourcing management / vendor management - people development / coaching / mentoring - living diversity & inclusion as natural values - stakeholder management - networking in a diverse environment and societies - sponsor’s role for global initiatives - using AI/ agentic AI at work
- Accountable for the safety clinical data review process in a therapeutic area of ONCOLOGY in a team of 50+ Clinical Trial Safety Scientists, Senior Clinical Trial Safety Scientists and Associate Directors Clinical Trial Safety Scientists (line management of ~15 direct reports) - Co-leading a Global Clinical Trial Safety Review Center, TRISARC (~95 employees across 2 global locations), constituted by the 3 therapeutic area subunits: ONCOLOGY, R&I/ V&I/ rare diseases, CVRM - Implementing a new strategy for TRISARC and the Oncology Subunit, focused on the extended scope of medical review with the risk-based approach to deliver high quality data with increased efficiency - Contributing to the activity and goals of the larger Clinical Data & Insights organisation - Accountable for oncology portfolio management of the Global Clinical Trial Safety Review Center (TRISARC)
Psychotherapy sessions for individuals (adults & teenagers) and couples
Acting as a university lecturer of postgraduate studies ”Project Management in Clinical Trials”. Sharing expertise in two areas: - building and managing diverse teams - diverse leadership styles
- Co-leading a global Work Product Team focused on business continuity risks associated with a global transformation of clinical operations - Leading a Clinical Operations Business Support team in the Central & Eastern European region (outsourcing & vendor management, resource management, business insights & analytics, finance - clinical study budgets, payments, contracting & legal support for the entire local clinical operations organisation) - Co-leading a Portfolio Support Cluster in clinical operations in Central & Eastern European region - an empowered and self-organising cross-functional team of Clinical Operations Business Support and Quality, Compliance, Process & Training experts
- Leading the regional clinical operations organisation in Poland and the Central & Eastern European region (11 EU countries) - Designing transformation of the operational model in an agile setting (SCRUM framework) and leading the organisation through the change - Additional ad interim responsibility
As a Clinical Operations Business Support & Study Start-Up Leader, I managed a group of 5 team leads (the total size of the team ~30 individuals) being accountable for study start-up, outsourcing & vendor management, resource management, business insights & analytics, finance - clinical study budgets, payments, contracting & legal support in clinical operations in Central & Eastern Europe (11 EU countries).
INFARMA is the Employers’ Union of Innovative Pharmaceutical Companies. INFARMA is a member of the European Federation of the Pharmaceutical Industries and Associations (EFPIA). http://infarma.pl
INFARMA is the Employers’ Union of Innovative Pharmaceutical Companies. INFARMA is a member of the European Federation of the Pharmaceutical Industries and Associations (EFPIA). http://infarma.pl