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Experience level:
More than 5 years
Education level:
Languages:
Russian: Native
English: C1
As a Portfolio or Project Director I make things happen and make negative outcomes less likely and less expensive
Lead development programs spanning oncology, inflammation, and biodefense across multiple
global partners. Manage integrated CMC, nonclinical, and regulatory workstreams and ensure
alignment with agency expectations.
• Key Responsibilities-
– Lead drug‑development programs from exploratory studies through IND‑enabling phases
across EU, and US.
– Direct cross‑functional teams of up to 15 internal staff and 10-15 CRO/CDMO contributors.
– Manage operational budget (~€500k/year) and contribute to strategic planning for
multi‑million‑euro program investments.
– Oversee nonclinical programs, from design to reporting, ensuring GLP alignment.
– Coordinate global regulatory engagements (pre‑IND, Type C/D, scientific advice, protocol
development meetings).
– Manage selection, contracting, and performance of CROs/CDMOs across multiple regions.
– Expand partnerships with life-science institutions (oncology, radiation, space, regenerative
medicine) securing continued development funding.
• Selected Achievements-
– Delivered multiple IND‑enabling nonclinical studies on schedule and on budget.
– Strengthened investor and institutional support through successful program presentations
and data packages.
– Aligned regulatory strategy for the biodefense asset with US FDA (“Animal Rule” Pathway).
Oversaw a portfolio of concurrent development programs in oncology and radiation indications,
balancing capital allocation, regulatory risk, and resource constraints across multiple assets
and external partners.
• Key Responsibilities •
– Led international development programs with €15M cumulative R&D budgets
(nonclinical, clinical, CMC).
– Managed up to 15 direct reports, plus 10–15 external contributors across
CRO/CDMOs.
– Designed and executed regulatory strategies for EU, US, and Asian markets.
– Led agency interactions (EMA CHMP, FDA CDER/DIRM, DMA, TFDA).
– Oversaw CMC: process development, scale‑up, analytical development/validation, tech
transfer, and GMP batch supply.
– Directed design, construction, and qualification of a small‑scale GMP intermediate facility
(URS, FAT/SAT, IQ/OQ).
– Established and maintained key development documents (TPP, IMPD, IB, SDS, CTD
modules).
– Implemented project‑management systems, document control infrastructure, and
collaboration platforms.
• Key Achievements •
– Delivered multiple Phase I and Phase IIB oncology trials on time and within budget.
– Achieved regulatory alignment of development strategies with EMA and FDA
requirements.
– Brought several drug development regulatory strategies in alignment with the
requirements of the European Medicines Agency and the US Food and Drug
Administration.
– Successfully negotiated and managed a >€7M development contracts for acute radiation
injury therapies.
– Oversaw the launch of kilo‑scale GMP manufacturing of key intermediate and successful
tech transfer for API and FDF to CDMOs in EU and Asia.
– Achieved broad patent protection across 34 countries.
– Led establishment of overseas R&D office (10+ employees) and coordinated interactions
between administrative and scientific teams.
– Built company‑wide collaboration and workflow systems improving transparency,
throughput, and compliance.
Conducted technical and financial evaluations of investment projects.
• Key Contributions •
– Performed analysis (in a team of 2 other analysts) of business operations of a company
funded by the European Bank for Reconstruction and Development (EBRD).
– Performed operational and financial due‑diligence analyses.
– Presented investment cases to senior leadership.
– Promoted rapidly to Project Manager and subsequently recruited as Program Director at
Meabco.
Expert Level
• Management of complex programs and projects in diverse sectors (biotech, green-tech,
microelectronics)
• Drug‑development program leadership (end-to-end: bench → late clinical)
• Budget, time and risk management
Advanced Live
• GxP (GMP, GLP, GCP)
• CMC strategy and execution
• Intellectual Property
• Due diligence and business case evaluation
• Regulatory strategy (EMA, FDA; human drugs, orphan drugs, biodefense, Animal Rule)
• Data analysis and statistics (descriptive, inferential)
Working Knowledge
• Biology, radiation biology, oncology
• Green-technologies
• Micro-electronics: digital signal processing, general processing, computer architectures
Tools & Systems
Microsoft Project, Merlin Project, Gantt and PERT tools, VSM, MindMap/xMind, PMBOK
Trello, Box, Bitrix24, Git, SVN
Microsoft Office Suite, Keynote, Pages, Numbers
GraphPad Prism, R (Statistics/Learning), Mendeley, Zotero