Dr. Daria Chestnykh
Preclinical Project Manager @ Navigo Proteins GmbH
About
Project Manager with over 8 years of experience managing preclinical and clinical studies within the pharmaceutical industry. My expertise lies in delivering high-quality, compliant, and timely results by leading cross-functional international teams, optimising processes, and ensuring alignment with regulatory standards (GCP/GLP/ICH, EMEA and FDA Directives). Core Strengths: - Expert in developing preclinical programs, managing preclinical studies, preparation of Module 4 of CTD, with proven success in adhering to timelines, budgets, and quality metrics; - Adept in the administration of clinical trials (Phase I-II), overseeing the preparation of study-related documents, and investigational product logistics in line with the project timeline, budget and scope; - In-depth understanding of EMEA and FDA regulations, GCP/GLP/ICH guidelines, and SOP implementation; - Proactive approach to identifying and mitigating risks in clinical and preclinical studies; - Skilled in uniting CROs, vendors, and stakeholders to achieve shared goals. I am currently looking for new job opportunities and would be excited to bring my expertise to a dynamic team where I can contribute to innovative drug development. Letʼs connect to explore potential collaboration opportunities!
-
Germany
Pharmaceuticals
Agile Methodologies, Regulatory Compliance, Leadership, Effective Communication, Clinical & Medical Research, Stakeholder Engagement, Risk Management, Organization Skills, Problem Solving, Communication, Budget Management, Business Development, Pharmaceuticals, Strategic Thinking, Negotiation, Biologics, ICH, Team Leadership, Biotechnology, Contract Research Organization (CRO)
Experience

Researcher at Human Biology, PhD candidate
Erlangen, Bavaria, Germany
● Managed 8 research projects in psychopharmacology, resulting in the preclinical characterisation of 5 novel pharmaceutical compounds that contributed to cutting-edge treatments for psychiatric disorders ● Designed and conducted 25+ translational experiments, producing comprehensive datasets; analysed, interpreted, and presented findings within cross-functional international teams ● Uncovered a novel mechanism of action for antipsychotic drugs, identifying new sphingolipid targets for pharmacological therapies ● Presented findings at 4 major international conferences, including FENS 2024 and EBPS 2023, and contributed to 5 publications in peer-reviewed journals, building productive collaborations ● Optimised experimental workflows, reducing average study completion time by 20%

Preclinical and Clinical trial manager
St. Petersburg Research Institute of Vaccines and Serums
Saint Petersburg Metropolitan Area
● Coordinated the planning and execution 2 Phase I-II clinical trials (vaccines), achieving 100% regulatory compliance with local and international standards ● Oversaw clinical trial timelines, budgets, and milestones, delivering 100% on-time project execution aligned with company goals ● Managed to prepare and communicate essential clinical trial documents, ensuring seamless operations and logistics for investigational products to CROs and sites ● Improved communication efficiency by 25% through the implementation of new collaboration strategies and tools ● Conducted quality control processes in collaboration with CROs, leading to a 20% reduction in deviations and ensuring 100% GCP/ICH compliance ● Administered planning and execution of preclinical studies for 5 projects (vaccines and diagnostics), fully complied with local and international regulations (GLP/ICH, EMEA guidelines) and secured CTA approval within the projects' scope, timeline and budget

Senior Preclinical Studies Manager
Moscow, Russia
● Developed 10+ preclinical study programs for Originator and Generic drugs (small molecules), ensuring GLP/ICH guidelines compliance within approved timelines, quality standards and budgets, contributing to successful regulatory submissions in a fast-paced environment at national and international level ● Managed 12 complex projects covering CNS, Cough&Cold, Gastroenterology, and Antibacterial therapeutic groups, securing 100% regulatory approvals and clinical trials authorization. ● Collaborated with interdisciplinary teams, such as Project Management, R&D, Clinical Trials, Regulatory Affairs and Marketing, for strategic project development, portfolio and product lifecycle management. ● Proactively identified and escalated potential operational issues with a detail-oriented approach, and implemented accurate evaluation projects and process improvement initiatives, resulting in timely resolution and 100% successful study accomplishments. ● Contributed to cross-functional team meetings in the evaluating of the product portfolio, analysing scientific background for novel indications and therapeutic modalities ● Provided scientific literature reviews, science-based materials and consulting support for multifunctional teams and stakeholders regarding strategic directions and drug development plans.

Preclinical studies manager
Moscow, Russia
● Optimised the timelines and quality of preclinical studies by 30% by initiating collaboration with 10 new EU, USA, China, and Russia research centres and establishing strong relationships with partner CROs and external vendors. ● Enhanced research quality by reviewing and editing Study protocols and reports, and conducting regular Sponsor oversight visits, resulting in a 15% decrease in protocol deviations and a 25% increase in data accuracy. ● Designed, administered and controlled 25+ preclinical studies, including GLP and non-GLP studies, toxicology, pharmacology, pharmacokinetics and early stage proof-of-concept studies, oversaw the preparation of study protocols, amendments, deviations and reports, collaborating with CROs and AROs resulting in smooth approval of Module 4 of CTD. ● Administered planning, execution and tracking of pre-clinical study procedures, including data systems and resource management, within defined timelines, budgets and quality requirements.

Preclinical Studies Coordinator
Moscow, Russia
● Administered invoices and accruals with 100% budget compliance, ensuring financial transparency ● Collaborated with global CROs to develop study-related documents and monitored seamless execution, adhering to GLP standards ● Introduced new sponsor oversight practices, reducing reporting inconsistencies by 10%

Preclinical Study Manager
St Petersburg City, Russia
● Executed in-house preclinical studies for 5 biosimilar insulins, resulting in clinical trial approvals and fulfilment of government contracts ● Evaluated novel therapeutic compounds for strategic alignment with company goals ● Optimised internal laboratory workflows, reducing sample processing times by 15%
Education
Dr. Daria Chestnykh's Contact Information
Phone
Find the Right Leads
Find Verified Contact Data
What LeadContact does well
Find verified emails, phone numbers, and decision-makers with 98% accuracy.
Find Leads
Find the right people by company, role, industry, location, and more.
925M+ professional profiles

Find Emails
Access verified email addresses for your target contacts.
657M+ emails

Find Phone Numbers
Get cross-validated phone data from multiple top sources.
239M+ phone numbers

More Accurate. Lower Cost.
Find contact data in 1 tool with 98% accuracy
LeadContact integrates leading enrichment tools to deliver more accurate contact data—without paying for each one.
Great conversations start with the right contact.
It’s time to find yours.




