Pharmtheon Project Manager (Technology Transfer)

• Jan 2023 - Present

Clinical Project Manager (Clinical Dept.)

• Jan 2022 - Dec 2022

Clinical Trials (Phase I) Management- • Preparation of: CTA / Study Protocol / Study Design / the whole Study Package (SDF / CDF / IMP Dispensing Protocol, …) • Communication with: CT Sponsors / Local Regulatory Authorities (SUKL) / Local Ethical Committee / different departments within the company • Manage and lead the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements • Manage and lead cross-functional study teams, including vendors; liaise with other functional areas in order to accurately coordinate clinical study activities • Coordinate clinical study timelines with Project management to meet critical milestones; escalate issues that may jeopardize timelines and deliverables. Conduct study monitoring visits and co-monitoring visits as needed. Provide regular updates of study progression to Clinical Lead, Program Management, and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues • Show less

Pharmacology Scientist (Preclinical Develop., ADC team): Contract Specialist/ADC Programs Management

• Sep 2020 - Nov 2021

• Contributing to the Preclinical Development of Antibody-Drug Conjugates (ADC) as next generation of potent immunotherapies for patients with cancer: from the target selection, antibody validation, ADC conjugation to Investigational New Drug (IND) Application preparation• Management of complex, global, multi-center preclinical research projects in the pharmacology area• Acting as a Single Point of Contact (SPOC) between Contract Research Organizations (CROs) and SOTIO's Legal, Finance, IP departments• Maintaining continuous communication with different divisions at SOTIO• Communicating directly with the Collaborators (Academia/Industry) or CROs in various countries, negotiating contracts for Preclinical Pharmacology Drug safety/Efficacy/Toxicology studies• Contract preparation: Contract review and contract content approvals coordination, signature process initiation, and monitoring (ink, electronic)• Responsible to ensure best contractual Terms & Conditions apply for SOTIO• Post signature contract management, monitoring, and identification of expiring contracts, initiating the process for contract extension or competitive bidding. Show less

Pharmacology Scientist (Preclinical Development, ADC team): SOT107 ADC Program Management

• Dec 2019 - Aug 2020

Biological unit manager

• Jan 2019 - Nov 2019

• Generating external revenue• Building relationships with external stakeholders (from Academia/Industry)• Managing and organizing the biological unit• Assisting in implementing processes and control mechanisms to ensure compliance with regulations and company policies.• Proactively seeking new opportunities within the project scope.• Contributing to the innovation pipeline/portfolio with ideas for the conversion of scientific insight.• Responsible for completing technical reports/presentations of various R&D activitiesSkills:• Proven success in leading projects, ability to coordinate and work with research team members• Outstanding critical thinking abilities that can be applied from various perspectives• Process, task and detail oriented• Applying logical approaches to solve problems• Successful in writing grant proposals and reports• Long track of mentoring and leadership experience• Exceptional conversational, presentation and documentation skills• Ability to learn on the fly and to perform under time pressure• Expertise in molecular biology and genetics, including research techniques required for these fields• Proficient in both “wet lab” (bench) as well as “dry lab” (in silico analysis) techniques, experimental design and data analysis• Excellent publication record Show less

Research And Development (R&D) Specialist

• Sep 2017 - Dec 2018

• Setting up the new biological division (including laboratories) • Assisting in existing toll manufacturing initiatives• Building relationships with external stakeholders from Academia• Responsible for completing technical reports/presentations of various R&D activities• Constantly building on the scientific knowledge, keeping up with literature and field of specialization as well as proactively seeking new opportunities within the project scope.• Managing and organizing the in vitro testing of recombinant proteins produced in the company• Daily supervisor of one technician Show less

Marie Curie Postdoctoral Fellow (Parkos-Nusrat lab.)

• Jun 2015 - May 2017

• Independently managing and organising personal Marie Curie Postdoctoral Fellowship Grant • Completing scientific research reports/presentations • Setting collaborations within and outside the Department of Pathology • Planning and executing in vivo and in vitro experiments. Skills • the state-of-the-art in vivo and in vitro experiments • Project management • Specific certification within the Program for Education and Evaluation in Responsible Research and Scholarship (PEERRS) training (#Conflict of Interest; #Foundations of Good Research Practices (Certification); #Research Administration (Certification); #Subjects Biomedical & Health Sciences (Certification)) Show less

PhD student (Immunogenetics group, Prof. Cisca Wijmenga)

• Nov 2010 - May 2015

• Organization of sample collection, project collaboration and data analysis for a multidisciplinary research group • Leader of two technicians on three different projects • Daily supervisor of 1 top-Master student (5 months internship) • Bioinformatic training and mentorship of visiting MD senior scientist Skills • Generating external revenue (Research grant from J.K. de Cock Foundation, Amsterdam, the Netherlands) • Performing state-of-the-art ‘wet lab’ approaches (FACS, next-generation sequencing preparation (NGS)) • Developing DNA and RNA-expression based protocols, as well as in vitro functional experiments for studying non-coding variants and non-coding RNAs (lncRNAs, lincRNAs) • Performing in silico “big data” analyses (GWAS, RNA-seq, microarrays) • In silico functional annotation and predictions of non-coding variants Show less

PhD student at Groningen University Institute for Drug Exploration (GUIDE)

• Nov 2010 - May 2015

PhD student & Research Assistant (Izakovicova Holla lab.)

• Sep 2007 - Oct 2010

Faculty of Medicine Dept. of Pathophysiology Lydie Izakovicova Holla's group Genetics of complex diseases (periodontitis, asthma, allergic disorders) Responsibilities • Generating external revenue/successful grant writing • Laboratory mentor of nine undergraduate/MD-PhD students • Lecturer of practical courses for 3rd-year medical students (in English/Czech) Skills • Techniques of molecular biology • Lab manager duties (2008-2010) Faculty of Medicine Dept. of Pathophysiology Lydie Izakovicova Holla's group Genetics of complex diseases (periodontitis, asthma, allergic disorders) Responsibilities • Generating external revenue/successful grant writing • Laboratory mentor of nine undergraduate/MD-PhD students • Lecturer of practical courses for 3rd-year medical students (in English/Czech) Skills • Techniques of molecular biology • Lab manager duties (2008-2010)

Visiting Researcher (Cuppen lab.)

• Jun 2010 - Aug 2010

CENTRE FOR MOLECULAR MEDICINE Section Genetics Edwin Cuppen's Group Supervisor: Wigard Kloosterman Responsibilities • Developing high throughput protocol for SOLiD next-generation DNA sequencing • This protocol was implemented in the diagnostic routine at University Medical Center Utrecht (UMCU), Utrecht Skills • Developing high throughput protocols • Molecular biology techniques • SOLiD next-generation sequencing (NGS) • Independent thinking • Project management Show less

Internship (Izakovicova Holla lab.)

• 2006 - Jun 2007

Faculty of Medicine, Dept. of Pathophysiology Theme: Genetics of allergic diseases Techniques of molecular biology Faculty of Medicine, Dept. of Pathophysiology Theme: Genetics of allergic diseases Techniques of molecular biology

Internship (Matalova lab.)

• 2005 - 2006

Institute of Animal Physiology and Genetics Laboratory of Genetics and Embryology Eva Matalova's group Theme: Apoptosis in the formation of the embryonic mouse limbs Histology and histological techniques, laser capture microdissection (LCM), immunohistochemistry (TUNEL,..), ex vivo cultures- embryonic mouse limbs Institute of Animal Physiology and Genetics Laboratory of Genetics and Embryology Eva Matalova's group Theme: Apoptosis in the formation of the embryonic mouse limbs Histology and histological techniques, laser capture microdissection (LCM), immunohistochemistry (TUNEL,..), ex vivo cultures- embryonic mouse limbs