An experienced R&D Manager and Immunologist with a proven track record in accelerating drug development from epidemiology to clinical stages, showcasing leadership in multidisciplinary project teams and external partnerships.
Possesses 18 years of industry experience in vaccines and immunotherapies, with extensive expertise in managing R&D pre-clinical research teams and cross-functional project management, ensuring quality management systems compliance.
Demonstrates proficiency in immune assays development, biomarkers, and immune monitoring strategies, with strong scientific, regulatory, and epidemiology literacy, and a commitment to innovation and collaboration with CROs.
Led the establishment of a new department focused on biomarkers and translational research, implementing advanced technology platforms and ensuring translational relevancy from preclinical to clinical development.
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Overview
- Availability
- Asap, full-time, onsite & remote
- Qualification
- PhD in Neuroimmunology, MSc in Biology
- Language Skills
- Romanian (Native), English (Business Fluent), French (Advanced)
- Relevant Expertise
- R&D Manager, Pre-Clinical, Clinical, Immunogenicity, Proof-ofConcept, Assays, Biomarker, Translational Sciences, Oncology, Immunology, Vaccines, Pharma, Biotech
Key-Facts
Extract from previous activities
Biotech Start-Up Company
Interim Head of Biomarkers and Translational Medicine
Established and lead a new department focused on biomarkers and translational research
Recruited experts of different backgrounds from statisticians/bioinformaticians to molecular biologists to strengthen the department
Implemented advanced technology platforms like singlecell transcriptomics
Evaluated phase I and phase II clinical trial samples using single-cell transcriptomics and 10X Genomics platform
Ensured translational relevancy from preclinical to clinical development interacting transversally with key actors as a member of project teams and the R&D management team
Presenter and/or panelist at several scientific conferences
Biotech Company
Associate Principal Investigator
Developed assays for the detection of drug-neutralizing antibodies (NAb assays)
Conducted PK analysis of clinical trial samples
Planned and executed bioanalytical studies following GLP, GCP, and GMP
Served as a contact person for clients and supervised lab staff
Biotech Company
Independent Advisor, Vaccines and Biologics
Provided scientific consultancy for vaccines and biologics business units
Collaborated on innovation, screening, preclinical and clinical research, product life cycle, resource allocation, and productivity KPIs
Authored scientific articles in collaboration with partners and clients
Biotech Company
Interim Clinical Research Lead, Human Immunology
Led a joint research team studying biomarkers of health and immune senescence in elderly subjects
Proposed new research concepts and hypotheses as framework for flu transcriptomic data analyses and interpretation
Achieved cross-functional team cohesiveness through common vision, connecting people, and collaborative behaviors, resulting in completion of clinical program milestones
Evaluated academic opportunities and approved research proposals based on evolving business needs
Spearheaded the formation of a center of excellence in system biology and big data analyses
Published scientific articles and increased departmental awareness and skills on data science and omics