Israel
Pharmaceutical scientist, executive and program manager with 15+ years of end‑to‑end drug development experience, including four programs advanced through IND and into clinical trials in the US, EU, UK and Israel. I specialize in assay development and program design for novel biologics and advanced modalities with limited regulatory precedent. I have led multidisciplinary teams of 20+ scientists and partnered with C‑level leadership on R&D strategy, opportunity prioritization and major organizational decisions. I have also managed external programs with global pharma partners, translating complex science into execution plans that accelerate time‑to‑clinic and create business value. I now offer independent scientific consulting services to pharmaceutical, biotechnology, medical device, and diagnostics companies at all stages of development — working globally across the US, EU, UK, and beyond. My consulting practice covers analytical and bioanalytical method development and validation, clinical sample collection strategy, lab vendor qualification and management, CMC regulatory submissions (FDA INDs, EMA CTAs), clinical program leadership and business development support. 🌎 Serving clients globally 🌎 🌐 https://edithkario.netlify.app/
Scientific consulting for pharma, biotech, medical device, and diagnostics companies across all stages of preclinical and clinical development, working globally with clients in the US, EU, UK, Israel, and beyond. Services include analytical and bioanalytical method development and validation, clinical sample collection strategy, lab vendor qualification and management, CMC regulatory submissions, clinical program leadership and business development support. Experienced with global regulatory authorities including FDA, EMA, MHRA, and the Israeli Ministry of Health. 🌐 Full details: https://edithkario.netlify.app/
⇢ Led the Diabetic Foot Osteomyelitis program end-to-end, including TPP definition, cross-functional planning, risk management, and budget/timeline ownership, while reporting progress and strategic recommendations to C‑level leadership. ⇢ Served on the executive leadership team, partnering with the CEO and CDO on portfolio strategy, platform vision, indication selection, and funding approaches, and representing the company at scientific conferences and industry forums (oral presentations and posters). ⇢ Managed a team across Israel and the US, providing global remote leadership and coordination overseeing drug development activities from target validation and preclinical work through clinical study design, conduct, and data analysis, and ensuring scientific quality, resourcing, and timelines across internal teams and external collaborators. ⇢ Set up and managed over 10 external laboratory vendors for GMP release testing and clinical sample analysis across the US, EU and Israel, covering selection, contract scoping, tech transfer, validation and on‑site scientific and QA audits. Laboratory types included academic, clinical and commercial facilities certified to ISO15189, CLIA/CAP and GMP standards. ⇢ Collaborated closely with R&D units, CMC, QA, QC, Regulatory Affairs, and Clinical teams to align scientific, operational, and compliance priorities across programs.
⇢ Contributed to the Cystic Fibrosis (CF) and Atopic Dermatitis programs from discovery through development, managing a 20-person multidisciplinary team including two team leaders. ⇢ Established, validated and standardized clinical sample collection, processing, storage and testing workflows, and built a bioanalytical assay platform to support DS/DP‑linked PK/PD, biomarker and mechanism‑of‑action readouts in clinical trials. ⇢ Authored scientific content of regulatory submissions and interactions with FDA, EMA, MHRA, and MOH (pre-IND/IND, type C meetings). ⇢ Managed external client programs, including: 🌍 Boehringer Ingelheim - identification of biomarkers associated with patient phenotypes in IBD 🌏 Maruho Co. Ltd - clinical testing of a topical phage candidate targeting S. aureus in atopic dermatitis patients in Japan.
⇢ Contributed to the Acne and IBD therapeutic programs, supporting both discovery and development activities. ⇢ Built and led a multidisciplinary team of BSc–PhD scientists spanning molecular biology, clinical microbiology, and functional cell-based assays. ⇢ Established the company’s central bank of phages, bacteria, and clinical samples, positioning it as a core strategic asset. ⇢ Set up a platform for analytical assays covering development, qualification, and release testing of DS, DP, and production cell banks, including lab infrastructure, staff training, and QA-supported implementation for in-house testing. ⇢ Designed and executed target-validation assays to evaluate potential bacterial strain targets directly in human clinical samples.
⇢ Led a team of 15 BSc–PhD level scientists, including team leaders, with full responsibility for mentoring, performance management, and scientific direction. ⇢ Established a microbiology laboratory for environmental sample processing, microbial isolation, creation of an isolates bank, and large-scale production to test growth enhancers in target crops and anti‑pesticide candidates in greenhouse models. ⇢ Designed and implemented CRISPR/RNP-based methods for efficient non‑GMO genome editing in soybean. ⇢ Developed a pipeline of biochemical assays for high-throughput screening within the herbicide discovery program, supporting target discovery, validation, and hit selection through in vitro enzymatic and binding assays.
⇢ Led a team of 5 BSc–PhD level scientists, providing day-to-day guidance, mentoring, and performance oversight. ⇢ Improved main pipeline efficiency, achieving ~30% reduction in project costs and timelines through method optimization, effective resource allocation, and bottleneck removal. ⇢ Established a broad range of DNA and RNA NGS methods from diverse plant tissues, supporting multiple discovery and validation workflows. ⇢ Developed and optimized model and target plant vectors and assays for high-throughput gene expression and localization (RNA and protein), gene stacks, promoter analysis, and inducible expression systems. ⇢ Collaborated closely with cross-functional teams, including computational biology, plant tissue culture, greenhouse operations, and multiple business divisions.
⇢ Developed high-throughput molecular methods for SNP genotyping in wheat, despite the absence of a reference genome at the time and the complexity of its hexaploid (six-copy) genome structure. ⇢ Established and implemented NGS-based sequencing workflows to support large-scale genetic analysis in wheat. ⇢ Led a TILLING-based wheat breeding project for Bayer CropScience, sequencing ~200,000 SNPs across hundreds of wheat cultivars to identify and prioritize beneficial traits.
@ Prof. Ami Navon's lab, the Department of Biological Regulation.