Janna Michaeli ז'אנה מיכאלי Email & Phone Number

Rehovot, Center District, Israel

• Led program management and customer success teams to define project scopes, budgets, and methodologies for customer-facing initiatives.• Managed a proficient and professional support system for business partners, ensuring successful project delivery.• Developed and implemented strategies to enhance customer satisfaction and drive business growth through effective program management.

Israel

project management

Jerusalem Area, Israel

Oversight and product management over the Microbiology, CMC, Toxicology, Preclinical ADME and drug PK, Regulatory & Clinical departments, guiding day-to-day operations & aligning them with company objectives. Worked closely with C-level executives and collaborated with key internal and external cross-functional key stakeholders. I provided oversight for various activities, including pre-clinical studies (PKPD), toxicology, pharmacology, microbiology, clinical advancement, and execution of regulatory affairs activities for an IND submission. I played a pivotal role in leading the company to the successful completion of a safety phase 1 clinical trial. I managed CMC aspects of drug manufacturing, focusing on ensuring API quality, scale-up, yield, and global regulatory compliance. I managed regulatory submissions to the FDA/EMA, worked closely with advisers and legal counsels, and engaged in business operations definition and management.I ensured strict compliance with regulatory guidelines under ICH guidelines, Good Clinical Practices (GCP) and clinical methodologies. I developed the product's pharmaceutical requirements for clinical usage, clinical writing (IB, IMPD, clinical study design & protocol, clinical pharmacokinetics (PK) evaluation design, endpoint definition and data analysis plan) and managed project contracts with all vendors. Moreover, I engaged in business development efforts aimed at enhancing drug development capabilities and driving strategic initiatives for the organization.

High-Tech Village, Givat Ram Campus Jerusalem 91391, Israel

Matrix management of the Toxicology, Pharmacology, non-clinical PK/ADME & RA departments, hands-on & by overseeing global CRO s and CDMO s, ensuring timely delivery of high-quality data & product manufacturing via remote management and on-site troubleshooting under GLP and GMP guidelines.I played a pivotal role in designing protocols, overseeing their execution at worldwide CRO sites, analyzing data, and crafting regulatory-compliant reports in accordance with GLP standards. I led and managed the FDA pre-IND submission and the First-in-Human CTA Phase 1 submission to the EMEA. In product / project management, I conducted extensive research to validate patient needs and regulations through data analytics, in-person meetings with internal/external stakeholders, Key Opinion Leaders (KOLs), physicians, regulatory advisers, and professional consultants. This comprehensive approach allowed me to effectively address diverse aspects of drug development and regulatory compliance.I actively defined and managed risks, established go-no-go criteria, and evaluated project budgets.

Jerusalem

* In-Vivo/In-Vitro/Ex-Vivo Proof-of-Concept (PoC) and efficacy establishment. * Scientific writing, Ethical applications submission for animal studies* Infection animal model development, Survival model, Bacterial burden reduction model, IV IP IN IT SC*Cell biology and Tissue culture (M07): Hematological effects, HEK293T toxicity.*Microbiology (CLSI M100): MIC50/MIC90 clinical isolates, Serial passages, Disc diffusion, Drug candidate selection.*Molecular biology assays: Cytotoxic effect evaluation *Toxicology: non-GLP and GLP IND package studies in rodents and non-rodents* Grant application, definition of project roadmap and budget * Stakeholder engagment * Budget evaluation, timelines, Gantts, operations

Jerusalem, Israel

Jerusalem, Israel.

Department of physiology; Research on the nervous system and the mechanism for chronic pain, using transgenic mice and live tissue cultures of the HSV virus.

Master Of Business Administration - Mba

Master Of Science (M.Sc.Med), Immunology And Cancer Biology

* Responsible for planning, executing, and trouble-shooting laboratory experiments. * Use of molecular and cellular biology as well.

Good Clinical Practice - Gcp, Clinical/Medical Laboratory Science/Research And Allied Professions

Good clinical practice course based on the ICH-GCP, E6 (R2) & the updated Israeli MOH guidelines

Cra, Cta & Crc, Clinical/Medical Laboratory Science/Research And Allied Professions

Master Of Science (M.Sc.), Cellular Immunology Lab.

Summer Internship GIST 2015

Bachelor Of Science (Bsc), Biology, General