Experience

Regenera Pharma

• Israel
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Clinical Development Program Manager

  • Aug 2017 - Present

  * Involved in the development of the study protocol based on scientific knowledge of the developed drug and the related indication* Identify and develop professional relationships with KOLs by engaging in ongoing and balanced scientific exchanges related to ongoing and pipeline projects.* Responsible for gathering feedback and insights from KOLs to to support the clinical development needs and strategy of the company. * Responsible for all operational aspects of a phase 2 Alzheimer's Disease and a phase 3 NAION clinical trials* Oversee and manage all study planning activities, protocol development to study execution including ongoing performance tracking of all metrics and quality indicators* Review and selection of outsourcing providers for clinical trials, monitors and CROs* Organize, participate and scientifically support investigator meetings* Travel for meetings and site visits – training and sites engagement



Regenera Pharma, Ltd.

• Project Manager

  • Jan 2016 - Present

  Involved in cell-based assays development, validation, as well as GMP release and stability testing of the company product.Manage and ensure timely completion and delivery of analytical results and documentation (technical reports, SOPs, IND submissions) to support product development during clinical phases.Promoting innovative translational strategies from preclinical in vitro and/or in vivo models to human clinical research.Assessing the benefits and monitoring the costs and effectiveness of research and development activities. Leading complex research projects, including coordination with CROs, interpretation and analysis of results, provide recommendations based on findings and advice on research and development options available to the company.



BTG A Ferring Company

• Israel
• Biotechnology Research
• 200 - 300 Employee

• Research Scientist

  • Mar 2015 - Jan 2016

  Directly accountable for the design and development of reliable cell-based assays suitable to serve as a test release that meets ICH requirements. A key responsibility in successfully manage day to day CRO interactions including experimental direction, data management and analysis. Contributed as a team member on global CMC biological drug product development team. Directly accountable for the design and development of reliable cell-based assays suitable to serve as a test release that meets ICH requirements. A key responsibility in successfully manage day to day CRO interactions including experimental direction, data management and analysis. Contributed as a team member on global CMC biological drug product development team.



Weizmann Institute of Science

• Post doc

  • Jun 2013 - Jun 2015