Dikla Sharon

Key Professional Experience

Feb 2023 - Mar 2024
Micreos Pharmaceuticals AG
Head of Clinical Operations
  • Created comprehensive CDPs for lead candidate products in dermatology and oncology.
  • Set up and planned all ClinOps-related logistics, including vendor selection and management.
  • Liaised with early development, CMC, and pre-clinical teams to ensure seamless integration of clinical strategy.
  • Worked closely with KOLs and advocacy groups through Advisory Boards to shape clinical development strategy.
Jul 2016 - June 2020
Takeda (via acquisition of Shire)
Director, Clinical Programs Team Lead, Hematology
  • Led ClinOps for 8 product lines across 10 indications, managing global studies in over 20 countries.
  • Oversaw budgets up to €100M per program, spanning 5-10 years.
  • Established and developed the Hematology ClinOps team, including recruitment and mentoring.
  • Spearheaded the setup and conduct of gene therapy programs.
  • Developed ClinOps oversight approach for all CROs, enhancing operational efficiency.
  • Supported Shire-Baxalta integration activities, ensuring smooth transition of clinical programs.
Feb 2012 - June 2016
Baxter Innovations, spinoff Baxalta Innovation (acquired by Shire)
Sr. Manager, Clinical Operations Project Lead (CPL), previously Clinical Project Manager (CPM)
  • Led CPM for the company's top priority pivotal phase III study in Hemophilia, securing marketing approval in multiple markets.
  • Represented ClinOps in the integration process of a newly acquired company (SuppreMol).
  • Piloted aspects of a strategic sponsor-CRO partnership (IQVIA), setting new standards for collaboration.
  • Successfully passed multiple regulatory inspections without critical findings.
Sep 2005 - Dec 2011
Cato Research
Clinical Trials Manager; Regulatory Lead for Israel, S. Africa, and EU
  • Managed regulatory and ethics submissions across multiple regions, ensuring compliance with diverse regulatory requirements.
  • Led CPM for the pivotal study of the first FDA-approved drug produced in a plant cell-based expression system (Gaucher disease treatment).
  • Developed expertise in rare diseases and innovative therapies, laying the foundation for future specialization.