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Global Clinical Lead

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Date: May 27, 2023

Location: Budapest, HU

Company: Richter Gedeon Nyrt.

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The Global Clinical Lead, Biologics reports to the Head of Clinical Development of Richter and is perceived as the right-hand of latter and plays a key role in all scientific and clinical aspects of the development activities of the company in Biologics/Biosimilars.

Long Description

  • Conceptional planning and implementation of clinical development strategies
  • Development and review of clinical strategies and relevant documents e.g., briefing documents for authority interactions
  • Participation in scientific advice meeting, e.g., contribution to the development of relevant briefing documents and presentations
  • Guidance and support in all clinical operational aspects pertaining to planning, start-up and management of clinical Phase I and III trial, such as:
  • Development and review of e.g., study protocol, informed consent, operational study plans, case report forms and documents for regulatory submissions
  • Identification, selection and management of external service provider and CROs
  • Overseeing and regular reporting of study progress to ensure completion within agreed timelines/milestones and budget
  • Interactions with Regulatory Affairs, Drug Supply, Drug Safety and other relevant company functions or external development partners
  • Develop and control agreed study budget in liaison with finance department
  • Development of Standard Operating Procedures (SOPs)
  • Plans and actively contributes to GCP audits and inspections
  • Responsible for filing and maintenance of study/project documents

Long Description

  • At least 10 years in international clinical project management
  • Solid knowledge of Good Clinical Practice (GCP) comprehensive understanding of Clinical Development
  • Strong background in strategic and conceptual planning of – ideally but not exclusively – biosimilars
  • Ability to cover the complete development chain, including discussions with Health Authorities
  • Leadership skills; ability to lead internal project teams as well as external partners
  • A mature, seasoned individual who can infuse the Richter organization with best practices and take an active part in the ongoing culture change of the company
  • A hands-on attitude and a flexible mindset; ability to find quick solutions to problems; agile, resourceful
  • Proficiency in English
  • University degree in the field of Medicine/Pharmacy/Science

Long Description


  • Cooperation
  • Result-orientation
  • Professional skills
  • Change management
  • Self-development, developing others

Long Description

Long Description