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Global Clinical Lead
Apply now »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
Competencies
- Cooperation
- Result-orientation
- Professional skills
- Change management
- Self-development, developing others
Long Description
Long Description