Global Clinical Lead

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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

Long Description

Long Description