Your Key Responsibilities
Your responsibilities include, but not limited to:
- Evaluate appropriateness of clinical development programs or dossiers offered by partner companies (due diligence = DD): evaluate and review available clinical data (including bioanalytical data, in-vitro studies and dissolution data), prepare dossier assessment summaries for BD and regulatory team including project related risks and proposed risk mitigation strategies
- Provide scientific and regulatory advice to BD and partner companies as needed to correct the gaps or minimize the risks identified
- Provide inputs to BD with budget planning and contract negotiations for in-licensing deals
- Collaborate and interface with BD and regulatory teams to support responses on deficiency letters during regulatory procedures
- Develop clinical strategies for countries in scope and keep overview of ongoing and planned clinical activities
- Support local clinical teams with scientific inputs and guidance for execution of clinical studies for BD products
- Collaboration with wider clinical development community. Collaboration on global clinical initiatives. Responsibility for personal and professional development
- Other tasks determined during the annual objectives setting process and by KPIs. Other tasks as assigned by the supervisor, and tasks based on a specific appointment
Essential Requirements
What you'll bring to the role:
Qualification: University degree (BSc) in pharmacy, medicine or other related natural science
Languages: Fluent in English;
Knowledge of Microsoft Office
Work Experience: 3 years of experience in clinical development or associated fields
Language
