As a leader in the Pharmaceutical Industry in Belgium we advance a portfolio of Nanobody-based therapeutic programs in several major disease areas, including .
- Support PKDM as a pharmacokinetics/pharmacometrician
- Represent PKDM and formulate strategies for specific projects
- Conduct PK, population PK and PK/PD analysis
- Formulate modelling and simulation (M&S) strategies for specific projects
- Develop and review protocols, analysis plans and study reports
- Prepare CIB/IMPD/IND and other regulatory documents, when needed
- Capacity to integrate biological/pharmacological processes into complex PK/PD analysis in early development programs, including mathematical models and hands-on M&S proficiency
- Anticipation of opportunities to support an efficient drug development
- Capacity to accurately record M&S activities in an audit-able manner consistent with general accepted practices
- Will train/mentor others
- Demonstrate a proficiency in scheduling multiple activities
- Monitor compliance with any appropriate company guidelines
- Independently accountable for meeting project timelines
- M.Sc. or PharmD or MD or PhD with at least 8-10 years of R&D experience in industry, with focus on clinical or translational research.
- Broad knowledge and understanding of pharmacological processes.
- Knowledge and mindset in translational research and bridging strategies.
- Knowledge of regulatory requirements and experience in interactions with regulatory authorities.
- Technical expertise in most of the following areas: clinical trial simulations technologies, PK modelling, PBPK modelling, population PK or PK/PD modelling
- Demonstrated ability to contribute to early development strategy, to resol.ve issues and to Ensure successful integration of pharmacokinetic aspects in drug development programs.
- Be able to operate in a multicultural environment and participate in international teams.
- Participate in designing the early clinical development and overall translational medicine plans, according to the strategy developed by the Company.
- Acts as expert in PK/PD matters and modelling concepts and their application to dose selection, study design, risk/benefit, and informing drug development decisions in close collaboration with project teams.
- Participate and/or present at departmental, external and international meetings within the company.
- Prepare abstracts, posters and manuscripts for presentation and/or publication.
- Present at external scientific meetings as appropriate.
- Summarise documents for submission to regulatory agencies, including but not limited to the FDA, EMEA and HPB.
- Can act as a resource to address technical and theoretical issues in M&S area.
- Able to lead development of new technologies.
- Possess excellent interpersonal communications skills commensurate with working in a multicultural organization.
For more information please contact me at: +31 (0)20 20 44 502 or email@example.com.