As a leader in the Pharmaceutical Industry in Belgium we advance a portfolio of Nanobody-based therapeutic programs in several major disease areas, including inflammation, haematology, immuno-oncology and oncology.
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.