Senior Principal Scientist, Development

Location Diegem, Belgium
Discipline: Chemicals, Biotechnology
Job type: Permanent
Contact name: Cherish Becker

Contact email: c.becker@panda-int.com
Job ref: 10490
Published: 4 months ago



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.

 

YOUR RESPONSIBILITIES

  • 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

 

YOUR PROFILE

  • 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.

INTERESTED?

For more information please contact me at:  +31 (0)20 20 44 502 or c.becker@panda-int.com.