Principal Scientist, PKPD Modelling

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

Contact email: c.becker@panda-int.com
Job ref: 11149
Published: about 1 month ago

Job Description:

Support PKDM as a pharmacokinetics/pharmacometrician:

  • Represent PKDM and formulate strategies for specific projects
  • Conduct PK, population PK and PK/PD analysis
  • Formulate modeling 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
Responsibilities:
  • 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 auditable manner consistent with general accepted practices
  • Acts as expert in PK/PD matters and modeling concepts and their application to dose selection, study design, risk/benefit, and informing drug development decisions in close collaboration with project teams
  • Present at external scientific meetings as appropriate
  • Summarize documents for submission to regulatory agencies, including but not limited to the FDA, EMEA and HPB

Qualifications:

  • 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 modeling, PBPK modeling, population PK or PK/PD modeling

INTERESTED?

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