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CK Group are recruiting for a Principal Scientist PKPD to join a global pharmaceutical company on a contract basis initially for 12 months. Our client is a is a global biopharmaceutical company focused on creating value for people living with severe diseases in immunology and neurology now and into the future.
Job Responsibility:
Participate in the development of non-clinical PKPD and GLP toxicokinetics studies
Lead the non-clinical PKPD strategy
Participate in protocol designs and writing by providing scientific support and input into regulatory study designs and protocols
Work collaboratively with the project teams representatives (e.g. Non-Clinical Safety, Bioanalysis, Clinical Pharmacology) and with the CROs, to ensure high quality data is generated
Deliver PKPD study reports and integrated summaries of the studies and participate in regulatory submission documents
Facilitate the advancement of drug candidates by building a thorough knowledge of the drug pharmacology and PKPD
Requirements:
Experience working in a matrix environment, to help design and set non-clinical PKPD study protocols, and analyze, interpret, and report PKPD results including GLP toxicokinetics studies
DMPK, etc.) with more than 5 years hands on experience in PKPD data analysis within a pharma company or CRO environment
Good understanding of pharmacology and pharmacologic processes related to disease and drug mechanisms
Hands-on experience in delivering high quality pre-clinical PKPD data analysis
Proficiency in the use of Phoenix- WinNonlin for PKPD analysis is essential
Good written and verbal communication skills, and ability to communicate study results and produce high standard reports that meet regulatory submission standards
It is essential that applicants hold entitlement to work in the UK
Nice to have:
Use of other modelling and simulation packages and tools, such as Berkeley Madonna and/or R would be advantageous
Record of publications and other external scientific contributions relevant to PKPD will be a plus