Principal Pk Scientist

2 weeks ago

London, United Kingdom Hyper Recruitment Solutions Ltd Full time

HRS are currently looking for a Principal PK Scientist/Associate Director to join a leading Biotherapeutics company based in the London area. As the Principal PK Scientist/Associate Director you will be responsible for overseeing the non-clinical PK andToxicology studies and prepare regulatory documentation. You will be also use conduct PK/PD Modelling using WinNonLin.
**KEY DUTIES AND RESPONSIBILITIES**:
Your duties as the Principal PK Scientist/Associate Director will be varied however the key duties and responsibilities are as follows:
1. You will design the PK phase of non-GLP and GLP studies and act as the main point of contact for CRO-based outsourced work.
2. You will be responsible for determination of PK parameters and write PK reports. You will closely collaborate with the internal bioanalytical team.
3. You will use Phoenix WinNonLin for PK/PD modelling.
4. You will be responsible for writing the non-clinical PK module of regulatory documents, including but not limited to IND/BLA/MAA
**ROLE REQUIREMENTS**:
1. Relevant degree in Toxicology, Pharmacokinetics, Pharmacology and more.
2. Proven industry experience in overseeing ADME studies, non GLP & GLP studies and or Toxicology studies.
3. A working knowledge using software for modelling of nonclinical PK data. Experience with Phoenix WinNonLin is ideal.
Key Words: PK Study Manager / Pharmakokinetics / PK / PD / Modelling / PK Data / NonClinical Pharmacokinetics / Associate Director / Principal Scientist / Biotech / Small Molecules / Large Molecules / London

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