HRS are currently looking for a Pre-Clinical Study Manager / Associate Director to join a leading Biotherapeutics company based in the London area. As the Pre-Clinical Study Manager / Associate Director you will be responsible for overseeing the non-clinical PK and Toxicology studies and prepare regulatory documentation.
This is an ideal position for an experienced study manager in the biologics fields who is looking for an independent role.
The role offers flexibility working from home.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Pre-Clinical Study Manager / 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 writing the non-clinical PK module of regulatory documents, including but not limited to IND/BLA/MAA
3. You will use Phoenix WinNonLin for PK/PD modelling (training and support will be provided)
4. You will be responsible for determination of PK parameters and write PK reports. You will closely collaborate with the internal bioanalytical team.
To be successful in your application to this exciting opportunity as the Pre-Clinical Study Manager / Associate Director we are looking to identify the following on your profile and past history:
1. Relevant degree in Toxicology, Pharmacokinetics, Pharmacology and more.
2. Proven industry experience in overseeing non GLP & GLP studies focused on biologics.
3. Experience with analysing PK Studies from various species (nonhuman primates, rats etc)
Key Words: PK Study Manager / DMPK / Pharmakokinetics / PK / PD / PK Data / NonClinical Pharmacokinetics / Associate Director / Leader / Small Molecules / Large Molecules / London