RBW Consulting
DMPK Project Lead
London
Posted about 14 hours ago
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RBW are working in partnership with a global organisation that are searching for an experienced DMPK Lead to implement strategy across all DMPK disciplines including PK/PD, ADME, Biotransformation etc. from early discovery through to clinical development.
Responsibilities:
- Lead the nonclinical DMPK strategy and design the appropriate studies to fulfil regulatory requirements
- Have an expert understanding of the different approaches related to nonclinical pharmacokinetics
- Apply understanding of physical properties, DMPK and enzymology to contribute to the design of new compounds
- Work with colleagues globally to resolve project-related ADME challenges
- Author high quality regulatory documents including INDs, CTAs and NDA filings
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- Educated to PhD in a scientific related discipline
- Minimum 5 years industry experience contributing to drug discovery projects with a track record of moving small molecules from target validation to first in humans
- Strong background in the area of DMPK/ADME across discovery and development
- Good understanding of PKPD and PBPK modelling
- Proven skills for in-depth mechanistic understanding of DMPK-related issues and of the impact and value of translation to humans
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Skills
DMPK Strategy
PK/PD
ADME
Biotransformation
Nonclinical Pharmacokinetics
Enzymology
Regulatory Document Authoring
IND Filings
CTA Filings
NDA Filings
PBPK Modelling
Drug Discovery
Small Molecules
Target Validation
Translational Science
Location