Job title:
DMPK Project Lead
Company
Job description
The individual will have project responsibility for early discovery towards candidate selection and into the clinical phases of the development. They will be responsible for the project aspects of nonclinical DMPK including in vitro and in vivo activities, pre-clinical PK, translational PK and PK-PD, biotransformation and bioanalysis contributions to projects to fulfil internal and regulatory requirements up to and including registration.What you’ll do
- Design appropriate experimental studies and liaise with other areas of the RD organization to deliver data and interpretations to support the project towards candidate selection and beyond
- Have expert understanding of the different approaches related to preclinical pharmacokinetics, as well as a good understanding of related disciplines (e.g., toxicokinetics, nonclinical safety, PKPD, PK modelling, drug design, clinical DMPK, bioanalytics and biomarkers)
- Apply their understanding of physical properties, DMPK and enzymology to input into the design of new compounds
- Work with the project and Development Sciences colleagues to resolve or risk-mitigate project-related ADME challenges
- Work with other areas in the DMPK organization to champion new, innovative approaches to project support and ensure UCB stays at the forefront of DMPK science
- Prepare the DMPK sections of internal and regulatory documents (e.g. IND, IMPD, IB, NDA)
- Participate in research aligned to DMPK and UCB’s portfolio to publish research papers in internationally recognized journals
- Provide scientific mentorship to support junior staff in their personal development
Interested? For this role we’re looking for the following education, experience, and skills
- PhD (or equivalent) in Pharmaceutics, Pharmacology, Drug metabolism or Pharmacokinetics, with 7 years of Post-Doctoral Industrial experience; or a related degree with 10 years industrial experience in DMPK science.
- A comprehensive understanding of discovery and development DMPK including modelling and simulation and a proven ability to delineate the impact of chemical structure on measured properties
- Wide experience in pharmaceutical RD including a knowledge of the regulatory requirements and experience working with regulatory agencies to fulfil the DMPK contribution to new drug submissions
- A recognized track record of experience in DMPK/ADME and excellent knowledge in ADME/Enzymology/Drug Transporters and knowledge of how to couple data to optimization/selection of NCE, both in discovery and development
- A proven track record of leading, understanding and hands-on experience of drug metabolism and pharmacokinetics, both in vitro and in vivo studies, human PK prediction, DDI prediction and mechanistic understanding to support late-stage programs
- Understanding of PKPD and preferably an understanding of PBPK modeling
- Proven skills for in depth mechanistic understanding of DMPK related issues and of the impact and value of translation to humans
- Knowledge of the drug development processes in the Pharma Industry environment.
Expected salary
Location
Slough, Berkshire
Job date
Sat, 31 Aug 2024 07:11:41 GMT
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