DMPK Project Lead

2 weeks ago

Slough, Slough, United Kingdom Lifelancer Full time
About the Role

The successful candidate will be responsible for leading projects in early discovery and development, focusing on candidate selection and clinical phases. This role will oversee nonclinical DMPK activities, including in vitro and in vivo studies, pre-clinical PK, translational PK and PK-PD, biotransformation, and bioanalysis. The individual will contribute to projects to meet internal and regulatory requirements up to and including registration.

Key Responsibilities
  • Design and execute experimental studies, collaborating with other areas of the Research and Development organization to deliver data and interpretations to support project progress.
  • Develop and maintain a deep understanding of preclinical pharmacokinetics, as well as related disciplines such as toxicokinetics, nonclinical safety, PKPD, PK modeling, drug design, clinical DMPK, bioanalytics, and biomarkers.
  • Apply knowledge of physical properties, DMPK, and enzymology to inform the design of new compounds.
  • Work with project and Development Sciences colleagues to resolve or mitigate project-related ADME challenges.
  • Collaborate with other areas in the DMPK organization to champion new, innovative approaches to project support and ensure the company remains at the forefront of DMPK science.
  • Prepare DMPK sections of internal and regulatory documents, such as IND, IMPD, IB, and NDA.
  • Participate in research aligned to DMPK and the company's portfolio, with the goal of publishing research papers in internationally recognized journals.
  • Provide scientific mentorship to support the development of junior staff.
Requirements
  • 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 of industrial experience in DMPK science.
  • A comprehensive understanding of discovery and development DMPK, including modeling and simulation, and the ability to delineate the impact of chemical structure on measured properties.
  • Wide experience in pharmaceutical R&D, including knowledge of regulatory requirements and experience working with regulatory agencies to fulfill DMPK contributions to new drug submissions.
  • A recognized track record of experience in DMPK/ADME and excellent knowledge in ADME/Enzymology/Drug Transporters, as well as the ability to couple data to optimization/selection of NCEs, 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 the impact and value of translation to humans.
  • Knowledge of the drug development processes in the Pharma Industry environment.

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