DMPK Project Lead

2 months ago

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

We are seeking a highly experienced and skilled DMPK Project Lead to join our team at Lifelancer. As a key member of our research and development team, you will be responsible for leading projects related to drug metabolism and pharmacokinetics (DMPK) and absorption, distribution, metabolism, and excretion (ADME).

Key Responsibilities
  • Project Leadership: Lead projects from early discovery to clinical phases, ensuring timely and successful delivery of DMPK and ADME-related data and interpretations.
  • Experimental Design: Design and execute experimental studies to support project goals, collaborating with other areas of the RD organization to deliver high-quality data.
  • Expertise and Knowledge: Possess a deep understanding of preclinical pharmacokinetics, toxicokinetics, nonclinical safety, PKPD, PK modeling, drug design, clinical DMPK, bioanalytics, and biomarkers.
  • Compound Design: Apply knowledge of physical properties, DMPK, and enzymology to inform the design of new compounds.
  • Collaboration and Innovation: Work with project and Development Sciences colleagues to resolve or mitigate project-related ADME challenges, and champion new innovative approaches to project support.
  • Document Preparation: Prepare DMPK sections of internal and regulatory documents, such as IND, IMPD, and IBND.
  • Research and Publication: Participate in research aligned to DMPK and UCB's portfolio, publishing research papers in internationally recognized journals.
  • Mentorship: Provide scientific mentorship to support junior staff in their personal development.
Requirements
  • Education and Experience: PhD (or equivalent) in Pharmaceutics, Pharmacology, Drug Metabolism, or Pharmacokinetics, with 7 years of postdoctoral industrial experience, or a related degree with 10 years of industrial experience in DMPK science.
  • Comprehensive Understanding: Possess a comprehensive understanding of discovery and development DMPK, including modeling and simulation, and a proven ability to delineate the impact of chemical structure on measured properties.
  • Regulatory Experience: Have wide experience in pharmaceutical RD, including knowledge of regulatory requirements and experience working with regulatory agencies to fulfill DMPK contributions to new drug submissions.
  • Track Record: Demonstrate 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.
  • Leadership and Expertise: Possess 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.
  • PBPK Modeling: Have an understanding of PKPD and preferably an understanding of PBPK modeling.
  • Mechanistic Understanding: Demonstrate proven skills for in-depth mechanistic understanding of DMPK-related issues and of the impact and value of translation to humans.
  • Industry Knowledge: Possess knowledge of the drug development processes in the Pharma Industry environment.

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