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    {"title": "DMPK Project Lead", "description": "Job SummaryWe are seeking a highly skilled DMPK Project Lead to join our team at Lifelancer. As a key member of our research organization, you will be responsible for leading projects from early discovery to clinical phases, ensuring the successful development of new compounds.Key ResponsibilitiesDesign and...

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 early discovery, candidate selection, and clinical phases of drug development.

Key Responsibilities
  • Project Leadership: Design and execute experimental studies, collaborate with cross-functional teams, and deliver data and interpretations to support project goals.
  • Expertise in DMPK: 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.
  • Project Support: Work with project and development sciences colleagues to resolve or mitigate project-related ADME challenges.
  • Innovation and Collaboration: Champion new approaches to project support and ensure Lifelancer stays at the forefront of DMPK science.
  • Document Preparation: Prepare DMPK sections of internal and regulatory documents, such as IND, IMPD, IB, and NDA.
  • Research and Publication: Participate in research aligned to DMPK and Lifelancer's portfolio, publish 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: 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.
  • ADME and Enzymology: 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.
  • Drug Metabolism and Pharmacokinetics: 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: Understanding of PKPD and preferably an understanding of PBPK modeling.
  • Translation and Impact: Proven skills for in-depth mechanistic understanding of DMPK-related issues and of the impact and value of translation to humans.
  • Industry Knowledge: Knowledge of the drug development processes in the Pharma Industry environment.