Senior DMPK Project Lead

2 weeks ago

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

We are seeking a highly experienced and skilled Senior DMPK Project Lead to join our team at Lifelancer. As a key member of our organization, you will be responsible for leading projects related to early discovery, candidate selection, and clinical phases of drug development.

Key Responsibilities
  • Project Leadership: Oversee projects from early discovery to clinical phases, ensuring timely and successful completion.
  • Nonclinical DMPK Expertise: Provide expert guidance on nonclinical DMPK, including in vitro and in vivo activities, preclinical PK, translational PK, and PKPD biotransformation and bioanalysis.
  • Study Design and Data Interpretation: Design experimental studies and collaborate with other areas of the RD organization to deliver data and interpretations to support project goals.
  • Pharmacokinetics and Pharmacodynamics: Apply knowledge of preclinical pharmacokinetics and related disciplines to inform project decisions.
  • Collaboration and Communication: Work closely with project and Development Sciences colleagues to resolve or mitigate project-related ADME challenges.
  • Regulatory Compliance: 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 and Development: Provide scientific mentorship to support junior staff in their personal and professional 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: Demonstrate a thorough understanding of discovery and development DMPK, including modeling and simulation, and the ability to delineate the impact of chemical structure on measured properties.
  • Regulatory Knowledge: Possess a 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.
  • Track Record and Skills: Showcase a recognized track record of experience in DMPK/ADME, excellent knowledge in ADME/Enzymology/Drug Transporters, and the ability to couple data to optimization/selection of NCE both in discovery and development.
  • Leadership and Expertise: Demonstrate a proven track record of leading, understanding, and hands-on experience of drug metabolism and pharmacokinetics, including human PK prediction, DDI prediction, and mechanistic understanding to support late-stage programs.
  • PBPK Modeling and Translation: Possess an understanding of PKPD and preferably an understanding of PBPK modeling.
  • Mechanistic Understanding: Proven skills for in-depth mechanistic understanding of DMPK-related issues and the impact and value of translation to humans.
  • Industry Knowledge: Knowledge of the drug development processes in the Pharma Industry environment.

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