Senior PKPD Modeller

Barrington James
Northampton
8 months ago
Applications closed

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Job Summary:

We are seeking an experienced and drivenSenior PK/PD Modellerto join our Clinical Pharmacology team. In this role, you will be responsible for the design, development, and implementation of pharmacokinetic/pharmacodynamic (PK/PD) modeling strategies to support drug development across all phases. You will collaborate cross-functionally with pharmacometrics, clinical, regulatory, and nonclinical teams to provide quantitative insight into drug behavior and inform key decision-making.


Key Responsibilities:

  • Lead the development and execution of PK/PD modeling and simulation strategies for preclinical and clinical programs.
  • Perform population pharmacokinetics (PopPK), exposure-response (E-R), and physiologically-based pharmacokinetic (PBPK) modeling.
  • Translate complex quantitative data into actionable insights for dose selection, trial design, and regulatory interactions.
  • Author or contribute to clinical study protocols, pharmacometric analysis plans, and regulatory submissions (IND, NDA, BLA, MAA, etc.).
  • Serve as subject matter expert in modeling approaches and mentor junior scientists in PK/PD methodologies.
  • Collaborate with biostatistics, clinical pharmacology, regulatory affairs, and other key stakeholders to integrate modeling insights into overall development strategy.
  • Maintain awareness of new scientific and regulatory developments in pharmacometrics and contribute to external publications and presentations when appropriate.


Qualifications:

  • PhD in Pharmaceutical Sciences, Pharmacology, Applied Mathematics, Biomedical Engineering, or related field; or PharmD/MSc with significant modeling experience.
  • Minimum of 5–8 years of hands-on experience in PK/PD modeling, preferably within the pharmaceutical or biotechnology industry.
  • Proficiency in NONMEM, Monolix, R, Phoenix WinNonlin, MATLAB, or other relevant software tools.
  • Strong understanding of regulatory guidance and expectations related to modeling and simulation (e.g., FDA, EMA).
  • Demonstrated ability to interpret and communicate complex data effectively to both technical and non-technical stakeholders.
  • Track record of contributions to regulatory filings and/or scientific publications.
  • Strong analytical, organizational, and project management skills.


Preferred Skills:

  • Experience in mechanistic modeling or QSP (Quantitative Systems Pharmacology).
  • Familiarity with PBPK modeling platforms (e.g., Simcyp, GastroPlus).
  • Experience in oncology, CNS, immunology, or other specific therapeutic areas is a plus.
  • Leadership in cross-functional project teams.


Why Join Us?

You’ll be part of a collaborative and innovative environment where your expertise will directly impact the development of transformative therapies. We offer a competitive salary, comprehensive benefits, flexible work arrangements, and the opportunity to grow professionally in a science-driven organization.

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