Strategic Associate Director, Clinical Pharmacology & MIDD

Biopharma Asia

Oxford

Hybrid

GBP 120,000 - 170,000

Full time

7 days ago
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Job summary

Moderna, based at Harwell, UK, is seeking an experienced Clinical Pharmacology expert to drive model‑informed drug development across oncology, immunology, and rare diseases. You will integrate nonclinical and clinical data, influence dose selection, and work with pharmacometrics and QSP colleagues in a highly matrixed team.

You will contribute to regulatory documents, INDs, and development strategies, leveraging software like R, NONMEM, and Monolix to advance the mRNA platform and therapies.

Qualifications

  • PhD in Clinical Pharmacology, Pharmacometrics, Pharmaceutics, Statistics, Engineering, or a related field with a minimum of 5 years of industry experience in clinical pharmacology/DMPK/Pharmacometrics
  • Solid understanding and practical application of quantitative pharmacology approaches, including PK/PD modeling, exposure‑response analysis, modeling and simulation, and translational PK/PD
  • Experience integrating nonclinical and clinical evidence to support first‑in‑human predictions, dose selection, dose optimization, and regulatory decision‑making.

Responsibilities

  • Develop fit‑for‑purpose Clinical Pharmacology development plans defining the quantitative strategy for programs, including dose selection and optimization, PK/PD characterization, immunogenicity assessment, pediatric development, across the development lifecycle
  • Independently perform and/or evaluate quantitative analyses, including PK/PD analyses, exposure‑response analyses, and model‑based approaches, translating findings into recommendations
  • Represent CQP on program teams and partner with Pharmacometrics and QSP colleagues to develop integrated analysis strategies and inform decisions across oncology, immunology, and rare diseases programs
  • Apply quantitative and mechanistic understanding to address complex development questions and support dose and regimen optimization, with relevance to mRNA therapeutics

Skills

Clinical pharmacology
Pharmacometrics
PK/PD modeling
Model-informed drug development
R
Phoenix WinNonlin
NONMEM
Monolix

Education

PhD in Clinical Pharmacology/Pharmacometrics/Pharmaceutics/Statistics/Engineering or related field

Tools

R
Phoenix WinNonlin
NONMEM
Monolix

Job description

Moderna, based at Harwell, UK, is seeking an experienced Clinical Pharmacology expert to drive model‑informed drug development across oncology, immunology, and rare diseases. You will integrate nonclinical and clinical data, influence dose selection, and work with pharmacometrics and QSP colleagues in a highly matrixed team.

You will contribute to regulatory documents, INDs, and development strategies, leveraging software like R, NONMEM, and Monolix to advance the mRNA platform and therapies.

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