Senior PKPD Modeller

JR United Kingdom; Hemel Hempstead; On-site; GBP 60,000 - 90,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Senior PK/PD Modeller to enhance drug development through innovative modeling strategies. This role demands expertise in pharmacokinetic and pharmacodynamic modeling, where you will collaborate with cross-functional teams to influence key decisions. If you possess a strong analytical background and advanced modeling skills, you will thrive in this collaborative environment, contributing to transformative therapies while enjoying competitive compensation and flexibility.

Benefits

Comprehensive benefits

Flexible work arrangements

Professional growth opportunities

Qualifications

• 5-8 years experience in PK/PD modeling, preferably in pharmaceuticals.
• Proficiency in relevant software tools and strong organizational skills.
• Demonstrated ability to interpret complex data for diverse stakeholders.

Responsibilities

• Lead PK/PD modeling for preclinical and clinical programs.
• Translate quantitative data for dose selection and trial design.
• Author clinical study protocols and contribute to regulatory submissions.

Skills

Analytical skills

Project management

Communication

Education

PhD in Pharmaceutical Sciences, Pharmacology, Applied Mathematics, Biomedical Engineering or related field

PharmD/MSc with significant modeling experience

Tools

NONMEM

Monolix

R

Phoenix WinNonlin

MATLAB

Job description

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We are seeking an experienced and driven Senior PK/PD Modeller to 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.