Senior PKPD Modeller

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

Job summary

A leading company in the pharmaceutical sector seeks an experienced Senior PK/PD Modeller to join their Clinical Pharmacology team. The role involves designing and implementing PK/PD modeling strategies to support drug development, collaborating with various stakeholders, and contributing to regulatory submissions. Candidates should have a PhD or equivalent experience in relevant fields, alongside a strong background in modeling and simulation.

Benefits

Competitive salary

Comprehensive benefits

Flexible work arrangements

Professional growth opportunities

Qualifications

• Minimum of 5–8 years of hands-on experience in PK/PD modeling.
• Strong understanding of regulatory guidance related to modeling.
• Track record of contributions to regulatory filings and publications.

Responsibilities

• Lead development and execution of PK/PD modeling strategies.
• Author clinical study protocols and regulatory submissions.
• Mentor junior scientists in PK/PD methodologies.

Skills

Data interpretation

Quantitative analysis

Collaboration

Project management

Education

PhD in Pharmaceutical Sciences or related field

PharmD or MSc with significant modeling experience

Tools

NONMEM

Monolix

R

Phoenix WinNonlin

MATLAB

Job description

Social network you want to login/join with:

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.