Senior PKPD Modeller

JR United Kingdom; Watford; 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 their Clinical Pharmacology team. This pivotal role involves designing and implementing modeling strategies for drug development, collaborating with various departments to support regulatory processes and clinical insights. The candidate will require extensive experience in PK/PD modeling and a high level of analytical skills, contributing to innovative therapeutic advancements.

Benefits

Competitive salary

Comprehensive benefits

Flexible work arrangements

Opportunity for professional growth

Qualifications

• 5-8 years of hands-on experience in PK/PD modeling.
• Strong understanding of regulatory guidance related to modeling.
• Experience in contributions to regulatory filings or scientific publications.

Responsibilities

• Lead the development and execution of PK/PD modeling strategies.
• Translate complex quantitative data into actionable insights.
• Mentor junior scientists in PK/PD methodologies.

Skills

Analytical skills

Project management

Communication

Collaboration

Education

PhD in Pharmaceutical Sciences or related field

MSc with significant modeling experience

Tools

NONMEM

R

MATLAB

Phoenix WinNonlin

Monolix

Job description

Social network you want to login/join with:

Senior PKPD Modeller, watford, hertfordshire

col-narrow-left

Client:

Barrington James

Location:

watford, hertfordshire, United Kingdom

Job Category:

Other

-

EU work permit required:

Yes

col-narrow-right

Job Views:

3

Posted:

31.05.2025

Expiry Date:

15.07.2025

col-wide

Job Description:

Job Summary:

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.