Director Pharmacokinetics (PK) & Quantitate Systems Pharmacology (QSP)

CSL; Emea; On-site; IDR 1.670.564.000 - 2.338.791.000; Full time

Job summary

A leading biotech company in Indonesia is seeking a PK / QSP Lead to oversee the development of pharmacokinetic modeling strategies across therapeutic programs. The ideal candidate will have over 10 years in the pharmaceutical industry, with a Ph.D. in a relevant field. Responsibilities include leading a team of scientists, collaborating with cross-functional teams, and contributing to regulatory submissions. The role emphasizes innovation and scientific excellence.

Benefits

Well-being support

Professional development opportunities

Qualifications

• 10+ years of pharmaceutical industry experience.
• Proven track record of applying modeling to support drug development.
• Experience with omics data integration or AI-enhanced modeling is a plus.

Responsibilities

• Lead the development and execution of PK, PBPK, and QSP modeling strategies.
• Collaborate with research and clinical development teams.
• Contribute to regulatory documents and modeling reports.

Skills

Pharmacokinetics

Modeling software proficiency

Leadership

Communication skills

Project management

Education

Ph.D. in Pharmacokinetics or related field

Tools

Modeling software for PK / PD, PBPK, QSP

Job description

Description

Summary

The PK / QSP Lead is responsible for leading the design, execution, and interpretation of pharmacokinetic (PK), toxicokinetic (TK), physiologically-based pharmacokinetic (PBPK), and quantitative systems pharmacology (QSP) modeling strategies to support drug discovery, nonclinical and development programs across multiple therapeutic areas.

Main Responsibilities

Strategic Leadership & Scientific Expertise

Lead the development and execution of integrated PK, PBPK, and QSP modeling strategies across multiple therapeutic programs.

Serve as the subject matter expert (SME) in modeling and simulation, advising project teams on optimal study design, dose selection, and risk assessment.

Champion model-informed drug development (MIDD) approaches to enhance translational understanding and regulatory confidence.

PK and Model Development

Lead the design and execution of nonclinical PK and TK studies to support research and IND-enabling packages.

Lead the design and execution of PBPK and QSP modeling strategies across multiple programs.

Cross-Functional Collaboration

Act as Sr. PK / QSP lead on TA teams.

Collaborate closely with Research, Nonclinical development functions, Clinical Development and Clinical Pharmacometrics to ensure alignment of Pharmacokinetic and modeling strategies with program goals.

Participate in cross-functional project teams, providing scientific input and modeling insights to guide key development decisions.

Provide expert input into due diligence for in-licensing or partnership opportunities.

Regulatory & Documentation

Contribute to and review Nonclinical Pharmacokinetic sections for submission documents.

Prepare and review modeling reports and regulatory documents.

Innovation & Continuous Learning

Stay abreast of emerging trends, technologies, and regulatory expectations in PK, PBPK, and QSP modeling.

Contribute to scientific publications, conference presentations, and internal knowledge-sharing initiatives.

Team Leadership

Lead and mentor a team of Principal and Sr. scientists.

Foster a culture of scientific excellence, innovation, and continuous learning.

Qualifications and Experience Requirements

Ph.D. in Pharmacokinetics, Systems Pharmacology, Pharmacometrics, Biomedical Engineering or a related field.

10+ years of pharmaceutical industry experience in / PD, PBPK, and/or QSP modeling.

Proven track record of applying modeling to support drug development and regulatory submissions.

Proficiency in modeling software for PK / PD, PBPK, QSP.

Strong understanding of ADME, pharmacology, and translational science.

Excellent communication, leadership, and project management skills.

Experience with omics data integration, machine learning, or AI-enhanced modeling is a plus.

Ability to manage multiple projects and timelines.

Experience across multiple therapeutic areas and modalities is highly desirable.

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you.