Principal PBPK Consultant.

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Principal PBPK Consultant based in the United States.

As a Principal PBPK Consultant, you will play a key role in advancing drug discovery and development through innovative physiologically-based pharmacokinetic (PBPK) and physiologically-based biopharmaceutics modeling (PBBM).
You will lead and contribute to complex scientific consulting projects, helping pharmaceutical clients make informed decisions throughout the drug development lifecycle.
Working with multidisciplinary teams and international clients, you will translate scientific data into robust modeling strategies and actionable insights.
Your expertise will support critical applications, including first-in-human dose prediction, drug-drug interaction assessments, food effect evaluations, and special population analyses.
You will also contribute to regulatory interactions, scientific publications, and the continuous advancement of PBPK/PBBM methodologies.
This position offers an opportunity to combine scientific leadership, client engagement, and business development within a globally recognized scientific consulting environment.

Accountabilities

In this role, you will lead and support scientific consulting engagements, applying advanced PBPK/PBBM methodologies to address complex pharmaceutical research and development challenges. Your responsibilities will include:

• Plan, develop, and apply PBPK/PBBM models to address key drug development questions, including first-in-human dose predictions, drug-drug interaction risks, food effects, special populations, and biopharmaceutics.

• Lead and contribute to all stages of client projects, from initial data reviews and modeling strategy development to final scientific reporting.

• Prepare modeling analysis plans, technical documentation, and comprehensive PBPK/PBBM modeling reports in accordance with relevant regulatory guidance.

• Support regulatory interactions and scientific reviews related to client projects.

• Serve as a subject matter expert in business development activities and help identify and secure new consulting opportunities, depending on experience.

• Maintain strong relationships with existing and prospective clients through regular scientific discussions and technical presentations.

• Conduct scientific quality control and peer reviews of modeling work performed by other PBPK scientists.

• Stay up to date with emerging scientific developments, regulatory expectations, and innovations in PBPK/PBBM modeling.

• Contribute to internal scientific initiatives, consulting activities, and broader business development projects.

• Strengthen scientific visibility through publications, conference presentations, and active participation in discussions with clients and the wider scientific community.

Requirements

The ideal candidate combines extensive PBPK/PBBM modeling expertise with strong scientific judgment, communication skills, and the ability to translate complex technical challenges into practical solutions. The following qualifications are expected:

• PhD in a relevant scientific discipline or equivalent professional experience in IVIVE, drug metabolism, pharmacokinetics, or a related field.

• At least 7 years of professional experience in PBPK/PBBM modeling.

• Extensive knowledge and practical experience applying PBPK modeling throughout the drug discovery and development lifecycle.

• Strong understanding of IVIVE, drug metabolism, and pharmacokinetics.

• Familiarity with the regulatory acceptance and application of PBPK/PBBM approaches across relevant regulatory authorities.

• Demonstrated experience with leading PBPK/PBBM modeling platforms, ideally including Simcyp.

• Excellent written and verbal communication skills, with the ability to engage effectively with clients, scientific peers, academic institutions, and regulatory agencies.

• Strong analytical thinking, scientific problem-solving abilities, and attention to detail.

Additional qualifications that would be an advantage:

• Previous experience in scientific consulting or client-facing pharmaceutical projects.

• Data analytics and programming experience, particularly using R.

• Experience applying artificial intelligence tools and methodologies to PBPK/PBBM modeling or consulting workflows.

Benefits

• Opportunity to work within an internationally recognized scientific and consulting environment.

• Exposure to a diverse portfolio of pharmaceutical and biopharmaceutical development projects.

• Collaboration with multidisciplinary experts and leading professionals in PBPK/PBBM modeling.

• Opportunities for continuous professional development and scientific knowledge sharing.

• Support for attending scientific meetings and conferences as part of ongoing professional education.

• Opportunities to publish research, present scientific findings, and contribute to the wider scientific community.

• A unique professional environment combining academic research and commercial consulting experience.

• Opportunities to develop expertise and contribute to scientific innovation across the drug development industry.