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 PK/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
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