Senior Director, QSP/ PBPK Modeling

ClinLab Solutions Group; Lexington (MA); On-site; USD 180,000 - 250,000; Full time

Job summary

ClinLab Solutions Group seeks an experienced leader to oversee development and application of quantitative pharmacology models supporting drug discovery and development.

You will drive model-informed strategies, integrating non-clinical and clinical data to guide PK/PD, dose selection, and clinical strategy, with a focus on regulatory readiness and cross-functional collaboration.

Qualifications

• Ph.D. in Pharmacology, Pharmaceutics, Pharmaceutical Sciences, Biomedical Engineering or related quantitative discipline.
• 10+ years of quantitative pharmacology/pharmacometrics experience with progression to leadership.
• Hands-on expertise in nonlinear mixed-effects and PK/PD modeling; translate non-clinical data to human predictions.
• Experience contributing to regulatory interactions and modeling in early-stage development.

Responsibilities

• Lead design, development, validation, and application of pharmacology models for drug development programs.
• Integrate non-clinical and clinical PK/PD, efficacy and biomarker data to inform dose selection and trial design.
• Provide quantitative support for first-in-human, dose escalation, and proof-of-concept studies.
• Drive model-informed drug development strategies and influence portfolio decisions.
• Collaborate with clinical and translational teams to align modeling with regulatory expectations.
• Author and review modeling sections for regulatory documents and regulatory interactions as SME.
• Ensure rigor, documentation quality, and regulatory readiness of all modeling deliverables.
• Evaluate and implement new modeling methodologies and best practices.

Skills

Quantitative modelling

Nonlinear mixed-effects

PK/PD modeling

Regulatory communication

Cross-functional collaboration

Strategic leadership

Clear scientific communication

Education

Ph.D. in Pharmacology or related field

Tools

MATLAB/SimBiology

OSP Suite

Simcyp

GastroPlus

Monolix

R

Job description

Work Location: Middlesex County, Massachusetts

Summary:

Seeking a highly experienced leader to oversee the development and application of quantitative pharmacology models supporting drug discovery and development. This role will drive model-informed strategies, integrating non-clinical and clinical data to inform pharmacokinetics, pharmacodynamics, dose selection, and clinical strategy. The position requires strong scientific, strategic, and communication skills, with a focus on cross-functional collaboration and regulatory readiness.

Responsibilities:

• Lead the design, development, validation, and application of empirical and mechanistic pharmacology models for drug development programs.
• Integrate non-clinical and clinical PK/PD, efficacy, and biomarker data to inform human PK predictions, dose selection, and clinical trial design.
• Provide quantitative support for first-in-human, dose escalation, and proof-of-concept studies.
• Drive model-informed drug development strategies, influencing key development and portfolio decisions.
• Collaborate closely with clinical and translational teams to align modeling, bioanalytical strategies, and clinical endpoints.
• Author and review modeling sections for regulatory documents and support regulatory interactions as a subject matter expert.
• Ensure scientific rigor, documentation quality, and regulatory readiness of all modeling deliverables.
• Evaluate and implement new modeling methodologies, platforms, and best practices in line with industry and regulatory standards.

Qualifications:

• Ph.D. in Pharmacology, Pharmaceutics, Pharmaceutical Sciences, Biomedical Engineering, Applied Mathematics, or a related quantitative discipline.
• 10+ years of relevant experience in quantitative pharmacology, pharmacometrics, or systems pharmacology, with demonstrated progression to scientific leadership roles.
• Deep hands-on expertise in nonlinear mixed-effects modeling, mechanistic PK/PD modeling, and translation of non-clinical PK/PD to human dose prediction using standard modeling software (e.g., Matlab/SimBiology, OSP Suite, Simcyp, Gastroplus, Monolix, R).
• Strong understanding of drug development, clinical trial design, and regulatory expectations related to pharmacology and pharmacometrics.
• Experience contributing to regulatory interactions related to modeling and simulation, with proven application of modeling approaches to clinical decision making, especially in early-stage development.
• Ability to communicate complex quantitative concepts clearly to multidisciplinary, non-modeling audiences.
• Ability to work effectively in a highly collaborative environment, demonstrating a strong sense of urgency and agility.
• Excellent problem-solving skills and an adaptable growth mindset.

Published Category: Analytical & Process Development