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How much do pbpk modeling jobs pay per hour?

As of Sep 8, 2026, the average hourly pay for pbpk modeling in the United States is $40.33, according to ZipRecruiter salary data. Most workers in this role earn between $31.25 and $43.51 per hour, depending on experience, location, and employer.

What is a pbpk modeling?

A PBPK (Physiologically Based Pharmacokinetic) Modeling job involves developing mathematical models to predict the absorption, distribution, metabolism, and excretion (ADME) of drugs in the human body. Professionals in this role use computational tools to integrate physiological, biochemical, and drug-specific data to support drug development, dose optimization, and regulatory submissions. PBPK modelers work in pharmaceutical companies, regulatory agencies, and research institutions to improve drug safety and efficacy predictions. Strong expertise in pharmacokinetics, coding (e.g., MATLAB, R, Python), and data analysis is essential for this role.

What are the typical responsibilities and daily activities of someone working in pbpk modeling?

Professionals in PBPK Modeling are responsible for designing and validating physiologically-based pharmacokinetic models to predict the absorption, distribution, metabolism, and excretion of drugs in various populations. Daily activities often include gathering and analyzing experimental data, coding or customizing models using specialized software, and preparing technical reports or presentations for stakeholders. Collaboration with clinical pharmacologists, toxicologists, and regulatory teams is common, as modelers help inform study design and regulatory strategy. The role involves both independent research and teamwork, providing valuable insight throughout the drug development process.

What are the key skills and qualifications needed to thrive in the pbpk modeling position, and why are they important?

To thrive in PBPK Modeling, you need a strong background in pharmacokinetics, mathematics, and systems pharmacology, typically supported by an advanced degree in pharmacy, pharmacology, or a related field. Expertise in specialized software such as Simcyp, GastroPlus, or MATLAB, along with familiarity with regulatory guidelines, is important. Strong analytical skills, attention to detail, and effective communication abilities help you interpret data and present modeling results to multidisciplinary teams. These abilities ensure accurate predictive models that support drug development and regulatory submissions.

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Pbpk Modeling jobs near you
Infographic showing various Pbpk Modeling job openings in the United States as of September 2026, with employment types broken down into 1% Internship, 87% Full Time, 10% Part Time, and 2% Contract. Highlights an 81% Physical, 4% Hybrid, and 15% Remote job distribution, with an average salary of $83,896 per year, or $40.3 per hour.

Vice President, Quantitative Sciences & Development

Sk Life Science, Inc.

Paramus, NJ • On-site

Full-time

Medical, Dental, Vision, Life, Retirement

Re-posted 18 days ago

Job description

Overview
The Vice President, Quantitative Sciences & Development provides strategic, scientific, and operational leadership for the company's Clinical Pharmacology, Pharmacometrics, Toxicology, DMPK, Biostatistics, Statistical Programming, and Clinical Data Management functions across all phases of drug development.
This executive is responsible for developing and overseeing execution of integrated quantitative strategies that support efficient translation from non-clinical development, clinical development, regulatory submissions, and evidence generation while ensuring delivery of high-quality, inspection-ready clinical data and statistical analyses. The VP serves as a key member of the Clinical Leadership Team and partners closely with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Pharmacovigilance, Quality Assurance, and external CROs to advance the company's portfolio.
Responsibilities
Develop and implement the company's Clinical Pharmacology, Biometrics and Data Sciences strategy aligned with corporate development objectives.
Serve as a key member of the Clinical Leadership Team.
Build organizational capabilities to support a growing clinical pipeline.
Lead organizational planning, budgeting, resource allocation, and vendor strategy.
Represent Clinical Pharmacology, Data Management, and Biometrics in governance committees and executive reviews.
Clinical Pharmacology & Toxicology
Provide strategic oversight for:
  • First-in-human (FIH) study design
  • SAD/MAD studies
  • Food-effect and drug-drug interaction (DDI) studies
  • QT/QTc and organ impairment studies
  • Population PK, PBPK modeling, exposure-response analyses, dose optimization, and model-informed drug development (MIDD)
  • Nonclinical toxicology strategy, including general, reproductive, developmental, genotoxicity, and carcinogenicity studies, as applicable
  • Guide clinical pharmacology and toxicology strategy across all phases of development.
  • Review and approve PK/PD and toxicology protocols, analysis plans, study reports, and regulatory submissions.
  • Interpret nonclinical safety data to support first-in-human studies, dose selection, and benefit-risk assessments.
  • Ensure compliance with FDA, EMA, PMDA, and ICH guidance and represent the function in regulatory interactions and cross-functional governance.

Biostatistics
Provide strategic oversight for all biostatistical activities supporting clinical development.
Responsibilities include:
  • Develop statistical strategy across the clinical development portfolio.
  • Oversee study design and statistical methodology.
  • Review and approve:
    • Statistical Analysis Plans (SAPs)
    • Protocol statistical sections
    • Interim analyses
    • Adaptive design methodologies
    • Integrated summaries
    • TLFs (Tables, Listings, and Figures)
  • Guide sample size estimation, endpoint selection, multiplicity strategies, estimands, and innovative trial designs.
  • Support Data Monitoring Committees (DMCs), Independent Review Committees (IRCs), and interim decision-making.
  • Provide statistical leadership for:
    • NDA/BLA submissions
    • FDA Type B/C meetings
    • EMA Scientific Advice
    • PMDA interactions
  • Ensure statistical integrity and regulatory compliance across all studies.

Statistical Programming
Provide executive oversight of statistical programming activities including:
  • SDTM and ADaM dataset development
  • TLF (Tables, Listings, and Figures) generation
  • CDISC implementation
  • SAS and R programming standards
  • Submission-ready datasets
  • Define.xml preparation
  • Regulatory submission programming
  • Automation and programming innovation
  • Validation and quality control processes

Establish efficient programming standards that ensure timely database analyses and global submission readiness.
Clinical Data Management
  • Provide executive oversight of all Clinical Data Management activities.
  • Ensure high-quality, inspection-ready clinical databases.
  • Oversee:
    • IWRS (Interactive Web Response System)/IRT (Interactive Response Technology) design
    • Database design
    • CRF/eCRF development
    • Data review plans
    • Data cleaning
    • Medical coding
    • Database lock
    • Data quality metrics
  • Establish enterprise data standards including:
    • CDISC SDTM
    • CDASH
    • Controlled Terminology
  • Ensure timely delivery of clean data for interim analyses and regulatory submissions.
  • Lead implementation of innovative technologies including:
    • Risk-based data review
    • Centralized monitoring
    • AI-assisted data review
    • Electronic Clinical Outcome Assessments (eCOA)
    • Wearable device integration
    • Decentralized clinical trial data capture

Cross-Functional Collaboration
Partner closely with:
  • Clinical Development
  • Clinical Operations
  • Regulatory Affairs
  • Medical Affairs
  • Safety/Pharmacovigilance
  • Medical Writing
  • Clinical Supply
  • Quality Assurance
  • Commercial
  • Health Economics & Outcomes Research (HEOR)

Regulatory Leadership
  • Provide clinical pharmacology leadership for regulatory interactions.
  • Lead preparation of:
    • Clinical Pharmacology Summary
    • Module 2.7 documents
    • Module 5 components
    • NDA/BLA/MAA submissions
  • Support FDA Type A/B/C meetings, End-of-Phase meetings, and Advisory Committees.
  • Respond to global regulatory information requests.

Vendor Management
  • Select, oversee, and evaluate CROs and specialty vendors.
  • Establish KPIs and performance metrics.
  • Manage budgets and contracts.
  • Ensure vendor compliance with GCP and company quality standards.

Quality & Compliance
  • Ensure compliance with:
    • ICH GCP
    • FDA regulations
    • EMA guidance
    • 21 CFR Part 11
    • GCDMP
    • Company SOPs
  • Maintain inspection readiness.
  • Support regulatory inspections and audits.

People Leadership
  • Build, mentor, and lead high-performing Clinical Pharmacology, Biometrics and Data Management teams.
  • Recruit and retain top scientific and operational talent.
  • Foster a culture of innovation, collaboration, accountability, and continuous improvement.
  • Develop succession plans and leadership capabilities.

Qualifications
PhD, PharmD, MD, or equivalent advanced degree in:
  • Clinical Pharmacology
  • Pharmaceutical Sciences
  • Pharmacokinetics
  • Biomedical Sciences
  • Biostatistics
  • Medicine
  • Related scientific discipline

Work Experience:
  • 15+ years of progressive pharmaceutical or biotechnology industry experience.
  • Significant experience in both Clinical Pharmacology and Clinical Data Management/Biometrics leadership.
  • Experience leading programs from early clinical development through regulatory approval.
  • Demonstrated success supporting NDA/BLA submissions.
  • Executive leadership experience preferred.
  • Experience managing global CROs and strategic partnerships.
  • Experience in neuroscience, CNS, rare disease, oncology, or specialty pharmaceuticals.
  • Experience supporting global development programs.
  • Familiarity with AI-enabled clinical development platforms and advanced analytics.
  • Experience implementing modern data strategies, including real-world data integration and decentralized clinical trial technologies.

Compensation & Benefits
The anticipated salary range for this position is $325,000 to $375,000. Actual compensation may vary based on factors including experience, qualifications, skills, and business needs.
In addition to base salary, SK Life Science offers a competitive benefits package, including a 401(k) plan with company match and medical, dental, and vision coverage. Benefits are subject to eligibility requirements and may be modified at the Company's discretion.

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