Advisor, PK/PD & Pharmacometrics

Jobtailor; Indianapolis (IN); On-site; USD 140,000 - 180,000; Full time

Job summary

Jobtailor is seeking a highly experienced Pharmacometrician to lead population PK/PK‑PD modeling efforts. The role involves independent model development, end‑to‑end analysis, and regulatory submissions, with strong collaboration across statistics, regulatory, medical, and clinical development teams.

The successful candidate will work with NONMEM/Monolix, R, and mrgsolve to deliver robust analyses, communicate complex results, and advance development strategies within a fast‑paced environment.

Qualifications

• PhD in pharmacometrics or related modelling area.
• Experience in population PK and/or PK/PD modeling.
• Experience with NONMEM or Monolix, R, and mrgsolve.
• Hands-on experience across the full modeling workflow, including data handling, exploratory data analysis, covariate evaluation and modeling, evaluation, simulation, and reporting.
• Experience contributing to a regulatory submission or health authority response.
• Reproducible analysis practice, including Git and literate reporting (Quarto).
• Active engagement with AI and automation in a pharmacometrics context.
• Ability to work with cross-functional colleagues.

Responsibilities

• Independently develop, evaluate, and apply population PK/PK‑PD models using NONMEM/Monolix with R for data handling, diagnostics, and simulation.
• Serve as PMx lead on assigned programs.
• Author analysis plans and modeling reports for regulatory submissions.
• Own analyses end to end and provide dose justification and exposure‑response analyses.
• Respond to health authority questions and support vendor analyses.
• Communicate quantitative results to project teams and senior partners.
• Build cross‑functional networks across statistics, regulatory, medical, and clinical development.

Skills

Population PK/PD modeling

Data handling

Exploratory data analysis

Model evaluation

Simulation

Dose justification

Exposure‑response analysis

Reproducible analysis

Cross-functional collaboration

Communication

Education

PhD in pharmacometrics or related modelling area

Tools

NONMEM

Monolix

R

Mrgsolve

Git

Quarto

Job description

• Independently develop, evaluate, and apply population PK and PK/PD models to answer development questions using NONMEM and/or Monolix with R for data handling, diagnostics, and simulation
• Serve as PMx lead on assigned programs
• Author analysis plans and modeling reports to regulatory submission standard
• Own analyses end to end
• Provide scientific input on dose, regimen, patient population, and development strategy
• Perform dose justification and exposure-response analyses
• Respond to health authority questions
• Perform quality control and quality review of modeling deliverables
• Support scientific oversight of vendor-delivered analyses
• Partner with PK/PD project leaders on quantitative strategy
• Build cross-functional networks across statistics, regulatory, medical, ADME, toxicology, and clinical development
• Present work at department forums and scientific project reviews
• Use and extend the department's automation stack
• Contribute to shared tooling, templates, and standards
• Communicate quantitative results to project teams and senior partners
• Share work through scientific meetings, publications, and regulatory interactions

Requirements

• PhD in pharmacometrics, population pharmacokinetics/pharmacodynamics, computational sciences, engineering, chemistry, statistics, or a related modelling area
• Experience in population PK and/or PK/PD modeling
• Thorough understanding of pharmacokinetic and/or pharmacodynamic principles
• Ability to clearly communicate theories and concepts to specialist and non-specialist audiences
• Experience using NONMEM or Monolix, R, and mrgsolve
• Hands-on experience across the full modeling workflow, including dataset specification and creation, exploratory data analysis, covariate evaluation and modeling, model evaluation, simulation, and reporting
• Experience contributing to a regulatory submission or health authority response
• Reproducible analysis practice, including Git and literate reporting such as Quarto
• Active engagement with AI and automation in a pharmacometrics context
• Comfort working when the question is not yet fully defined and willingness to propose the approach
• Ability to work with cross-functional colleagues
• Excellent self-management and organizational skills, with ability to prioritize across several programs

Core Competencies

Demonstrates expertise in population pharmacokinetics and pharmacodynamics modeling, utilizing tools such as NONMEM, Monolix, and R for comprehensive data analysis and regulatory submissions. Capable of leading cross-functional collaborations and effectively communicating complex quantitative results to diverse audiences.

Highest-signal resume keywords

• PhD In Pharmacometric
• Population PK/PD Modeling
• NONMEM
• Monolix
• R

ATS Optimization Keywords

Hard Skills

• Population PK Modeling
• PK/PD Modeling
• Data Handling
• Exploratory Data Analysis
• Model Evaluation
• Simulation
• Dose Justification
• Exposure-Response Analysis
• Reproducible Analysis Practice
• Covariate Evaluation

Soft Skills

• Excellent Self-Management
• Organizational Skills
• Clear Communication

Industry Keywords

• Pharmacokinetics
• Pharmacodynamics
• Regulatory Submission
• Health Authority Response
• Cross-Functional Collaboration

Tools & Technologies

• NONMEM
• Monolix
• R
• Mrgsolve
• Git
• Quarto