This person complements the client’s “Translational / Clinical Pharmacology Decision-Maker” team by grounding dose selection and exposure–response analysis in quantitative structure and parameter plausibility.
Who We’re Looking For
Who We’re Looking For
- Deep hands-on experience in PK, PD, exposure–response modeling, and ideally population PK or QSP.
- Expert at model fitting, sensitivity analysis, and identifying non-plausible parameter spaces.
- Can evaluate the validity of dose–exposure predictions and detect high-risk extrapolations.
- Comfortable designing model evaluation rubrics that distinguish between acceptable vs. non-credible outputs.
- Able to articulate how quantitative checks should complement narrative decision logic.
- Experience supporting translational or clinical pharmacology leads in dose justification.
- Familiarity with integrating nonclinical PK/PD data (2-species GLP → human FIH extrapolation).
- :8–12 years of quantitative pharmacology experience in pharma, CROs, or modeling consultancies.
- Strong portfolio in population PK/PD, exposure–response, and parameter estimation using NONMEM, Monolix, or equivalent tools.
- Demonstrated ability to interpret model results for decision-making, not just fit data.
- Can create fit-for-purpose models and critique model structures or assumptions under uncertainty.
- Design and refine micro-evaluations for PK/PD performance (curve fits, parameter checks, error taxonomies).
- Encode quantitative sanity checks into model rubrics for automated evaluation.
- Define failure conditions (e.g., unsafe extrapolation, poor coverage curves, invalid assumptions).
- PK/PD datasets, tox summaries, and performance prompts (e.g., “fit exposure–response curves, interpret safety margins”).
- Example model outputs from automated systems.
- Quantitative Rubrics: clear thresholds for acceptable parameter fits, coverage curve quality, and model integrity checks.
- Golden Fit Examples: representative “ideal” PK/PD model outputs and visualizations for calibration.
- Error Taxonomy: structured list of typical modeling or fitting errors, with root-cause annotations.
- Meta-Layer Commentary: short note per rubric capturing how expert modelers recognize implausible or unsafe fits beyond numeric error values.
- Contract / part-time, remote, outcome-based deliverables.