Job Description

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

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.

Nice-to-have:

Experience supporting translational or clinical pharmacology leads in dose justification. Familiarity with integrating nonclinical PK/PD data (2-species GLP human FIH extrapolation).

Experience level

~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.

Expectations

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).

Inputs we give:

PK/PD datasets, tox summaries, and performance prompts (e.g., "fit exposure-response curves, interpret safety margins"). Example model outputs from automated systems.

Expected outputs:

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.

Engagement Model & Compensation

*

Contract / part-time

, remote, outcome-based deliverables.