锦鲤求职岗位描述
岗位职责
Lead the translational modeling strategy for assigned programs: define the M&S plan from discovery
through late-stage development, and integrate PK, target engagement, biomarker, efficacy, and safety
data into a coherent quantitative framework.
• Build translational PK/PD models linking exposure, target occupancy/engagement, PD biomarkers, and
efficacy across species; perform interspecies scaling and animal-to-human translation to project the
human efficacious dose and exposure.
• Support first-in-human dose selection and justification (MABEL, PAD, MRSD, NOAEL-based approaches)
and design of dose-escalation schemes, including model-based escalation designs.
• Develop population PK models (NONMEM / R) and exposure–response models for efficacy and safety to
• support dose selection, dose justification, covariate and special-population assessment, and labeling.
• Conduct concentration–QTc analysis in line with ICH E14/S7B (including the Q&A on concentration–QTc
modeling) to support cardiac safety assessment, and integrate nonclinical cardiac safety data where
applicable.
• Develop and apply PBPK models to address drug–drug interaction, organ impairment, food effect and
formulation questions, pediatric extrapolation, and tissue/target-site distribution.
• Build QSP / systems pharmacology and disease progression models to support target validation,
indication selection, combination strategy, and long-term outcome projection.
• Perform clinical trial simulation to optimize dose, regimen, study duration, sample size, and PK/PD
sampling schedules; support adaptive, seamless, and biomarker-driven designs.
• Author the modeling and clinical pharmacology sections of regulatory documents (IND/IB, protocols,
briefing packages, CSRs, Summary of Clinical Pharmacology and Module 2.7.2, MIDD packages) for CDE,
FDA, EMA, and PMDA, and lead responses to regulatory questions on M&S.
• Present model-based recommendations to project teams, governance committees, and health
authorities, and translate complex quantitative results into clear, actionable development decisions.
• Manage and technically oversee external modeling vendors and CROs; contribute to reproducible,
version-controlled, and well-documented modeling workflows and internal standards.
岗位要求
• Ph.D. or M.S. with 3+ years of industry experience in translational medicine, pharmacometrics, systems
pharmacology, biomedical engineering, applied mathematics/statistics, or a related quantitative
discipline.
• Strong hands-on nonlinear mixed-effects modeling expertise: NONMEM (with PsN) and/or R for data
assembly, diagnostics, simulation, and reporting (e.g., tidyverse, ggplot2, xpose, mrgsolve/RxODE,
nlmixr).
• Demonstrated translational modeling experience — mechanistic and empirical PK/PD modeling of
preclinical data, cross-species scaling, and preclinical-to-clinical projection of dose and exposure,
including first-in-human dose estimation.
• Hands-on experience developing population PK and exposure–response models from real clinical data,
including covariate model building, model evaluation (VPC, bootstrap, pcVPC), and simulation-based
dose justification.
• Practical experience in at least two of the following, with the ability to grow into the others:
concentration–QTc modeling; PBPK (Simcyp, GastroPlus, PK-Sim/MoBi, or equivalent); QSP or disease
progression modeling (ODE-based platforms such as SimBiology, mrgsolve, Berkeley Madonna, or
custom code).
• Experience authoring modeling reports and regulatory documents, and familiarity with FDA, EMA, and
NMPA/CDE guidance on population PK, exposure–response, PBPK, MIDD, and ICH E14/S7B.
• Sound understanding of pharmacology, physiology, and drug development strategy, with the judgment
to choose the simplest model that answers the question.
• Excellent verbal and written communication skills in both English and Chinese, with a track record of
influencing cross-functional decisions using quantitative evidence.