锦鲤求职岗位描述
岗位职责
1. Health Authority Interactions & Regulatory Defense (FDA, EMA & NMPA)
•Serve as the primary technical presenter and defender for the pharmacometrics and clinical pharmacology package during formal milestone meetings with the U.S. FDA (e.g., End-of-Phase 2, Pre-NDA, Advisory Committee hearings), EMA and the China NMPA（CDE consultations）.
•Lead the rapid strategy, execution, and authoring of technical responses to real-time Health Authority Information Requests （IR） and deficiency letters during active global NDA reviews.
•Negotiate directly with regulatory reviewers regarding modeling assumptions, covariate selections, and simulation protocols to secure favorable global product labeling and dosing mandates.
2. Global NDA/NDA-Equivalent Submission Package Ownership
•Author and review critical regulatory eCTD modules, including Module 2.7.2 （Summary of Clinical Pharmacology） and Module 5.3.3.2 (Pharmacometrics Reports), optimizing technical data presentation for concurrent global submissions.
•Oversee the design, validation, and delivery of CDISC-compliant modeling datasets (SDTM/ADaM, explicitly ADPC and ADPP domains) ensuring exact alignment with both FDA data specifications and NMPA filing standards.
•Develop and execute global clinical pharmacology filing strategies, harmonizing multi-regional clinical trial data （MRCTs） to satisfy the distinct regulatory paradigms of western and eastern regulatory bodies.
3. Advanced Computational Modeling & Simulation
•Personally write, debug, and execute complex modeling scripts using non-linear mixed-effects modeling frameworks to characterize population pharmaceutics (PopPK) and complex PK/PD relationships.
•Develop sophisticated exposure-response (E-R) models for continuous, categorical, and time-to-event （TTE） endpoints to optimize risk-benefit profiles for dual agency review.
岗位要求
1. Global Regulatory & Submission Experience
•Direct, verifiable track record of owning the pharmaceutics data package for successful U.S. NDA and/or China NDA submissions.
•Hands-on experience participating in formal, face-to-face or virtual technical panels and briefing reviews with FDA, EMA and NMPA/CDE officials.
•Strong comprehension of multi-regional drug development programs, including ethnic sensitivity evaluation paradigms and multi-regional clinical trial geometries (MRCTs).
2. Technical & Computational Competencies
•Advanced, expert-level mastery of core pharmaceutics software platforms: NONMEMBER (including Perl-speaks-NONMEM/PsN, Pirana), Monolix, R (specifically tidyverse, brms, ggplot2, and specialized PK/PD packages), and Phoenix WinNonlin.
•Deep computational knowledge of estimation algorithms, including FOCE+I, SAEM, IMPMAP, and Bayesian Markov Chain Monte Carlo (MCMC) simulations.
3. Linguistic Skills (Mandatory)
•Professional fluency in English and Mandarin Chinese is required. Candidates must possess a proven capability to read, write, and debate technical coding, clinical, and regulatory scenarios naively in both languages to bridge the U.S. team and our Suzhou campus.
4. Professional Experience & Education
•8+ years of bio pharmaceutical industry experience explicitly focused on quantitative clinical pharmacology and pharmaceutics modeling.
•Therapeutic expertise in oncology or hematology, specifically mapping exposure-safety and exposure-efficacy modeling for small-molecule targeted therapies or apoptotic pathways.
•PhD., P harm. D., or MD in Pharmaceutics, Pharmaceutical Sciences, Biomedical Engineering, Bio statistics, or a heavily quantitative biological/computational discipline is required.