锦鲤求职岗位描述
We are seeking an experienced Senior Principal Scientist /Associate Director to independently conduct quantitative pharmacology modeling and simulation work covering early preclinical research and late-stage clinical development. The incumbent will provide critical scientific evidence for dose optimization, clinical decision-making and regulatory submission.
Key Responsibilities
• Modeling & Simulation: Independently conduct full-spectrum quantitative pharmacology analysis including population PK (Pop-PK), PK/PD, exposure-response (E-R) including QTc and PBPK modeling and simulation and the routine NCA analysis. Deliver complete analytical reports, perform model validation, dose prediction and dosage regimen optimization.
• Early-Phase FIH Project support: form quantitative pharmacology strategy for first-in-human (FIH) studies. Independently execute IND-stage MRSD/MABEL dose calculation, dose-escalation design, SAD/MAD trial support, and determine RP2D to mitigate early clinical risks.
• Late-Phase Clinical Project support: Lead quantitative pharmacology activities for Phase II dose-finding studies, optimal dose determination, and Phase III confirmatory trials. Conduct dose extrapolation for general and special populations, exposure-efficacy and exposure-safety analysis to support pivotal clinical development and indication approval.
• Technical Leadership: Oversee team technical delivery, report review and collaborate cross-functionally to drive clinical project execution and support pipeline portfolio evaluation and risk assessment.
Qualifications
• Education: Master’s degree or above in Pharmacology, Clinical Pharmacology, Quantitative Pharmacology, Pharmacy, Biostatistics or related disciplines; PhD is highly preferred.
• Professional Experience: 5+ years of industry experience in quantitative pharmacology / clinical pharmacology for innovative drug development, with 2+ years in a technical lead or project leadership role. Proven independent experience in delivering full-cycle projects covering FIH early-phase and Phase II/III late-phase clinical programs with successful project execution and regulatory submission track records.
• Core Competencies: Capable of independent end-to-end quantitative pharmacology modeling. Proficient in one of population PKPD tools such as Phoenix NLME, NONMEM, Monolix, PBPK platforms (GastroPlus/Simcyp),Phoenix WinNonlin, and R, a. Familiar with global CDE/FDA guidelines. Able to independently resolve technical challenges and support regulatory defense.
• Preferred Qualifications: Experience with small molecules, biologics, targeted innovative drugs, or global multi-center clinical trials is a strong plus.
• Soft Skills: Excellent project leadership, cross-functional communication and project management skills. Rigorous scientific mindset, strong compliance awareness, and proficient English written and verbal skills.