臨床藥理學家(Clinical Pharmacologist) 專員/副理/經理

【職位簡介】 我們正在尋找一位經驗豐富的資深臨床藥理學專家，協助開發505(b)(2)藥品。此職位將負責設計與執行藥代動力學（PK）/藥效動力學（PD）研究、橋接策略及監管溝通，以支持NDA（新藥申請）遞交。理想人選需熟悉生物等效性（BE）、生物利用度（BA）、藥物-藥物相互作用（DDI）及特殊族群研究，並能有效支援產品開發與監管策略。 【主要職責】 • 設計並監督橋接試驗（Bridging Studies），以支持505(b)(2)法規申請，確保開發效率並減少臨床試驗需求。 • 執行並分析藥代動力學（PK）及藥效動力學（PD）研究，包括生物等效性、生物利用度及藥物-藥物相互作用試驗。 • 參與與FDA及其他監管機構的互動，協助準備pre-IND、pre-NDA會議的相關文件。 • 應用**PK/PD建模與模擬（PBPK、PopPK）**來優化處方或劑量選擇 • 協助仿單策略、藥物改良與產品生命周期管理。 【About the Role】 We are seeking a highly experienced Senior Clinical Pharmacologist to support the development of 505(b)(2) drug products. This role involves designing and executing PK/PD studies, bridging strategies, and regulatory interactions to support NDA submissions. The ideal candidate will have expertise in bioequivalence (BE), bioavailability (BA), drug-drug interactions (DDI), and special population studies. 【Key Responsibilities】 • Design and oversee bridging studies to support 505(b)(2) regulatory submissions, ensuring efficient development and reduced clinical trial requirements. • Conduct and interpret pharmacokinetic (PK) and pharmacodynamic (PD) studies, including bioequivalence, bioavailability, and drug-drug interaction trials. • Collaborate with regulatory teams to engage with the FDA and other health authorities, assist to prepare the required documents for pre-IND and pre-NDA meetings. • Utilize PK/PD modeling and simulation (PBPK, PopPK) to optimize formulation and dose selection. • Support labeling strategies, drug reformulation, and lifecycle management initiatives.