一、职位概述 / Position Summary
我们正在寻找一位具有前瞻性视野和深厚科学底蕴的高级医学负责人,全面主导公司创新药物管线(特别是针对呼吸系统疾病的小核酸药物及前沿疗法)从临床前向早期临床阶段的跨越。
该职位需要候选人具备“第一性原理”的底层科研思维,能够将早期的遗传学证据(如 LOF)和机制验证数据,无缝转化为具有洞察力的转化医学策略和 First-in-Human (FIH) 临床试验方案。您将作为核心驱动力,带领团队完成中美双报(FDA/NMPA)的 IND 冲刺,并成功取得 Phase I/Ib 期的概念验证(POC)数据。
We are seeking a scientifically rigorous and visionary Senior Director to lead the critical transition of our innovative pipeline (specifically oligonucleotide therapeutics and advanced modalities for pulmonary diseases) from pre-clinical research into early-stage clinical development.
This role requires a leader with a "First Principles" scientific mindset, capable of translating early genetic evidence and mechanistic data into highly insightful translational medicine strategies and First-in-Human (FIH) clinical protocols. You will be the core driver in leading the team through dual US/China (FDA/NMPA) IND filings and successfully achieving Phase I/Ib Proof of Concept (POC).
二、核心职责 / Key Responsibilities
1、早期临床战略与 FIH 设计 (Early Clinical Strategy & FIH Design): 领导从候选化合物 (PCC) 推进至 IND 及临床 I/Ib 期的医学战略。主导 First-in-Human (FIH) 试验方案的精巧设计,重点主导起始剂量爬坡策略 (Dose Escalation)、早期安全性评估矩阵以及药代/药效动力学 (PK/PD) 信号捕获。
Lead the medical strategy from Preclinical Candidate (PCC) nomination through IND and Phase I/Ib. Direct the elegant design of First-in-Human (FIH) protocols, with a strong focus on dose escalation strategies, early safety assessment matrices, and PK/PD signal capture.
2、深度转化医学探索 (Deep Translational Medicine): 填补早期研发与临床试验之间的转化鸿沟。针对核酸药物等大分子的肺部靶向递送特性,制定并验证前沿的临床生物标志物 (Biomarkers) 和靶点结合 (Target Engagement) 评价策略,建立精准的早期临床有效性评估体系。
Bridge the translational gap between early R&D and clinical trials. Specifically addressing the pulmonary delivery characteristics of nucleic acid therapeutics, develop and validate cutting-edge clinical biomarker and target engagement strategies to establish a precise early efficacy evaluation framework.
3、中美 IND 双报主导 (US/China IND Strategy & Execution): 作为核心医学负责人,主导中美双报(NMPA & FDA)临床相关申报文件(如 Clinical Overview、Investigator's Brochure)的撰写与科学审核;直接牵头与中美监管机构(如 CDE, FDA)的早期沟通会议(Pre-IND meeting),确保管线顺利且快速地进入临床阶段。
Act as the core medical lead for dual US/China (FDA/NMPA) regulatory submissions, directing the authoring and scientific review of clinical-related IND modules (e.g., Clinical Overview, IB). Spearhead early communications and Pre-IND meetings with global health authorities to ensure rapid and smooth clinical entry.
4、早期 BD 与顾问生态建设 (Early-Stage BD & KOL Ecosystem): 为公司的高价值早期资产 License-in/License-out 提供具有深度的医学尽调与价值评估;构建并维护由全球呼吸/肺部疾病基础科学家及早期临床 PI 组成的科学顾问委员会 (SAB)。
Provide in-depth medical due diligence and valuation for early-stage asset License-in/out opportunities; build and maintain a Scientific Advisory Board (SAB) comprising top-tier global basic scientists and early-clinical PIs in pulmonology/respiratory diseases.
任职要求:
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