加入中美瑞康
共同打造创新型小核酸药物

工作地点: 上海, 苏州

汇报对象: 临床开发副总裁

职位概览

中美瑞康（Ractigen Therapeutics）正在寻找一位技术娴熟且善于分析的（高级）临床药理经理。作为临床开发团队的关键成员，您将负责连接我们新型RNA疗法的发现与临床应用。

您将负责设计和分析PK/PD策略，管理生物分析供应商，并确保我们的剂量选择和研究设计以数据为驱动且符合法规要求。该职位要求对定量药理学有深刻理解，并具备跨部门协作能力，以推动临床项目进展。

核心职责

1. 临床策略与研究设计

• 临床前至临床转化： 评估临床前体外ADME、PK/PD以及毒理学/毒代动力学数据，以支持稳健的临床试验设计。
• 研究设计： 设计、解读并报告临床PK/PD研究。为指定项目提供临床药理学专业支持，以表征药物的药理学特性。
• 剂量依据： 运用建模与模拟 (M&S) 技术，为临床试验中的剂量和给药方案选择提供科学依据。

2. 执行与数据分析

• PK/PD 分析： 执行房室和非房室分析；定稿PK研究报告及PK/PD综合报告。
• 供应商管理： 管理并与生物分析CRO合作，监督PK和生物标志物的方法开发、验证及样本分析，确保高质量且按时交付。

3. 法规与文档

• 医学撰写： 参与起草和审核临床开发计划、方案、临床研究报告 (CSR)、研究者手册 (IB) 以及产品标签中的临床药理学内容。
• 注册申报： 支持监管申报，并准备针对卫生监管机构（如NMPA, FDA, ICH）关于DMPK和临床药理学问题的回复。

4. 领导力与沟通

• 跨职能协作： 作为临床药理学的主要代表，与跨学科团队及外部顾问进行协作。
• 学术传播： 撰写稿件和会议海报；必要时在内部和外部提供临床药理学主题培训。

任职资格

1. 学历： 临床药理学、定量药理学、药代动力学或相关学科硕士及以上学位。
2. 经验：
   • 至少 3年 制药行业临床药理学工作经验，或
   • 5年以上 临床前及临床药理学综合工作经验。
3. 专业技能：
   • 深入掌握PK/PD原理、定量药理学分析及临床研究概念。
   • 熟练使用标准的PK及建模软件（如 WinNonlin, NONMEM, R）。
   • 熟悉NMPA, FDA及ICH的相关法规指南。
4. 综合素质：
   • 具备较强的沟通能力和团队合作精神。
   • 语言： 具备良好的英语听说读写能力。

工作地点: 苏州, 合肥

职位概览

中美瑞康正在寻找各个层级（从高级科学家到总监）的优秀人才加入我们的研发团队。根据您的经验，您将担任项目负责人 (Project Lead) 或治疗领域负责人 (Therapeutic Area Lead)，主导药物研发项目，涵盖从靶点评估、立项、临床前概念验证 (POC) 到 IND申报的全过程。

核心职责

1. 项目与战略领导力

• 科学家/高级科学家： 担任项目的技术骨干；设计并执行体外和体内实验以验证靶点及筛选RNA候选物。
• 副总监 (Associate Director)： 担任项目负责人；独立提出新药研发立项建议，设计PCC（临床前候选化合物）筛选的关键路径，并管理跨部门资源以确保项目按时推进。
• 总监 (Director)： 担任治疗领域负责人；制定特定疾病领域（如CNS、代谢、肿瘤）的研发战略；监管从概念到IND申报的整个管线；管理并指导科学家团队。

2. 项目执行：生物学与药理学

• 靶点发现： 通过文献调研和生物信息学分析，识别并提出适合小核酸药物包括RNA激活 (saRNA)和干扰 (siRNA) 的新颖靶点。
• 验证与筛选： 开发稳健的细胞水平分析方法（qPCR, WB, ELISA, 功能实验），用于验证靶点结合及寡核苷酸序列筛选。
• 体内药理学： 设计并监督动物药效学研究；分析PK/PD关系以指导剂量选择和优化。

3. 临床前开发与IND申报

• 主导项目从发现阶段向开发阶段的转化。
• 设计并管理IND-enabling研究（GLP毒理、安全药理、生物分布），与内部团队及外部CRO紧密合作。
• 撰写和审核向NMPA、FDA提交的注册申报资料（IND/CTA）中的药理/生物学部分。

任职资格

• 学历： 药理学、生物学或生物医学相关专业 Ph.D. 学位。具有博士后 (Postdoc) 培训经历者优先。
• 经验要求：
  • 科学家： 0-4年博士后/工业界经验。
  • 副总监： 5-8年工业界经验，具有带领项目至先导化合物优化阶段的记录。
  • 总监： 8年以上工业界经验，具有成功推进项目至 IND申报 的经验，并具备团队管理经验。
• 专业技能：
  • 核酸药物经验： 有寡核苷酸药物 (ASO, siRNA, saRNA) 研发经验者为加分项。
  • 语言能力： 必须具备优秀的英语听说读写能力，能够撰写高质量的科学报告并进行流利的学术交流。

申请方式

请将您的中英文简历 及求职信 (Cover Letter) 发送至：hr@ractigen.com

(请务必在邮件或求职信中注明您申请的职级：科学家 / 副总监 / 总监)

Job Location:Suzhou

Report to: CTO

Position Overview:

Ractigen Therapeutics is a global leader in the development of Small Activating RNA (saRNA) therapeutics. We are seeking a highly motivated and experienced Director of Neuroscience to build and lead our CNS discovery pipeline.

The successful candidate will lead the biological strategy for treating neurodegenerative and neuromuscular diseases by exploiting Ractigen’s diverse oligonucleotide platforms. This role requires deep expertise in neurobiology and RNA therapeutics, with a mandate to develop interventions that modulate gene expression (via both upregulation and silencing mechanisms) to address complex CNS disease drivers.

Key Responsibilities:

1. CNS Pipeline Strategy & Leadership

• Define and execute the strategic roadmap for Ractigen’s neuroscience portfolio. Identify high-value targets where RNA-based modulation—whether restoring expression of a haploinsufficient gene or silencing a toxic gain-of-function mutation—offers a distinct therapeutic advantage.
• Lead a team of scientists to drive projects from Target Identification & Validation through Lead Optimization, to Candidate Selection (PCC) and IND filing.
• Serve as the primary biology lead for CNS programs, making data-driven Go/No-Go decisions based on molecular biology, pharmacology, and safety data.

2. Pharmacology & In Vivo Biology

• Design and oversee robust in vitro and in vivo proof-of-concept studies to demonstrate target engagement and the desired functional outcome and phenotypic rescue.
• Establish and validate relevant cellular (iPSC-derived neurons) and animal models for neurodegenerative diseases (e.g., ALS, Alzheimer’s, CNS genetic disorders).
• Delivery Validation: Collaborate closely with the Chemistry/Delivery team to evaluate novel CNS delivery systems, including conjugates (AOCs/ligands) for systemic delivery and formulations for intrathecal (IT) or intracerebroventricular (ICV) administration.

3. PK/PD & Translational Medicine

• Design studies to characterize the Pharmacokinetics (PK) and Pharmacodynamics (PD) of oligonucleotides in the CNS (brain tissue distribution, CSF dynamics, intracellular uptake).
• Develop translatable biomarkers to facilitate the transition from preclinical research to clinical development.

4. External Collaboration & Management

• Manage relationships with CROs for specialized neuro-behavioral studies, histology, and safety assessments.
• Represent Ractigen in scientific meetings and collaborations with academic or industry partners.

Qualifications:

1. Education: Ph.D. in Neuroscience, Neuropharmacology, or a related biological science.
2. Experience:
   • 6+ years of drug discovery experience in the biotech or pharmaceutical industry, with at least 2 years in a leadership role.
   • Essential: Direct experience with Nucleic Acid Therapeutics (siRNA, ASO, or saRNA) in the CNS context.
3. Technical Expertise:
   • Deep understanding of neuroanatomy and neurodegenerative disease mechanisms.
   • Proven track record in managing CNS delivery studies (e.g., IT/ICV dosing techniques, biodistribution analysis).
   • Experience with BBB penetrating technologies (e.g., receptor-mediated transport) is a significant plus.
4. Leadership: Strong ability to lead cross-functional teams and mentor junior scientists in a fast-paced, innovative environment.

Job Location: Suzhou

Report to: CEO

Position Overview:

Ractigen Therapeutics is a clinical-stage biotechnology company pioneering the development of saRNA (small activating RNA) therapeutics. We are seeking a visionary Vice President of Oligonucleotide Chemistry to architect the future of our chemical platform.

In this strategic leadership role, you will architect the roadmap for next-generation RNA chemistry. You will drive proprietary innovations in oligonucleotide modification to enhance the therapeutic index of our molecules. Crucially, you will pioneer our Targeted Delivery Platform, spearheading the development of Antibody-Oligonucleotide Conjugates (AOCs) and other ligand-directed technologies to overcome the barriers of extra-hepatic delivery and enable precision tumor targeting

Key Responsibilities:

1. Innovation in Nucleic Acid Chemistry

• Novel Modifications: Lead the design and synthesis of proprietary chemical modifications (sugar, base, and backbone chemistries) to enhance the potency, metabolic stability, and safety profile of saRNA, minimizing off-target effects and immunogenicity.
• Platform Evolution: Benchmark against industry standards (e.g., cEt, LNA, MOE, 2’-F/2’-OMe patterns) to develop a differentiated, best-in-class chemical platform.

2. Delivery Platform & Bioconjugation (Strategic Focus)

• AOC Strategy: Spearhead the development of AOCs. Design stable and cleavable linker chemistries to enable precise, cell-specific delivery of RNA payloads using antibodies or Fabs.
• Ligand-Drug Conjugates (LDC): Expand the delivery toolkit beyond GalNAc. Direct the design of novel ligands (lipids, peptides, small molecules) to target extra-hepatic tissues (e.g., CNS, muscle, adipose tissue, tumor).

3. R&D Strategy & Pipeline Leadership

• SAR/SPR Leadership: Oversee the establishment of robust Structure-Activity Relationships (SAR) and Structure-Property Relationships (SPR) to rapidly cycle from hit-to-lead to candidate selection.
• Scalability & CMC: Ensure that novel chemistries and conjugates are designed with scalability in mind. Collaborate with CMC teams to transition molecules from discovery scale (mg) to process development (g/kg).
• Cross-Functional Integration: Work closely with Biology, DMPK, and Toxicology VPs to align chemical innovation with biological performance and safety requirements.

4. Intellectual Property & External Collaboration

• IP Estate: Aggressively expand Ractigen’s intellectual property portfolio by patenting novel chemical entities, linkers, and conjugation platforms.
• Partnerships: Evaluate and manage high-level collaborations with CDMOs, academic partners, or biotech partners for licensing novel delivery technologies.

Qualifications:

1. PhD in a biological or pharmaceutical-related field with over 8 years of business development experience in the biotech or pharmaceutical industry, including a proven track record of successful in-licensing/out-licensing deals.
2. Experience in developing and executing business development strategies that contribute to company growth.
3. Strong scientific acumen, analytical mindset, and deep familiarity with the drug discovery and development process.
4. Proven ability to craft compelling business narratives and develop high-impact BD materials that resonate with stakeholders.
5. Self-driven with strong problem-solving, collaboration skills, and a keen ability to identify and capitalize on business opportunities.
6. Excellent organizational and time management skills, with the ability to interact effectively with potential partners, internal teams, and senior management.
7. Exceptional English communication and presentation skills, with the ability to influence internal and external stakeholders.