Medical AD/D/SD
USA/上海 Clinical Development1. Lead clinical development. Provide clinical as well as general medical expertise throughout developments, from clinical development plan, protocol development through study conduct, regulatory submission(s) and product launch.
2. Provide expert input to the clinical studies and provide oversight of protocol development, in collaboration with partner’s global teams (if applicable)
3. Responsible for protocols to identify region-specific operational issues for the territory. Where necessary, provide medical oversight of clinical project
4. Perform as medical monitor or oversight for CRO partners on medical queries and issues
5. Provide medical expertise in interactions with regulatory agencies
6. Attend investigator meetings; deliver clinical presentations as needed
7. Oversight vendors as needed to ensure successful clinical studies for regulatory submission goal
8. Proactively identify key investigators in the region and cultivate long-term collaborations. Recruit and manage regional Clinical Advisory Board if needed
9. Establish and maintain appropriate collaborations and relationships with external scientific experts, thought leaders, and the general medical community
1. Medical Doctor degree or Master degree of relevant therapeutic area
2. 5+ years of clinical development or pharmaceutical medical function experience
3. Previous experiences in IND/NDA submission and interacting with regulatory authorities preferred
4. Good communication skills and presentation skills
5. Fluent English in written and verbal
Clinical Operation AD/D/SD
USA Clinical Development1. Fully responsible for the execution of assigned projects, ensure project deliverables of high quality according to the endorsed timeline, budgets and applicable regulations and guidelines, and ensure the conduct and results of clinical trials to be accepted by relevant regulatory authorities.
2. As a key coordinator of the project team, organize and coordinate project team members across various departments, develop and confirm relevant project plans and budgets, provide oversight of project execution, and ensure timely and high-quality deliverables per timeline.
3. As the key contact point of the project, responsible for internal and external communication and coordination, timely updating the progress of the clinical trial project and/or related issues identification and solutions.
4. Lead the project team to perform clinical trial feasibility, clinical trial site selection, site initiation, enrollment, data management and database lock, as well as site closeout etc.
5. Responsible for vendor selection and management for the project, including CRO, SMO, central laboratory, drug and non-drug supply, subject recruitment, etc.
6. Responsible for collection, update, and archive of clinical trial documents (including but not limited to essential documents) to satisfy the requirements of GCP and applicable regulations.
7. Provide updates on regulations and guidelines related to clinical trials and assistance to other relevant functions of the company from clinical operational perspective.
8. Be responsible for resource planning, team recruitment and performance assessment of the department, formulate a reasonable resource allocation model, and improve team efficiency if needed.
9. If needed, provide training and coaching within the department or as a mentor as well as develop career development plans for direct reports.
10. Complete other tasks if applicable.
1. Bachelor's degree or above, in life sciences, pharmacy, nursing, etc.
2. Familiar with and full knowledgeable in the relevant regulations of clinical trials and GCP and other applicable guidelines.
3. 10 or more years of relevant work experience in project management of early and late phase clinical trials and the pharmaceutical industry, familiar with systems commonly used in clinical trials (e.g. EDC、eTMF)
Portfolio Project Management AD/D
上海 Clinical Development1. Supervise and manage the company's pipeline and projects under development to ensure that their progress aligns with the company's strategic goals.
2. Develop and implement pipeline and project management methods, processes, and practices, and continuously optimize them.
3. Coordinate the allocation of project resources across all relevant departments such as Research Department, CMC, QA, Preclinical Department, and Clinical Development Department, manage the financial and material resources required for the project, including budget preparation and cost control, optimize resource allocation, and improve resource utilization efficiency.
4. Develop project plan, monitor project progress, and regularly update project status.
5. Manage project timelines effectively, ensure the reasonable setting and strict adherence to key project milestones, coordinate cross departmental cooperation, accelerate research and development speed, avoid project delays, and adjust project schedules as necessary to address unforeseen challenges.
6. Identify potential risks in the project and develop a risk mitigation plan. Monitor risk factors and take timely measures to reduce the impact on the project
7. Ensure project management complies with industry standards, law, regulatory requirements, and company internal control policies
8. Communicate effectively with cross departmental teams to effectively advance project progress, and regularly report project status and performance to senior management and stakeholders. 9.Complete other tasks assigned by superiors.
1. Bachelor's degree or above, in life sciences, pharmacy, clinical or chemistry, etc.
2. Familiar with and full knowledgeable in the relevant regulations of clinical trials and GCP and other applicable guidelines.
3. At least 5 years of experience in innovative drug management and project management, with at least one complete project management practice from IND to NDA
Clinical Pharmacology SM/AD
上海 Clinical Development1. 整合分析临床前药效、DMPK 和毒理数据，调研综合同类靶点药物临床药理相关数据，与临床团队合作；
2. 协助完成临床药理试验研究方案设计，负责 PK 和 PK/PD 数据的解读和整理；
3. 开展 PK/PD 建模与 popPK/PD 分析，整合临床前及临床数据，预测人体内的药效反应及剂量-暴露-效应关系；
4. 基于系统性文献调研，跟踪和整合前沿建模方法（如 siRNA 递送机制、靶向介导药物动力学模型等），优化公司内部建模策略；
5. 完成临床研究启动阶段的相关资料准备，包括竞品药物调研、模型分析综述及主要终点指标的选择依据；
6. 支持 IB, protocol 等资料中临床药理相关部分的审阅和撰写；
7. 协助完成临床开发计划、临床试验方案、IND 和 NDA 申报资料等临床药理相关内容的攥写；
8. 与临床、生物分析及临床前团队协作，探索生物标志物与临床终点之间的关联性，支持后续的模型开发；
9. 参与生物标记物的选择、验证方案结果解读；
10. 竞品分析和监管政策解读；
11. 遵守各项规章制度和完成上级领导安排的其他工作。
1. 博士（药学、药理学、生物工程、计算生物学等相关领域，3年以上）或硕士+显著行业经验（5年以上）；
2. 1. 5年以上群体PK/PD建模经验，熟悉NONMEM、Phoenix、R/Python等工具
3. 全程参与至少1个创新药临床开发项目（I-III期），熟悉监管要求（FDA/EMA）
Antibody&Antibody Conjugate Development Senior Scientist
上海 R&D1. Function as a key team member in antibody discovery, optimization, formatting, developability evaluation, bioconjugation and characterization.
2. Work with process development group to establish SOPs for antibody production, bioconjugation and downstream processing.
3. Establish and optimize infrastructure for the development of antibody-oligonucleotide conjugates.
4. Work with internal cross functional team and external partners, identify or develop appropriate assays to support development of antibody-oligonucleotide conjugates.
5. Stay current with the state-of -the-art of targeted oligonucleotide delivery technologies and drive scientific innovation in the field. Identify and validate antibody-based delivery targets. Mechanistic investigation into the delivery mechanisms and continue to iterate and improve.
6. Mentor and guide team members, foster a collaborative and high-performing research environment within the team. 7.Complete other tasks assigned by the superior.
1. PhD in Biology, biomedicine, or a related field with minimal 3 years of relevant experience in biotech or pharmaceutical industry, with demonstrated track record in basic research and significant contributions to drug discovery.
2. Prior experience in antibody-based drug discovery programs is a must. Proficient in antibody discovery, optimization, formatting, developability assessments.
3. Experienced in downstream processing of antibody and antibody conjugates and scale up.
Senior Scientist Antibody and Antibody Conjugate Development
上海 R&DLeadership and Management:
Lead and mentor a team of scientists and engineers, fostering a collaborative and high-performing environment.
Oversee the planning, execution, and evaluation of biologics and AOC development and manufacturing activities.
Develop and implement strategic plans for cell line development and downstream process development, ensuring alignment with overall company objectives.
Process Development and Characterization:
Develop and optimize manufacturing processes for antibody and AOC drug substances, including upstream (cell line development, cell culture) and downstream (bioconjugation, antibody and AOC purification) activities.
Lead process characterization studies to ensure robustness and scalability.
Develop and validate analytical methods for in-process testing.
Manufacturing and Tech Transfer:
Develop and implement manufacturing strategies for both clinical and commercial scale.
Manage tech transfer activities between CDMOs, ensuring smooth transitions and scale-up.
Collaborate with CDMOs to ensure compliance with regulatory requirements.
Regulatory and Quality:
Author and review relevant sections of regulatory filings (INDs, BLAs).
Work with QA and QC to establish and maintain drug substance and product specifications.
Ensure adherence to relevant regulations (FDA, EMA, NMPA, ICH,GMP).
Risk Management:
Identify and mitigate risks associated with process development and manufacturing.
Develop and implement risk mitigation strategies.
Collaboration and Communication:
Work closely with cross-functional teams, including clinical, quality, and regulatory affairs.
Maintain effective communication with CDMOs and other stakeholders.
Author and review relevant sections of regulatory filings (INDs, BLAs).
Work with QA and QC to establish and maintain drug substance and product specifications.
Ensure adherence to relevant regulations (FDA, EMA, NMPA, ICH,GMP).
Risk Management:
Identify and mitigate risks associated with process development and manufacturing.
Develop and implement risk mitigation strategies.
Collaboration and Communication:
Work closely with cross-functional teams, including clinical, quality, and regulatory affairs.
Maintain effective communication with CDMOs and other stakeholders.
Qualification Requirement:
Education: Ph.D. in a relevant scientific discipline (e.g., chemistry,biochemistry, molecular biology) with a strong background in process development or manufacturing.
Experience: 10+ years of extensive experience in antibody, AOC or ADC process development, including upstream and downstream processing, process characterization, validation, and manufacturing.
Senior/Principle Scientist, Biology（Kidney Disease）
上海 R&D1. Design and optimize kidney-targeted delivery systems to enhance kidney-specificity and efficacy of siRNA drugs. Mechanistic investigation into the delivery mechanisms and continue to iterate and improve.
2. Design and execute in vitro/in vivo experiments to advance oligonucleotide drug targeted delivery and discovery programs.
3. Utilize molecular, cellular, and biochemical techniques to identify and validate novel therapeutic targets for chronic kidney diseases.
4. Function as biology lead to drive drug discovery programs from inception to clinical candidate, support clinical development and external collaborations.
5. Analyze and interpret complex data sets and present findings to internal and external stakeholders.
6. Collaborate with cross-functional teams, including informatics, drug discovery, and clinical development, to advance research programs.
Stay current with scientific literature and emerging technologies in the fields of kidney diseases, metabolic disorders, cardiorenal syndrome and related areas.
7. Contribute to the preparation of scientific publications, patents, and regulatory documents.
8. Supervise and train associates or junior scientists, foster a collaborative and high-performing research environment within the team.
9. Maintain accurate and detailed laboratory records and ensure compliance with company policies and regulatory requirements.
10. Complete other work assigned by the leader.
1. PhD in Physiology, Molecular Biology, Pharmacology, or a related field with a minimum of 4 years in biotech or pharmaceutical industry, with demonstrated track record in basic research and significant contributions to drug discovery or technology development.
2. Prior experience in receptor-mediated extrahepatic delivery of oligonucleotides is highly preferred.
3. Strong background in chronic kidney disease research and knowledge in metabolic disease and cardiorenal syndrome are preferred.
Senior Scientist, Biology（Heart Disease）
上海 R&D1.Design and optimize cardiac-targeted delivery systems to enhance cardiac-specificity and efficacy of siRNA drugs.
2.Design and execute in vitro/in vivo experiments to advance oligonucleotide drug targeted delivery and discovery programs.
3.Utilize molecular, cellular, and biochemical techniques to identify and validate novel therapeutic targets for heart failure/cardiomyopathy.
4.Analyze and interpret complex data sets and present findings to internal and external stakeholders.
5.Collaborate with cross-functional teams, including informatics, drug discovery, and clinical development, to advance research programs.
6.Stay current with scientific literature and emerging technologies in the fields of heart failure/cardiomyopathy, metabolic disorders, cardiorenal syndrome and related areas.
7.Contribute to the preparation of scientific publications, patents, and regulatory documents.
8.Supervise and train associates or junior scientists.
9.Maintain accurate and detailed laboratory records and ensure compliance with company policies and regulatory requirements.
1.PhD in Physiology, Molecular Biology, Pharmacology, or a related field.
2.Strong background heart failure/cardiomyopathy research and knowledge in metabolic disease and cardiorenal syndrome are preferred.
3.Hands-on experience with preclinical models of heart failure/cardiomyopathy and molecular techniques.
4.Good understanding and experienced in various biophysical assays and cell-based assays such as but not limited to receptor binding, internalization and cycling, ITC, BLI, SPR, etc.
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