Job Description:

• 与药化，药效，毒理，CMC，非临床&RA，临床团队紧密合作，提供药代动力学与生物分析相关支持，参与药物发现与开发项目团队会议，在研发过程中从药代动力学角度提出合理建议。
• 负责临床前筛选与申报药代CRO的评估和筛选，以及临床生物分析CRO的评估和筛选。协调CRO，监督CRO有序高效推进工作。负责实验方案与正式报告审核修订，申报资料的审核修订，协助项目申报和临床实验开展。
• 根据临床前药代数据，建模预测人体药代参数，协助临床团队制定临床研究方案。参与审阅临床方案中临床药理药代相关部分实验设计，数据总结，报告撰写等。
• 采用液相色谱－质谱联用开发建立不同基质生物分析方法，进行生物样品分析，支持从临床前至临床相关的生物分析工作。

Qualification:

• 药代动力学相关专业，博士学位或硕士学位，且具备多年工业界药代动力学相关工作经验，硕士至少十年以上，博士至少三年以上。
• 具备体外ADME和体内PK研究的实践经验，熟悉药代动力学研究的专业知识和原理，熟悉PBPK，PK/PD建模者优先。
• 具有生物分析知识和仪器分析经验
• 具有良好的解决问题的能力，协调组织沟通能力以及团队合作精神。
• 具有良好的英语阅读与写作能力。

Job Description:

• 根据项目需求，带领1-4人的研究团队，负责或者参与溶瘤病毒以及抗体抗体类管线的早期研发工作； 
• 合理制定实验研究方案，开发新实验体系，高效合规完成药物的体内外功能评估等实验内容，收集数据和分析整理实验结果并完成研究报告，能够撰写相关文档支持临床申报； 
• 根据项目需要参与或负责与其他团队以及第三方CRO机构的沟通，跟踪相关任务进度，监督CRO研究质量和审核研究数据； 
• 负责相关的SOP建立和更新； 
• 参与实验室日常维护以及完成主管安排的其他工作。

Qualification:

• 专业要求：分子/细胞生物学，生物化学，免疫学等生物相关学科博士，3年以上工业界工作经验； 
• 至少2年以上大分子生物医药研发经验，熟悉肿瘤免疫治疗或者自免类疾病治疗药物的研究并掌握常用的实验技术，包括细胞培养，病毒包装，基因编辑，细胞死亡的检测，细胞因子检测，免疫荧光，流式检测，基因检测等。具备良好的实验习惯和数据处理分析、解决问题的能力； 
• 有肿瘤免疫治疗和抗体类药物开发项目经验优先，有参与实验室管理经验者或带团队经验优先，有参与IND申报经验者优先；
• 工作态度积极主动，反馈及时，严谨细致，责任心强，具备良好的理解表达沟通能力和团队配合精神，能够高效组织和执行项目； 
• 有良好的英文文献阅读能力，能够独立制定研究方案和撰写研究报告；
• 熟练使用Prism、Flowjo、Snapgene等专业分析软件。

Job Description:

• Responsible for Pyrotech’s Phase I-III and investigator-initiated clinical studies, can be initiated, conducted, and closed according to established timelines and plans. Identify risks and resolve issues.
• Collaborate with internal and external cross-functional stakeholders to identify and select study vendors, including but not limited to CROs, laboratories, SMOs, etc. Negotiate quotes and contracts.
• In addition to clinical operations activities, serve as the primary coordinator of a study to lead and facilitate study team to in developing and reviewing study plans—including project timelines, investigational product supply plans, essential documents, and project plans—ensuring their reasonableness and completeness.
• Manage CROs and other third-party vendors (e.g., labs, SMOs, PROs), including financial activities and their performance. 
• Oversee site management activities, including site feasibility & selection, site initiation, CRA monitoring, quality-related activities, data, documentation, and safety management, and site close-out.
• Monitor key milestones throughout the study lifecycle, proactively identify risks, and resolve issues in a timely manner to ensure studies are executed within planned scope, schedule, budget, and acceptable quality.
• Report project progress regularly or as required. Establish and maintain effective communication and collaboration with internal and external partners, key opinion leaders, and investigators throughout the study period.

Qualification:

• Bachelor’s degree or master’s degree in a medicine-related discipline
• For Senior CTM, no less than 7 years of total working experience include at least 3 years of clinical operations project management experience. For CTM no less than 5 years of total working experience include at least 1.5 years of clinical operations project management experience.
• Experience with managing global study or the clinical studies conducted oversee is a plus
• Knowledge of the relevant drug development process including project and site management, local and international regulations, ICH-GCP, drug safety requirements, data management processes, budget and vendor management and other functions or industry knowledges.
• Ability to travel extensively within country and rarely for Intercontinental trave as well.
• Excellent communication skills
• Fluent written English, fluent spoken English is a plus. Proficiency in Chinese is a plus (for abroad candidates only)
• Ability to handle high volume of work and tight deadlines
• Proficiency in MS Office, including Word, Excel, and PowerPoint.

Job Description:

• Overall responsibility for drug substance and drug product activities from preclinical development through clinical supplies for Phase 3 registration studies. 
• Identification, selection and management of Contract Development and Manufacturing Organizations (CDMOs) for process optimization, cGMP manufacture and supply of Drug Substance (API) and Drug Product (DP).
• Develop and implement strategy and design of experimentation for optimizing and controlling quality of bulk API and DP using CDMO. 
• Delivery of robust, scalable and cost-effective manufacturing routes and drug product formulations that meet or exceed the target clinical profile.
• Projection of API and DP needs for preclinical and clinical programs (with clinical team), and associated budgets (with finance team). 
• Formulation design/development in support of clinical studies.
• Management of supply chain and logistics in support of clinical studies. 
• In coordination with Quality Assurance, implement stage appropriate analytical methods and protocols and ensure that all CDMOs are using systems and processes in compliance with all relevant regulatory standards.
• Execute plans for the validation and registration of API and DP as required by cGMP, ICH (International Conference of Harmonization) and NMPA / FDA regulations. 
• Writing and reviewing documents for INDs / regulatory section submissions; represent the company as the CMC expert before China and U.S. regulatory authorities. 
• Prepare, review or edit cGMP batch records, CMC regulatory and Quality documents. 
• Prepare technical reports, publications and oral presentations. 

Qualification:

• Substantial experience in managing China and International CDMOs for the manufacture of cGMP APIs and DP.
• Substantial experience with projects in clinical development e.g. Phase 1 through Phase 3 including multiple pharmaceutical dosage forms (e.g. tablets, capsules, topicals, etc.) .
• Experienced with cGMP manufacturing and IND and NDA filings; thorough knowledge of relevant NMPA and FDA regulations. 
• At least 10 years relevant experience in a pharmaceutical or biotechnology CMC/cGMP environment. 
• Experience in supply chain management .
• PhD or MS with 10+ years of experience; Advanced degree in Organic Chemistry or related scientific discipline is preferred. 
• Able to identify and resolve critical issues. 
• Experience implementing technical, strategic and operational plans. 
• Excellent written and verbal communication skills, exceptional interpersonal and management skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators).