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岗位职责：

• 负责GLP体系范围内的各平台、仪器设备的网络正常运行，监督网络通信状况，网络安全，监控整个局域网的运转和网络通信流量；
• 为实验室以及办公室计算机电子数据备份系统NAS提供必要的技术支持；
• 负责公司常用软件的安装、运维或提供必要的技术支持；
• 监控、系统、服务器的运行、调试、维护、异常问题处理；
• 维护IT现有的设备和服务。含桌面设备、服务器、网络、应用系统、备份系统、门禁系统、监控系统等；
• 为公司的IT网络的建立提供建议；
• 以上工作如可远程操作，可远程操作。必要情况下，需要实地提供技术支持。

岗位要求：

• 全日制本科及以上学历，计算机及相关专业，大学英语四级及以上；
• 二至三年以上专业工作经验，熟悉交换机，防火墙；
• 熟悉网络、监控、机房系统，对仪器组网维护有一定了解；
• 熟悉GLP/GMP质量管理体系优先考虑。

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Purpose

Amador Bioscience Inc. (“AmadorBio”) is a Contract Research Organization company providing high-quality integrated services in R&D consulting, bioanalysis, clinical trial management and regulatory submissions. AmadorBio strives for both high-quality results and a superior customer experience. Our clients include global pharmaceutical and leading biotech companies. AmadorBio operates in the San Francisco bay area and Shanghai-Hangzhou, biotech hubs in the US and China.

To meet the needs of business growth, we are looking for several Pharmacokinetic Associate Scientists or Scientist to join our passionate team. The primary function of a PK Associate Scientist / Scientist is to support clinical pharmacology consulting project leaders through all stages of new drug development cycle. He/she will be responsible for all aspects of PK-related support, including data evaluation, interpretation, reporting, and generation of manuscripts/abstracts for publication.

 Role and Responsibilities

• Support PKPD project leaders by performing PK data evaluation, analysis, interpretation, reporting of nonclinical and clinical studies
• Perform noncompartmental data analysis; Comply with GLP regulations for GLP toxicokinetic studies
• Prepare nonclinical PK/TK reports, clinical PK sub-reports, study protocols and data analysis plans
• Conduct population PK and PK-PD modeling and simulations in collaboration with PKPD project leaders
• Aid PKPD project leaders in the preparation of clinical pharmacology components of regulatory submission documents (e.g. IND, EOP2, BLA/NDA, IB)
• Collaborate with PKPD project leaders and scientific writer to generate abstracts and manuscripts for external presentation and publication
• Work in team environment, involve in process improvement and SOP development if needed.
• Participate in meetings with clients or assist hosting client visits.
• Other assigned responsibilities that are related to AmadorBio’s business.

Qualifications and Education Requirements

Education:

• BS or MS degree in pharmaceutical sciences, biological sciences, Statistics, Mathematics, Chemistry or other relevant scientific fields.

Experience:

• Previous job experience in drug development is preferred. Knowledge in GLP regulation is a plus. Prior training in pharmacokinetic data analysis is desired but not required.

Special Skills/Abilities:

• Strong analytical and technical writing skills are required for this position.
• Good communication and organization skills are essential.
• Prior experience with PK data analysis and reporting is highly desirable.
• Familiar with GLP practices is desirable. 
• Good written and verbal communication skills are required.

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岗位职责

• 设计和开发药动/药效、免疫原性和生物标志物的免疫分析方法学或细胞分析方法学。
• 按照验证计划、内部SOP和分析规程，完成生物分析/生物标志物方法学验证，并测试临床前/临床研究的生物样品。
• 按照GLP/GCLP规范做好实验记录和归档。及时记录偏差并报告给项目负责人。
• 与项目相关的客户沟通，审查和评估数据，参与撰写分析规程和研究报告。
• 评估项目进展情况，及时向项目负责人汇报并协助解决问题。
• 其他与公司业务相关的职责。

任职要求

• 生物学、免疫学、生物化学、药理学或相关科学领域专业的学士或硕士学位。
• 1-2年以上相关工作经验。有GLP/GCLP实验室工作经验者优先。
• 愿意学习新技术，能同时执行多项任务。
• 有责任心，工作认真踏实，愿意与团队合作，遵守公司规章制度。
• 熟练使用MS Office和其他相关的计算机软件。

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ROLE AND RESPONSIBILITIES

• To establish pharmacokinetics consulting function in China; Lead or contribute to business development strategy, client interactions, talent recruitment and publication/promotion.
• Performing noncompartmental analysis for nonclinical and clinical studies; authoring and /or reviewing relevant documents including protocols, analysis plans, reports and regulatory documents; in collaboration with other functional groups contributing to regulatory submission packages. 
• Providing strategic advice to clients and developing product development strategic plans.
• To ensure PK deliverables meet agreed timelines and budget, and all related operations and procedures in compliance with protocol, Amador’s SOPs, ICH-GxP and applicable local regulations.
• Contributing to functional excellence in science, including quantitative pharmacology, population modeling and simulation, and regulatory science.
• Providing input and direction on development of client network and promoting service excellence and expansion to clients. 
• Leading, developing and implementing operational initiatives that enable Amador to compete more vigorously in a constantly changing and demanding marketplace.

QUALIFICATIONS AND EDUCATION REQUIREMENTS

Education:
• A master or doctorate degree in pharmaceutical sciences, medicine,  engineering, chemistry or other relevant scientific fields.

Experience:
• PhD with 2+ years or MS with 6+ years of relevant experience in biopharmaceutical development or regulation 

Special Skills/Abilities:
• Prior experience with PK data analysis and reporting is required.
• Strong analytical and technical writing skills are required for this position. 
• Good communication, managerial and organization skills are essential. 
• Demonstrated capability to lead teams is desired

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岗位职责

• 协助管理实验室和办公室的日常运转工作。
• 实验室样品管理（样品接收和入库及领用台账整理及复核等）。
• 实验室耗材及试剂和办公室用品等的申购和库存管理。
• 根据规定协助实验室安全管理工作。
• 实验相关材料数据的整理及复核。
• 协助实验室完成实验相关任务。

任职要求

• 有生物学等相关专业专科或以上学历，有一年以上相关实验室管理员工作经验。
• 善于沟通、工作认真严谨细心、为人踏实、有良好的团队精神。
• 有实验室管理和科研经验者优先考虑。

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Main Accountabilities:

• Assist BD director to find business opportunities and cultivate client base，contribute to revenue increasing.
• Present and promote services and solutions to potential clients，effectively communicate features & benefits & capabilities of Amador Bioscience with clients, develop new business and marketing opportunities with the objective of establishing long term, mutually beneficial business partnerships.
• Assist BD Director to generate，lead and close business for laboratory services，clinical research and consulting & regulatory units.
• Promote academic cooperation and exchanges with domestic and foreign pharmaceutical companies，responsible for preparation, organization and coordination for holding/participating in various external and internal meetings/ exhibitions.
• Collect and disseminate accurate and complete information from clients to internal technical staff to understand the scope of work.
• Work with operational staff to define project scope and combine with existing capabilities to generate the scope of work and provide timely price quotations/proposals.
• Write and develop proposals and contract templates.
• Assists in reviewing, writing and negotiating contract terms and conditions.
• Follows up on quotations for purposes of both gathering client feedback and expediting client decisions.
• Complete paper work (i.e., sales/call reports, quote requests, and expense reports) and updates Client Relationship Management (CRM) tool in a timely manner.
• Familiar with the domestic and international CRO research and development trends and global pharmaceutical market，and provide advice on the company's development direction and strategy development.

Role Related Qualifications/ Skills:

• Bachelor’s degree or above, major in biology, medicine, pharmacy, etc. is preferred;
• 2-3 years of working experience in business development in biotech/biopharma industry, and a profound accumulation of clients in the pharmaceutical industry;
• 2 years BD experience with direct interaction with mid-level and executive level decision makers in the pharmaceutical and biotech companies;
• Excellent at communication and negotiation, with good teamwork spirit;
• Familiar with domestic and foreign pharmaceutical companies, market status and development trends, strong market sensitivity, information capture capabilities and pioneering spirit;
• Good adaptability and can work under time constraints and task pressures;
• Honest and trustworthy, with a good sense of corporate image.

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Main Accountabilities:

• Be responsible for researching and mining talent using job platforms in China & US and other sourcing tools and make candidate recommendations
• Be a brand ambassador and able to articulate the company vision values and culture while simultaneously being an expert in assessing skills fit and experience to recommend candidates for current or prospective openings
• Work closely with each Business Unit to support a variety of roles
• Conduct and organize interview and recruiting procedure
• Develop candidate pools that can quickly backfill openings within each function team
• Search for candidates with specialized skill sets in pharmaceutical industry
• Conduct an initial phone screen to determine experience, level, interest and provide detailed information and candidate’s feedbacks 
• Assist in conducting market mapping in key functional areas
• Reach out to passive and active candidates using variety of sourcing strategies 
• Explore developing relationships with universities and building awareness of Amador through business publications and other channels. 
• Other tasks assigned by the hiring manager

Role Related Qualifications/ Skills:

• Bachelor’s Degree or above
• Equivalent 3 years of recruiting or sourcing experience in search firm or in-house recruiting team in pharmaceutical industry
• Outstanding communication and influencing skills 
• Persuasive persistent and patient 
• Professional demeanor and polished interpersonal skills able to easily establish rapport with people 
• Quick learner 
• Able to work well independently and as a team player 
• Good judge of character 
• Experience hiring sourcing in pharmaceutical industries 
• Familiar with candidate sourcing features on Linked-in and other key platforms 
• have a good awareness of and focus on creating a positive candidate experience

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Main Accountabilities

• Plan, conduct and report GCP audits at clinical trial sites , for both Chinese trials and global trials. 
• Lead the preparation work and host regulatory inspections related to the Amador clinical trial
• Ensure implementation of a QA system in accordance with the guidance documents within the clinical area; 
• Set up the local documents system according to the local requirements and ensure the implementation  
• Review the process/SOPs and prepare the solution if any bias from regulation / global requirements;
• Provide comments / suggestions to the daily operation works;
• Participates in client and regulatory inspections/audits, might represent the department, and participates in developing and tracking corrective actions.
• Provides training for department and/or laboratory staff where required.
• Verifies accuracy of analytical results and sample identification; inventories and submits data to archives. Provides support for quality investigations and contracted services.
• Participates in risk assessments.

Role related Qualifications/ Skills:

• University degree in medicine, pharmacy or other life sciences 
• At least 8 years in clinical operations and 1 year in Quality Control or Quality Assurance.   
• Good understanding of Phase 1-3 clinical trials quality control principles, clinical monitoring procedures, all relevant GCP guidelines and of local and international regulations.
• Good team player, self -motivated  and attention to details.
• Competent in written and oral English.

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Main Accountabilities:

•    To ensure all related clinical research operations and procedures are in compliance with protocol, Amador’s SOPs, ICH-GCP and applicable local regulations.
•    To be able to contributre to the study site selection process by preparing feasibility questionary and perform the initial site contacts through phone calls and site interviews. 
•    To be responsible for clinical study sites selection and to ensure these sites can meet the Reistone’s requirements and qualified with FDA. 
•    To be responsible for clinical trail start-up at sites, include complete GCP submission, obtain the EC approval, contract negociation and sign-off.
•    To be responsible for initiating, monitoring and closing the clinical study sites and submit the visit reports on time. 
•    To be responsible for submitting documents to site GCP office & EC correctly and on time.
•    To ensure storage, distribution, return IMP/NIMP at the sites and report of deviations in compliance with protocol, Reistone’s SOPs, ICH-GCP and applicable local regulations.
•    To be responsible for using CTMS or required system and trackers in clinical trial and ensure information entered into CTMS or required system and trackers is accurate and updated regularly
•    To ensure AEs/SAEs are recorded correctly and reported approprately according to timeline stipulated in clinical study protocols and current regulation.
•    To ensure the study sites update and maintain essential documents in Investigator Site Files correctly and on time.
•    To be responsible for transfer Amadorstudy essential documents to TMF on time and consist with ISF.
•    To build and keep good working relationship with clinical study sites.
•    To be able to complete the above tasks independently with satisfaction, and coach the junior team members in their training and daily activities.
•    To conduct co-monitoring visits and perform internal quality control to the assigned studies. 
•    To develop various study specific forms/templates and prepare/manage study status reports
•    To contribute to the review of all SAEs, ensure medical monitor sign-off, site notification and compliance with all company precedures.
•    To contribute to the database lock by participating in data listing review.
•    To be able to develop and maintain basic working process of relevant studies and assist in the coordination of the assigned study/project and perform other team duties as required or delegated by the CPM.

Role Related Qualifications/ Skills:

•    3-4 years of CRA experience in a CRO or pharmaceutical & medical device compamy.
•    Bachelor’s degree or above in Medical, Pharmacy or related areas.
•    Comprehensive knowledge and understanding of ICH-GCP and applicable local regulations.
•    Excellent in communication skills and is expected to establish good relationship with the Investigators and other related site staffs. 
•    Fine written, verbal skills, and presentation skills

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Role and Responsibilities

•    This individual will be responsible for aligning/merging data sets, apply binding codes, and preparing merged data sets for pharmacokinetic/pharmacodynamic analysis and modeling. 
•    Generating tables and listings accounting for the disposition of patients and samples, descriptive statistics of pharmacokinetic variables, and results. 
•    Creating figures to include but not limited to: drug concentration over time, pharmacokinetic parameters over dose, concentration-effect relationship, and efficacy/safety analyses. 
•    Contributing to the clinical study reports and regulatory submissions
•    Collaborating with project leaders and statisticians on study protocol design and lab data evaluation (eg ADA cutpoint)

Role Related Qualifications/ Skills:

Education:

•    BS or MS degree in pharmaceutical sciences, biological sciences, Statistics, Mathematics, Chemistry or other relevant scientific fields.
Experience:

•    Basic understanding of biostatistics 
•    Experienced in data analysis

•    Able to take directives and work independently 
•    Excellent problem solving skills 
•    Excellent interpersonal skills 
•    Proficient in SAS programming. 
•    Basic to advanced understanding of "R" 
•    Proficient in Excel and Excel macro generation.
•    Basic understanding of pharmacokinetic principals and some exposure to WinNonLin and/or NONMEM is a plus 
•    MS in Statistics, mathematics, engineering or relevant fields

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Main Accountabilities:

•    Responsible for ensuring the completeness quality and integrity of the subject data in the clinical trial database 
•    Responsible for data management activities within a clinical trial according to regulations applicable Standard Operating Procedures (SOPs) and Processes 
•    understanding key processes and principles associated with role including CRF design, database set-up, edit check specification, DMP and data cleaning activities.
•    Review protocols to ensure the data collection, database and reporting requirements can be met and are standardized across the program
•    Accountable for the implementation of data activities including Study Startup, Data Acquisition, Standards and Discrepancy Management for the responsible studies. 
•    Reconcile the patient database with the Serious Adverse Event database 
•    Document all efforts of data management and file all responsible documents
•    Works independently receives instruction primarily on unusual situations
•    Ability to organize multitasks prioritize and deliver on time
•    Ability to communicate effectively and appropriately with internal external stakeholders 

Role Related Qualifications/ Skills:

•    Bachelor’s degree or equivalent in a natural/medical science data management or related discipline
•    Demonstrated basic knowledge of data management processes and principles in area of responsibility
•    Demonstrated basic knowledge of Windows Environment and its applications (Word Excel PowerPoint Project etc.) 
•    Good learning capability self-motivated on adopting learning into practice under supervision towards working independently on routine responsibilities 
•    3-5years of data management experiences
•    Demonstrated good English comprehension skills both reading and writing

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Main Responsibilities:

•    Design, create and test clinical database to ensure data collection tools and databases align with the protocol and adhere to GCP, SOPs, corporate standards and regulatory
•    Performs database set up according to annotation CRF (aCRF) and Database Structure Specification.
•    Updates database following the database User Acceptance Test (UAT)
•    Develops the System and SAS Edit Checks according to Data Validation Plan (DVP)
•    Updates System EC following the EC UAT results
•    Develops data management report in Clinical Database System.
•    Develops SAS programs to produce data listings and reports for data reviews.
•    Understands and complies with core data management operating procedures and working instructions.
•    Develops and maintains good communication and working relationships with CDM team.
•    Performs other activities as required  

Role Related Qualifications/ Skills:

•    Bachelor’s degree in computer science/statistics or related field
•    Skills in database design, database structure and programming languages
•    Hands on SAS skills in Base SAS, Report.
•    3-5 years of database development and programming. At least 2 to 4 years’ experience with Medidata RAVE database
•    Proficient verbal and written communication skills, both in Chinese and in English
•    Experiences in health care, pharmaceutical or CRO industry
•    Leadership, verbal and written communication

请将您的求职信和简历发送至 [email protected]

Main Accountabilities:

•    Responsible for the business development activities to find business opportunities and cultivate client base，contribute to revenue increasing
•    Generate，lead and close business for laboratory，clinical research and consulting & regulatory units
•    Set up business development strategic plan，execute，follow-up and control accordingly
•    Develop potential clients，effectively communicate features & benefits & capabilities of Amador Bioscience with clients，and maintain stable relationships with them
•    Promote academic cooperation and exchanges with domestic and foreign pharmaceutical companies，responsible for preparation, organization and coordination for holding/participating in various external and internal meetings/ exhibitions
•    Collect and disseminate accurate and complete information from clients to internal technical staff to understand the scope of work
•    Work with operational staff to define project scope and combine with existing capabilities to generate the scope of work and provide timely price quotations/proposals
•    Write and develop proposals and contract templates.
•    Assists in reviewing, writing and negotiating contract terms and conditions
•    Follows up on quotations for purposes of both gathering client feedback and expediting client decisions.
•    Complete paper work (i.e., sales/call reports, quote requests, and expense reports) and updates Client Relationship Management (CRM) tool in a timely manner.
•    Familiar with the domestic and international CRO research and development trends and global pharmaceutical market，and provide advice on the company's development direction and strategy development

Role Related Qualifications/ Skills:

•    Bachelor’s degree or above, major in biology, medicine, pharmacy, etc. is preferred; 
•    3-5 years of working experience in business development in biotech/biopharma industry, and a profound accumulation of clients in the pharmaceutical industry; 
•    Excellent at communication and negotiation, with good teamwork spirit; 
•    Familiar with domestic and foreign pharmaceutical companies, market status and development trends, strong market sensitivity, information capture capabilities and pioneering spirit; 
•    Good adaptability and can work under time constraints and task pressures; 
•    Honest and trustworthy, with a good sense of corporate image.