Pharmacometrician 15000-40000元
欧洲 - 黑山
1-3年
硕士
招 1人
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安渡生物医药(杭州)有限公司
欧洲黑山 /其他行业 /民营企业 /200-500人 / 1050万
Pharmacometrician 15000-40000元
欧洲 - 黑山
1-3年
硕士
招 1人
2025-12-13 更新
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职位描述
  • 到岗时间:随时

职责描述:  Contribute to or conduct PK/PD data analysis and population modeling and simulation using industry standard software tools, including model building and refinement  Contribute to or conduct Model based Drug Development exercises for clients  Assist with the design, analysis, and interpretation of studies involving sparse sampling and provide guidance to optimize PK sampling and dosing strategies  Contribute to or conduct non-compartmental and compartmental pharmacokinetic analysis with rich sampling data as needed  Assist with providing strategic advice to clients and developing clinical pharmacology strategic plans and clinical protocol development  Work with other consultants to prepare and review pharmacometric reports and other clinical pharmacology documents.  Assist with development and validation of programming language in R for PK/PD data analyses  Author clinical protocols and clinical pharmacology and pharmacokinetic sections of regulatory documents, including INDs, NDAs, briefing packets, Investigator Brochures, etc.  Support client’s nonclinical efforts to ensure that sufficient preclinical PK data exists to design and support clinical studies and model development  Maintain current knowledge of advancements in modeling, simulation, PK, and PK/PD science, regulatory guidance documents, FDA rulings, internal SOPs, and internal working practices to be able to contribute ideas to improve technologies and procedures for PK practices  Undertake diverse scaling approaches to design optimal dosing regimens for pediatric population.  Conduct biopharmaceutics data analyses (e.g. dissolution performance) with the objective to translate in vitro formulation performance to in vivo formulation performance in humans. 任职要求:  Degree in pharmaceutical science, physics, statistics, chemical engineering or related field. Experience in modeling/simulation strategies is highly desired.  Must have proven experience in quantitative pharmacology and strong hands-on modeling and simulation experience  Experience with population PKPD modeling software (NONMEM, R, SAS, MATLAB, Phoenix, GastroPlus, etc.)  Demonstrated ability to independently plan, organize, and analyze PK/PD data is essential.  Highly motivated individual with a strong intellectual and technical background in Pharmacometrics discipline  Excellent problem-solving, written and oral communication skills.

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公司介绍
Amador Bioscience strives to provide global-standard laboratory, clinical research, strategy consulting and regulatory filing services to biopharmaceutical companies. The laboratory services focus On PK/PD/ADA assay development and sample analysis. Amador clinical research unit specializes in innovative clinical development strategy and protocol design, and initiation and monitoring of clinical studies in China and US. In addition to R&D strategy and regulatory pathway, our consulting services perform global-standard data analysis and generate submission-ready study reports. We have successfully supported CTD filings in China and US. With profound academic background and rich experience in R&D services in the biopharmaceutical industry, AmadorBio is a global clinical research team of pharmacologists, statisticians, bioanalytical scientists, translational & clinical scientists, medical scientists, clinical trial management experts, data management experts, quality assurance auditors, clinical trial managers and regulatory specialists. (40% of PhD, MD and PharmD, 35% of MS). AmadorBio provides professional services for more than 20 leading biopharmaceutical companies from early research and development, clinical development to regulatory submission in China and US. AmadorBio operates in biotech hubs: San Francisco Bay Area, USA and Shanghai-Hangzhou-Suzhou region, China, providing comprehensive solutions complied with global standards and government drug inspection regulations in China and US. The mission of Amador is to provide global-standard services facilitating the development of novel biotherapeutics. 安渡生物致力于为生物医药公司提供全球标准的实验室、临床研究、策略咨询和监管申报服务。实验室服务专注于PK/PD/ADA方法学开发验证和样本分析。安渡生物的临床研究中心专注于为美国和中国的生物医药公司提供创新的临床研究开发策略、方案设计、启动和监查的专业服务。我们的咨询服务除研发策略和监管服务外,还可提供全球标准的数据分析并生成完备的申请报告。我们在中国和美国成功地支持了多家医药公司的CTD申请。 安渡生物在美国旧金山湾区和中国长三角地区设有办公室和实验室,提供涵盖中美及符合国际标准和政府药检规范的全方位解决方案。
工商信息
  • 公司名称 安渡生物医药(杭州)有限公司
  • 法定代表人 -
  • 成立日期 -
  • 企业类型 -
  • 经营状态 -
  • 注册资金 1050万人民币
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