上海招聘

Responsibility

• Work independently or collaboratively with experienced team member in clinical pharmacology supporting ongoing projects.
• Perform or assist with PK/PD analyses including modeling and simulation for understanding of the PK/PD relationship of drug candidates.
• Review and QC analysis results and outputs for other team members.
• Ensure working process following good practice of study requirement and SOPs.
• Participate in ongoing group meetings and project team meetings including data analysis, slide preparation for study updates and identified issues.
• Be exposed to various other functions within the clinical pharmacology.

Professional Experience and Education Requirements

• Master degree in pharmacokinetics, pharmaceutical sciences, or related discipline; Ph.D. or Pharm.D. will be a plus
• For Senior Specialist / Specialist positions, generally 2 or more years hands-on experience in PK / PD analysis, or clinical pharmacology or related experience
• Understanding of China, US, European, or other countries / regions regulatory requirements and guidelines
• Solid knowledge of pharmacokinetic principle and drug development process
• Must be proficient with at least one PK analysis software such as Phoenix WinNonlin, NONMEM etc.
• Ability to interpret analysis results and impact on the study medication
• Candidates must be detail-oriented, highly organized and able to manage multiple tasks.
• Candidates must have the ability to work individually (independently) as well as on a team
• Strong motivation and problem-solving abilities are required
• Knowledge in relevant Therapeutic Areas to enhance contributions to a project
• Familiar with ICH/GCP guidelines, and FDA, EMA, and CFDA guidance
• Proficient in spoken and written English

备注： ‘职位月薪’ 仅供参考，具体薪资和福利将根据候选人经验和能力综合评定。

全球知名生物医药企业资深研发团队打造的创新服务公司。让你的职场起点更高，更充满挑战和精彩。
 
我们是谁？
 
    基于中国面向全球制药，生物技术和医疗器械公司的临床开发服务和解决方案提供商:
· 临床试验全程及专业领域服务：临床试验设计、数据管理及系统开发、生物统计及编程、运营和项目管理、报告撰写、注册运作和策略、质量保证和稽查、药物安全警戒和风险管理
· 战略咨询服务：临床开发和注册策略、研发功能和架构设计、技术支持和国际化支持。
 
为什么选择我们？
 
· 缔脉定位于以高品质服务和专业精神成为业界典范。
· 缔脉管理层在中国生物医药研发领域耕耘十多年培养了1000+优秀人才。
· 缔脉致力于通过系统培训，研发实践和开放式文化培养新一代生物药物研发国际化人才。
 
创始人及部分核心专业领域


创始人 - 谭凌实博士：拥有20多年跨国一流制药公司总部高级管理经验。此前担任辉瑞公司全球药物开发运营副总裁，在中国成功创建了首屈一指的研发中心，且经历10多年发展壮大到多个地点，成为辉瑞全球核心的研发中心之一，承担药物临床开发、安全风险管理、注册、临床稽查等关键职能。谭博士多年为RDPAD, DIA 的核心成员，担任重要职务,包括研发委员会主席, 全球董事等。谭博士还带头建立了与国内一流高校的教育培训合作，比如复旦大学、北京大学，交通大学。培养了不少拥有专业技能和行业知识的临床数据管理和编程人才。谭博士有在美国建立初创企业的经验，且在美国一流制药企业研发中心工作多年。谭博士拥有生物统计博士学位。