● 招聘公司：Certara
● 公司简介：Certara是一家行业领先的决策支持技术和咨询服务提供商，致力于优化药物开发和改善健康结果。Certara的解决方案跨越药物开发和患者护理生命周期，通过使用最先进的科学建模和仿真技术以及监管策略，帮助提高监管和商业成功的可能性。其客户包括数百家全球生物制药公司、领先学术机构和关键监管机构。● 招聘职位：药物计量学家/PKPD建模师(副主任级) ● 职位类型：全职 ● 职位薪酬：$70,000+ ● 工作内容： - 通过与其他合作伙伴、高级专家建模师和药物开发顾问的团队合作，为Certara的客户支持项目。
- 作为一名收费顾问，为客户项目提供药物计量学模型。
- 继续学习先进的建模和仿真方法，重点学习适合于复杂生物学、双特异性生物学、嵌合抗原受体t细胞治疗和免疫肿瘤治疗的方法。
- 对模型代码和报告进行质量控制。
- 可能领导/协调公司的计划(例如:IT，方法，效率，自动化，质量)。
- 可以作为客户的主要联络点，并与高级顾问合作，发展符合客户兴趣的业务。
● Responsibilities： - Support projects for Certara’s clients by working in teams with other Associates, senior expert modelers, and drug development consultants.
- Hands on pharmacometric modeling on client projects as a billable consultant.
- Continuing education on advanced modeling and simulation approaches, with an emphasis on methods appropriate for complex biologics, bispecific biologics, chimeric antigen receptor T-cell therapies, and immuno-oncology therapies.
- Conduct quality control activities on model codes and reports.
- May lead/coordinate company initiatives (e.g. IT, methodology, efficiency, automation, quality).
- May act as the primary point of contact for clients and collaborate with a senior consultant to grow business to match their interests.
● 职位要求： - 生物工程、药学、药理学、统计学、应用数学或相关专业博士、医学博士、药学博士。
- 有在研发、临床前和临床环境中工作的3 - 5年行业经验。
- 具有扎实的药物计量学、临床药理学、药物动力学或项目团队相关学科经验者优先。
- 具有很强的定量技能的PK/PD建模方面的专业知识，并为满足特定的药物开发问题而量身定制。
- 熟练掌握PK/PD及统计软件(如Phoenix WinNonlin)和编程语言。
- 精通建模(如popPK和PK/PD分析)。
- 有在临床试验过程中移动化合物的经验，有临床开发、试验设计和管理的各种要素的经验者优先。
- 通过与客户的互动来发现新的业务发展机会的开发能力。
- 良好的英语听说读写能力。Certara是一家全球性的公司，额外的语言是有益的。
● Requirements： - PhD, MD, PharmD in Bioengineering, Pharmaceutical Sciences, Pharmacology, Statistics, Applied Mathematics, or related field.
- 3 to 5 years of industry/consulting experience (may be combined with academic research) working in R&D, pre-clinical and clinical environments.
- Solid experience in pharmacometrics, clinical pharmacology, pharmacokinetics, or a related discipline in a project team setting is preferred, whether in academia or industry.
- Expertise in PK/PD modelling with strong quantitative skills applied to develop models with nonlinear behavior, mechanistic or semi-mechanistic components relating to mechanism of action and tailored to meet specific drug-development questions.
- Proficiency in PK/PD and statistical software (e.g., Phoenix WinNonlin, Phoenix NLME, Trial Simulator, NONMEM) and programming language(s) (e.g., R, SAS, S-Plus).
- Proficient in modeling (e.g., popPK and PK/PD analyses, model-based meta-analysis, dose-response and exposure-response analyses, dataset creation, database augmentation, disease modeling, trial simulation, optimal study designs, strategic decision analyses, economic modeling).
- Experience in moving compounds through the clinical trials process and experience with various elements of clinical development and trial design and management and filings preferred.
- Independent performance of analysis and modeling and development of reports with limited supervision.
- Comfortable in a client environment able to communicate with and collaborate with peer scientists.
- Developing ability to identify new business development opportunities through client interactions.
- Proficient in spoken and written English. Certara is a global company, and additional languages are of benefit.
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