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.