深圳招聘

The department of Clinical Pharmacology and Pharmacometrics (CPPM) at 3D Medicines is seeking dedicated clinical pharmacologists with strong modeling & simulation skills to support oncology programs that are in early to late stages of clinical development. The individual selected for this position will have the opportunity to work on both small molecules and biologics in the oncology area and is expected to represent the CPPM department independently on clinical study teams on assigned studies.

The qualified candidate will be responsible for executing clinical pharmacology deliverables in collaboration with internal and external partners in an efficient and scientifically rigorous manner. The candidate will be responsible for all aspects of PKPD analysis, quantitative modelling & simulation strategies, interpretation and reporting of clinical pharmacology related studies including but not limited to first-in-human, drug interaction, biopharmaceutics and mass balance studies for candidate drug products from early development (pre-IND) through late stage development to improve the efficiency of drug development, improve our mechanistic understanding and support dose selection.

The qualified candidate is expected to establish and develop strong relationships with key cross functional partner functions such as clinical operations, clinical development, biostatistics, data management, medical writing, regulatory, safety and technical operations and therefore must possess excellent communication and interpersonal skills.

Key Responsibilities
-Provides clinical pharmacology support on multi-disciplinary study teams for pre-clinical and clinical programs
-Contributes expert clinical pharmacology input into key pre-clinical, clinical and regulatory documents including study protocols, study reports, investigator brochures, and other documents within agreed timelines
-Develops PK/PD modelling and simulation plans to guide rational first in human dose projection and dose selection
-Leads clinical pharmacology efforts (e.g., study design, protocol concepts/protocols preparation, clinical phase oversight, data analysis, and reporting) within assigned programs to yield high value PK/PD insight for critical decisions. Analyzes results, interprets, and recommends action based on study results.
-Accountable for ensuring appropriate design and implementation of a clinical modelling and simulation plan and interpreting results.
-Performs or oversees PK / PD analyses, population PK and exposure-response analyses using a variety of tools and approaches. Integrates, interprets and reports data to project teams and other customers.
-Contributing to clinical pharmacology related clinical trial designs, authoring clinical study protocols, executing and coordinating clinical trial conduct, and finalizing clinical study reports
职位要求：
-A PharmD or PhD in Clinical Pharmacology, Pharmacology, Pharmacokinetics, or related discipline with at least 1-2 years of experience in conducting clinical pharmacology studies including study design, PKPD data analysis and/or population PK analysis, and result interpretation is required
-A working knowledge and previous experience, either in the industry or as part of the educational training, with pharmacokinetic/pharmacodynamics, drug metabolism, drug-drug interactions, and population PKPD modeling is also acceptable.
-Demonstrated ability and experience in apply modeling and simulation approaches to enable rational and efficient preclinical and clinical drug development are required
-Proficiency of the application of a broad range of quantitative tools including but not limited to WinNonLin, Phoenix, NONMEM, R and other PK/PD analysis software.
-Must excel at working in a highly collaborative matrix team environment, have good organizational, communication [both oral and written], and interpersonal skills.

思路迪（3DMed）2010年成立于上海，是最早在中国展开肿瘤精准医疗检测服务的公司之一，经过长期的耕耘发展，从集团公司分拆之后的思路迪诊断，已经是中国肿瘤精准诊断领域领军企业之一，目前在中国、美国和新加坡拥有超过800名员工。
目前，思路迪诊断已经构建了集成设备工程、电气、生命科学技术、材料学和数据分析为一体的综合性研发平台，具备实现精准诊断领域研发制造全自动化操作系统的能力。其拥有自主研发的封闭式全自动化NGS文库制备平台，以及前瞻创新的肿瘤早期诊断标志物（外泌体）开发平台，促成了基于这些平台的多个突破性辅助诊断和伴随诊断产品正在临床试验阶段或即将进入临床试验；公司传染病平台开发基于自动化和POCT化的产品服务，覆盖全球传染病诊疗网络。公司还拥有第三方医学检验所，其拥有行业权威的CAP/CLIA资质，所覆盖的精准诊断营销网络超过70%的核心三甲医院，服务对象超过800家医院，提供从肿瘤早期诊断到靶向治疗、免疫治疗、再到术后动态监测的精准医疗全程管理产品和服务。