迪哲（上海）医药有限公司招聘2024秋季校园

迪哲医药 2024秋季校园招聘

迪哲（上海）医药有限公司 发布于2023-09-27

迪哲医药   

迪哲医药（股票代码：688192）是一家处于临床开发阶段的全球创新型生物医药企业，专注于恶性肿瘤和免疫性疾病领域，致力于开发具备差异化竞争优势的全球创新药。基于行业领先的转化科学和新药分子设计与筛选技术平台，公司已建立了具备全球竞争力的在研管线，其中两大领先产品已处于全球关键性临床试验阶段。
公司网址：

 

                             

投递方式：staffing.hr@dizalpharma.com

联系电话：021-61097800

 

校园招聘招聘简章:

职位：Clinical Pharmacologist 临床药理助理研究员

部门：Clinical Development 临床开发部

专业：Clinical Pharmacology, Medical Related 临床药理及医学相关专业

学历：Ph.D 博士研究生

地点：Shanghai 上海

人数：1人

Responsibility:

- Good understanding of the drug development process with experience managing data, writing clinical pharmacology/pharmacokinetic reports and regulatory submissions, and be responsible for PK section for clinical protocols

- Conducts clinical pharmacology studies in line with product development strategies, insure working process following regulatory requirement and scientifically sensible

- Assists with managing timelines and budgets to ensure efficient execution of clinical pharmacology studies and early phase trials

- Perform and assist PKPD analysis for understanding of PKPD relationship for drug effect and dose selection to ensure development of safe & effective dosing regimens for various patient sub-populations & also ensure optimal drug development

- Participate in project meeting, and actively involved in data analysis, study preparation for the update and issue solving

Requirement:
1. Master or Ph.D in pharmacokinetics, pharmaceutical sciences, or related discipline or Master with strong background, who has extensive experience in the pharmaceutical/biotech industry in clinical pharmacokinetics or a related discipline
2. Solid knowledge of clinical pharmacokinetic concepts and extensive working experience of clinical pharmacology programs and analysis software along with PK modeling
3. Excellent written and oral communication, interpersonal and problem solving skills
4. Understanding of China, US, European, or other countries / regions regulatory requirements and guidelines
5. Hands-on experience in physiologically-based PK modeling and population PK analysis, or detailed knowledge of PK software (e.g. WinNonlin, Simcyp, NLME, NONMEM, etc.) is plus

 

 

职位：Medical Scientist 临床研究助理医师

部门：Clinical Development 临床开发部

专业：Medical Related 临床医学专业

学历：Ph.D 博士研究生

地点：Shanghai 上海

人数：1人

Responsibility:

- Work closely with physician for clinical development plan (including protocols) for Dizal projects

- Support physician to conduct successful clinical studies with all in-scope integrity (i.e., providing medical monitoring)

- Provide science review and analysis to support physician shaping clinical study design and product strategy 

- Co-owners of clinical study delivery 

- Work closely with physician for development documents (CIB, protocol and CSR, etc.) 

- Work closely with physician to analyse and interpret clinical study results in partnership with other development functions

- Work closely with physician to form and run advisory board meeting; Be responsible for interacting and communicating with KOLs for development strategy and protocol design 

- Support regulatory filing and registration 

- Provide consultation to clinical operation colleagues on protocol design questions and answer protocol related questions from site investigators

Requirement:
？ General disease Knowledge

？ General compound knowledge 

？ General Regulatory knowledge

？ Investigator & site knowledge

？ Medical monitoring

？ Safety monitoring and evaluation of signals

？ CSP/CSR content & data analysis

？ Presentation & communication skill

？ Clinical trial landscape and competitive intelligences

 

 

 

职位：Statistical Programmer统计编程师

部门：Clinical Development 临床开发部

专业：Statistics Related 统计相关专业

学历：Master 硕士研究生

地点：Shanghai/Beijing 上海/北京

人数：1人

Responsibility:

· Work with Clinical Physician, Biostatistician and external vendors when applicable to support the programming activities in clinical trials for Dizal products

· Develop and/or implement SAS programs to produce SDTM, analysis datasets, Tables, Listings and Graphs in clinical trials for Dizal products

· Lead or assist in statistical programming deliverables for one or more clinical studies

· Assist in the review of key study-related documents produced by other functions, e.g. SAP, case report form, data management plan, database specifications, EDC data structures, DMC plans and other clinical documents

· Follow CDSIC Implementation Guide to review and confirm dataset specifications and eCRF annotations for creation of SDTM datasets

· Follow CDSIC Implementation Guide to review and confirm dataset specifications for creation of ADaM datasets

· Develop programs to produce SDTM, ADaM, tables, listings and graphs according to specifications

· Implement QC validation in accordance with internal SOPs and WIs, and industry regulatory requirements

· Contribute to the study programming activities. Manage and maintain programs, programming documents and deliverables

· Provide timely, accurate, and adequate responses and inputs for internal and external inquiries or ad-hoc analyses

 

Requirement:

· M.S. in Statistics

· Working knowledge of statistical and data processing software, e.g., SAS and/or R

· Experience with pharmaceutical industry data standards, such as CDISC/SDTM and ADaM data models

· Knowledge of statistical concepts, such as p-values, rates and proportions, frequencies, confidence intervals, especially survival analysis. Capable of implementing these ideas in clear, efficient SAS code for the purpose of data analysis and reporting

· Good verbal and written communication skills

· Good attention to detail to ensure accuracy and reliability of results; builds and monitors quality in every work activity

· Proactive and motivated. Ability to learn

 

 

 

职位：Data Management Trainee 临床数据管理培训生

部门：Clinical Operations 临床运营部

专业：Pharmacy & Medical Related 药学，医学相关专业

学历：Master 硕士研究生

地点：Shanghai 上海

人数：2人

Responsibility:

- Be responsible to execute activities in Study set up, including but not limited to

· Review the key study documents, e.g. study protocol, Rave build specification, Edit check specification, Data Management plan, etc.

· Perform the User Acceptance Testing (UAT)

· Work with LDM in the process of Manual data review specification and External Data Transfer specification, etc.

- Be responsible to perform the data validation activities throughout the study life cycle, including but not limited to 

· Query management

· Manual data review

· SAE reconciliation

· External data reconciliation

- Master the data management filing requirement and be responsible to upload the DM documents into eTMF system on timely manner with good quality.

- Support LDM on the activities to

· Collaborate with CRA to analyse the data issue trend at site and then support on the systematic data issue solution.

· Coordinate the medical data review process and manage the stakeholders of medical data review.

· Proactively identify the risk of data validation and work out the mitigation plan.

· Provide the study DM status report in the appropriate approach.

- Gain the knowledge of Dizal Clinical Data Standards and work on the relevant activities as necessary.

- Proactively identify the process gap and contribute on the process streamline task.

- Be capable to work on the activity which is authorized by LDM and proactively identify the risk of the delegation and provide the proposal as necessary.

 

Requirement:

l Master degree or Bachelor degree in medical or pharmacy related major

l Good knowledge of clinical trial and GCP and regulatory requirement in terms of data management systems and activities

l Fluent English skill

l Proactive communication with others

l Can do attitude

l Open mind to learn new things

l Certificated SCDM is preferred

 

 

职位：Clinical Trial Assistant 临床试验助理

部门：Clinical Operations 临床运营部

专业：Pharmacy & Medical Related 药学，医学相关专业

学历：Bachelor and above 本科及以上

地点：Shanghai上海

人数：1人

Responsibility
Role & Responsibility

· Contribute to clinical study start-up, execution, close-out and reporting at country and/or site level.

· Assist local study team with preparation, handling, distribution, filing and archiving of clinical documentation and reports according to company policies and SOPs.

· Maintain Trial Master File (TMF) at country and/or site level per the scope of work. Assist with periodic review of study files for completeness. Preparation for relevant QC checks when applicable.

· Track site compliance and performance per study timelines via Clinical Systems (e.g. eTMF, CTMS, EDC, IRT system).

· Manage, coordinate, and track study materials, equipment and cost at country and/or site level. Track site budget related matters, including processing invoices, tracking payments, updating relevant trackers, coordinating the translation of required documents.

· Lead the practical arrangements and contribute to the preparation of internal and external meetings e.g. local study team meetings, monitor meetings, Investigator meetings. Liaise with internal and external participants and/or vendors at country and/or site level.

· Coordinate administrative tasks during the study process, audits and regulatory inspections, according to company policies and SOPs.

· Provide input into non-drug project work including training activities, meeting events and development of work instructions as needed.

· If needs arise, may support CRAs for on-site visits to assist with clinical monitoring duties upon completion of required trainings and with required approval. May perform assigned administrative tasks at study level.

· Ensure compliance with company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).

· Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software

· Identify and report quality issues along with corrective and preventive actions to Local study leader/equivalent esp when its related to any data privacy, serious breaches and/impact to the reputation of company and safeguard patients\' rights and wellbeing.

 

Requirement

· Education

Pharmacy & Medical Related 

Bachelor and Above 

· Level of education that supports Skills and Capabilities of the position and ensures successful conduct of accountabilities/responsibilities and appropriate interactions with internal/external customers

· Ability to develop advanced computer skills to increase efficiency in day-to-day tasks

· Good verbal and written communication and presentation skills

· work accurately, being proactive, independent and working in a team

· Ability to prioritise and manage multiple tasks with conflicting deadlines

· Good interpersonal skills and ability to work in a team environment

· Willingness to travel both domestically and internationally

· Proactively identify risks and possible solutions

· Ability to prepare presentation materials

· Demonstrate professionalism and mutual respect

· Willingness and ability to train others on study administration procedures

· Display excellent organization and time management skills,

· Computer proficiency

· Good knowledge of spoken and written English

 

 

职位详情

学历要求：硕士及以上

工作地点：上海市黄浦区

每月薪水：6000-7000

招聘人数：5 人

行业：科学研究和技术服务业

性质：三资企业

所在地：上海市浦东新区

联系人：姚艺双

简历接收邮箱：

QQ：

简历接收邮箱： Crystal.Yao@dizalpharma.com