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DMPK AD
上海市
2024-04-28


Seniority level职位级别 中高级
Industry公司行业 生物技术
Employment type职位性质 全职
Function工作职能
Number招聘人数 1
Responsibilities(职位描述)

瓴方 DMPK AD岗位:20231116 HR Cici:liangxinxin@lingfangtech.com

一年前看过人,不过那会CSO没到岗,所以停掉了。
注意:下次要推荐人,先跟HR确认一下明确需求再推荐,HR比较介意。

覆盖临床前*临床PK项目,不带人
硕士博士,不受限制,英文读写可以,可以讲是加分。

1个Preclinical ,肿瘤,小分子,4个临床1期左右项目阶段。
岗位没有定预算,要看DMPK AD,D/SD先不考虑。
之前面试30多个人,80多万偏向管理,60和80差不了太多。
估计给不了太高预算,60-70较为合理,90HR觉得太高了。

第一轮:CSO,第一轮是主体主题演讲 ,介绍自己的情况,过往经历等,视频面试
第二轮:临床部门和其他的部门,线上或者线下,也要做主题演讲,考虑综合能力。
第三轮:CEO,线下

Requirements(任职要求)

DMPK Expert Leader (Associate Director or Director)

Roles and responsibilities

The incumbent will lead/represent the DMPK functions and report directly to the CSO (at the interim).

In collaborations with multi-disciplinary R&D teams the incumbent is responsible for developing and implementing DMPK strategies and approaches to drive key project decisions for advancing R&D pipeline with the following duties:
• Lead the design and execution of pre-clinical and clinical PK/PD studies. Analyze, interpret, and model pharmacokinetic/pharmacodynamic, safety, efficacy, and dosimetry data (independent to CROs’ for internal verifications) to support all preclinical and clinical development
• Serve as the primary contact for DMPK function, responsible for qualifying CROs for PK/PD testing and data analysis, coordinating in vitro and in vivo DMPK studies, monitoring and managing all outsourced DMPK activities and facilitating on-time and on-budget delivery of quality results from the CROs
• Collaborate and communicate with internal and external stake holders for PK/PD data interpretation and any trouble shooting for decision-making
• Support drug target selection and BD activities including technical due diligence: Serve as the DMPK subject matter expertise in the evaluation of experimental design and data interpretation related to the in vitro and in vivo preclinical and clinical PK/PD studies.

Qualifications

• PhD (or Master degree with equivalent industrial experience) in pharmacology or related discipline, with 5+ years’ direct experience in formulating/executing pre-clinical and clinical PK/PD strategies, and/or in designing, leading in vitro and in vivo pre-clinical and clinical PK/PD studies, conducting PK/PD modeling/ simulation, and interpretating PK/PD results for drug development, ideally for cancer drugs
• Hands on experience of using specialist tools for DMPK modeling, and track record of leading/supporting PK, PD aspects of R&D projects
• Extensive technical knowledge of DMPK science with a proven ability to delineate the impact of chemical structure on measured properties, and/or experience in different modeling technologies/methods, the pros/cons of each methodology, and its potential applications for different phases of preclinical and clinical development is highly desirable
• Experience of DMPK with a variety of therapeutic formats and different forms of drug formulation and admirations, e.g., for small molecules vs. for biologics, are highly desirable
• Expert experiences in IND/NDA regulatory filings are highly desirable
• Practical experience of DMPK assay delivery including experimental design, assessment of assay performance and analytical validations, and troubleshooting of data issues is highly desirable
• Comprehensive understanding of drug discovery and development and how DMPK studies contribute to successful drug development is essential. Experience in DMPK functional roles from preclinical to all phases of clinical development (phase 1 – 3) and regulatory approval is highly desirable.
• Excellent interpersonal skills, and ability to work in cross-functional teams as well as strong scientific leadership skills
• Can-do attitude with ability to adapt and meet timelines and budget target

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