• 招聘类型：社招
• 工作性质：全职

职位描述

Job Description

1. Play a leadership role in preclinical and early clinical studies, including but not limited to in vitro and in vivo ADME assays, PK/TK support, M&S;

2. Represent DMPK function in cross functional project team (toxicology, pharmacology, clinical development, CMC and others). Provide critical feedbacks to project teams from DMPK point of view;

3. Serve as the lead person for regulatory related activities in DMPK areas for Simcere R&D and contribute to generating and reviewing documents such as investigator’s brochures, INDs, CTA’s, and BLAs/MAA’s and provide scientific support on all licensing activities;

4. Manage collaborations with CRO/CMO for outsourcing activities. Provide interim and final deliverables within project timeline and budget requirements;

5. Work with other senior staff of Preclinical R&D to set the direction and tone for experimental approaches for DMPK issues within the organization;

6. Play as a key member of NCS management team, contribute to department development, budget and people development;

7. Responsible for ensuring reporting timeline for all DMPK related reports. Expected to review, edit, and offer critical feedbacks to the reports generated by CROs or subordinates.

任职条件

Requirements

1. Ph.D. or equivalent in a relevant discipline;

2. 6+ years of industrial experience, ideally within both large pharma and biotech, with 3+ years of experience of project leader or project representative;

3. Hands-on experience of DMPK project support;

4. Experience with preparation of regulatory documents, such as IND, NDA/BLA, CTD, etc.;

5. Broad background knowledge in DMPK with strong expertise in at least one DMPK area, preferably drug metabolism or M&S;

6. Working knowledge of DMPK related regulations and regulatory guidelines from ICH, FDA, EMA, and CFDA;

7. Be able to establish/maintain working relationship throughout the organization and external collaborators, such as CROs, universities, research institutes, and regulatory agencies;

8. Excellent presentation and communication skills.

职位要求

• 学历要求：博士
• 工作经验：6年
• 外语要求：不需要