美国招聘DMPK Director/SD, homework

公司背景：

创始团队大多来自欧美大型药企，已完成数亿元的融资。

公司的研发管线为中美双报的全球新小分子新药用于自免疫疾病和肿瘤治疗，在美国和中国都建立有研发中心。

We are seeking a talented Director or Sr. Director to lead the DMPK and interact with research and development teams to advance  programs.  This position has responsibility to ensure that DMPK assessments for research compounds are conducted to support advancement to development candidates and to progress development candidates to registrations.  The Head of DMPK is also responsible for overseeing the preparation of DMPK sections of regulatory submissions and serves on project teams.

Key responsibilities include:

1. Oversees and is responsible for all DMPK activities  

2. Develops close, collaborative working relationships across functions especially with toxicology, clinical, and pre-clinical pharmacology groups

3. Responsible for ensuring collaboration of DMPK team representatives with clinical colleagues to ensure integration of DMPK insights into clinical programs and alignment of nonclinical DMPK and clinical activities related to drug metabolism and pharmacokinetics

4. Ensures adequate DMPK representation on project teams in research and development

5. Collaborates with research to develop critical pathways to select development candidates

6. Designs and oversees conduct of DMPK studies that support clinical trials and product registration

7. Provides oversight for preparations of DMPK portions of regulatory submissions (IND) and clinical documents (IB)

8. Interacts with regulatory agencies on drug metabolism and pharmacokinetic issues related to development projects

9. Critically evaluates project data while rigorously driving data-driven Go/No-go decisions, including the identification of resource constraints and bottlenecks

10. Promotes an overall group culture of agility, pro-action, collaboration, and innovation 

Requirements:

1. PhD and Experience in the pharmaceutical industry (8+ years)

2. Ability to work with interdisciplinary teams

3. Communicates in a clear and concise manner to both internal and external

4. Excellent organizational and time management skills

5. Experience preparing regulatory submissions and supportive documents

6. Demonstration of highly successful project execution across disease areas using in-house and/or CRO resources leading to preclinical candidates for further clinical development

7. Impeccable attention to detail, and excellent ability to perform hands on experiments, research/design/organize projects and maintain detailed documentation

8. Able to provide leadership on a cross-functional team

9. Strong organizational skills and the ability to manage multiple tasks

10. Possess effective verbal, written, and interpersonal communication skills

11. Strong understanding of the drug discovery process and demonstrated leadership on cross-functional teams

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