DMPK总监
Director, DMPK
Watton Hall 正与一家领先的生物技术公司合作，该公司专注于开发创新疗法以解决未满足的医疗需求。他们的使命是通过制药行业的前沿研究和开发改善患者预后。
DMPK 部门总监将为我们的药物发现和开发项目提供战略领导和科学专业知识，涵盖药物代谢、药代动力学（PK）和药效动力学（PD）。该职位需要与跨职能团队合作，确保小分子候选药物从临床前到临床阶段的成功推进。
主要职责
- 制定并实施与项目目标一致的 DMPK 策略，确保药物候选物的及时选择和推进。
- 与药物化学、毒理学、临床运营和法规事务团队紧密合作，支持整合药物开发工作。
- 准备和审核监管提交文件（如 IND、NDA 和 BLA）中的 DMPK 相关部分；并回应监管机构的查询。
- 管理与合同研究组织（CRO）的合作，确保研究按时执行，同时保持高质量标准。
- 带领一支科学家团队，提供指导，促进职业发展，并推动创新文化。
职位要求
- 药理学、药物代谢（或相关领域）博士学历
- 具备药物申报的监管要求经验是必需的
- 在设计和开展支持小分子药物开发的 PK 研究方面有成功记录
- 具备出色的沟通能力，能够在快节奏的环境中协作工作
福利
- 根据经验提供具有竞争力的薪资，以及绩效奖金和全面的福利包
- 可选居家办公
- 优秀的公司文化
- 接触充满活力和不断发展的生物科技公司
最初发布于 Himalayas
查看英文原文
Watton Hall are working with a leading biotechnology firm focused on developing innovative therapies to address unmet medical needs. There mission is to improve patient outcomes through cutting-edge research and development in the pharmaceutical industry.
The Director of DMPK will provide strategic leadership and scientific expertise in drug metabolism, pharmacokinetics (PK), and pharmacodynamics (PD) for our drug discovery and development programs. This role requires collaboration with cross-functional teams to ensure the successful advancement of small molecule candidates from preclinical through clinical stages.
Main Responsibilities
- Develop and implement DMPK strategies that align with project goals, ensuring timely selection and progression of drug candidates.
- Work closely with medicinal chemistry, toxicology, clinical operations, and regulatory affairs teams to support integrated drug development efforts.
- Prepare and review DMPK-related sections for regulatory submissions such as INDs, NDAs, and BLAs; and respond to regulatory enquiries.
- Manage partnerships with contract research organizations (CROs) to ensure timely execution of studies while maintaining high-quality standards.
- Lead a team of scientists by providing mentorship, fostering professional growth, and promoting a culture of innovation.
Profile
- PhD in Pharmacology, Drug Metabolism (or a related field)
- Experience with regulatory requirements for drug submissions is essential.
- Proven track record in designing and conducting PK studies supporting small molecule drug development
- Excellent communication skills with the ability to work collaboratively in a fast-paced environment.
Benefits
- Competitive salary commensurate with experience along with performance-based bonuses and comprehensive benefits package
- Home office option
- Excellent company culture
- Exposure to a dynamic and evolving Biotech company
Originally posted on Himalayas