高级总监, 临床药理学
Associate Director, Clinical Pharmacology
简介
临床药理学高级总监在中枢神经系统（CNS）业务部门快速扩展的RNAi治疗产品组合中提供支持。该职位为临床阶段项目提供临床药理学专业知识，重点关注药代动力学（PK）、药效动力学（PD）以及PK/PD分析，以指导临床开发和监管决策。
该职位需要强大的科学专业知识、批判性思维能力，以及在高度矩阵化的环境中独立解读和整合复杂的临床药理学数据的能力。临床药理学高级总监与研究、临床开发、生物分析、监管、项目管理及其他研发职能紧密合作，为临床研究设计、数据分析、监管提交和科学出版物做出贡献，以推动创新的RNAi疗法发展。
该职位为远程岗位，位于荷兰或英国。
主要职责
- 独立代表临床药理学，为临床阶段项目团队提供临床药理学支持和指导
- 领导临床药理学数据的分析、解释、整合和报告
- 进行PK和PK/PD分析，以指导临床开发决策
- 为监管提交（如简报文件、IND、CTA和NDA）提供临床药理学意见
- 独立准备并输入适当的临床方案、研究者手册、临床研究报告中的相关内容，涉及临床药理学研究或数据
- 与研究、生物分析、临床、监管、项目管理及其他研发职能密切合作
- 准备摘要和论文用于发表
资格要求
- 相关领域（如药代动力学、药理学建模、临床药理学）的博士（或药学博士）学位，并在制药/生物科技行业有深入经验
- 深入了解临床药理学、药代动力学、建模与模拟、PK/PD原理、ADME及临床数据解读
- 深入了解与临床药理学和药理学建模相关的国际指南
- 精通Phoenix WinNonlin、R、NONMEM或其他药代动力学、建模和数据可视化软件
- 在高度矩阵化的团队环境中工作的能力至关重要
- 能够独立工作
- 强大的沟通和演讲能力（口头和书面）
- 优秀的跨部门协作能力
查看英文原文
Overview
The Associate Director, Clinical Pharmacology supports a rapidly expanding clinical portfolio of RNAi therapeutics within the CNS franchise. This role provides clinical pharmacology expertise across clinical-stage programs, with a strong focus on pharmacokinetics (PK), pharmacodynamics (PD), and PK/PD analyses to inform clinical development and regulatory decision-making.
The position requires strong scientific expertise, critical thinking, and the ability to independently interpret and integrate complex clinical pharmacology data within a highly matrixed environment. The Associate Director partners closely with Research, Clinical Development, Bioanalytical, Regulatory, Project Management, and other R&D functions, contributing to clinical study design, data analysis, regulatory submissions, and scientific publications in support of advancing innovative RNAi therapies.
This is a virtual role based in The Netherlands or UK.
Key Responsibilities
- Represent independently Clinical Pharmacology and provide clinical pharmacology support and guidance to clinical stage project teams.
- Lead the analysis, interpretation, integration and reporting of clinical pharmacology data
- Conduct PK and PK/PD analyses to guide clinical development decisions
- Provide clinical pharmacology input for regulatory submissions such as briefing documents, IND, CTA and NDA
- Prepare and input independently appropriate documents or sections of clinical protocols, Investigator Brochures, Clinical Study Reports with respect to Clinical Pharmacology studies or data
- Closely partner with Research, Bioanalytical, Clinical, Regulatory, Project Management, and other R&D functions
- Preparation of abstracts and manuscripts for publications
Qualifications
- Ph.D. ( or Pharm.D.) in relevant field (i.e. Pharmacokinetics, Pharmacometrics, Clinical Pharmacology) with in depth experience in pharmaceutical/biotech industry
- In depth knowledge of clinical pharmacology, pharmacokinetics, modeling and simulation, PK/PD principles, ADME and clinical data interpretation
- In depth knowledge of international guidelines related to Clinical Pharmacology and Pharmacometrics
- Proficient in using Phoenix WinNonlin, R, NONMEM, or other pharmacokinetic, modeling and data visualizations software.
- Ability to function in a highly matrixed team environment is essential
- Ability to work independently
- Strong communication and presentation skills (verbal and written)
- Excellent interpersonal skills and ability to work independently
- Fluency in English (verbal and written)
Why Alnylam?
Join a company recognized for its innovation, open culture, and commitment to people. At Alnylam, you’ll work in an environment that values collaboration, purpose, and excellence — and be part of a team bringing groundbreaking RNAi therapies to patients in need.
Apply now to make a difference where science meets purpose.
Originally posted on Himalayas