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.
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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.
#J-18808-Ljbffr…