Associate Director, Clinical Pharmacology

Associate Director, Clinical Pharmacology

Alnylam Pharmaceuticals

Amsterdam or Maidenhead

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)