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)