Associate Director, Clinical Pharmacology

 Posted 4 months ago
     
5-10 years experience
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AI Summary

The Associate Director will provide clinical pharmacology support and guidance to clinical stage project teams, leading the analysis and reporting of clinical pharmacology data. They will also conduct PK and PK/PD analyses to guide clinical development decisions and prepare regulatory submission documents.

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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