Associate Director, Clinical Pharmacology

<p>The Associate Director in Clinical Pharmacology position will support a rapidly expanding clinical portfolio of promising RNAi therapeutics in CNS.

The candidate in this position should be well versed in clinical pharmacology, PK and PD with strong ability to critically evaluate and interpret data and conduct data analysis.

In this role, the candidate is expected to have a strong critical thinking ability with good oral and written communication.

Habilidades

This is a virtual role based in the UK. 

Key

Responsabilidades

• 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

Calificaciones

• Ph.D. ( or Pharm.D.) in relevant field (i.e

  Pharmacokinetics, Pharmacometrics, Clinical Pharmacology) with in depth experience in pharmaceutical/biotech industry</li> <li>In depth knowledge of clinical pharmacology, pharmacokinetics, modeling and simulation, PK/PD principles, ADME and clinical data interpretation</li> <li>In depth knowledge of international guidelines related to Clinical Pharmacology and Pharmacometrics</li> <li>Proficient i.