EU remote
Associate Director, Clinical Pharmacology
About this role
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 skills as well as worked independently in a highly matrixed environment.
This is a virtual role based in the 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) About Alnylam: Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases.