Associate Director, Clinical Pharmacology

Alnylam Pharmaceuticals•Cambridge, MA

8d•$175,800 - $237,800•Hybrid

About The Position

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

Requirements

Ph.D. ( or Pharm.D.) in relevant field (i.e. Pharmacokinetics, Pharmacometrics, Clinical Pharmacology) with atleast 5 years’ 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)

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
Network with external expert consultants, CRO partners and academic sites to problem solve and develop scientific solutions to clinical pharmacology issues