Associate Director, Clinical Pharmacology

Alnylam Pharmaceuticals•Cambridge, MA

1d•Hybrid

About The Position

Develop and execute population PK, PK/PD, exposure response, disease progression models, dose selection for phase 3 strategies/plans and corresponding models for the pharmacometric function from early clinical studies through Phase 3 study The incumbent will be responsible for the preparation of population PK/PD analysis plan, reports, and corresponding regulatory submission documents. The incumbent will be expected to manage multiple development projects simultaneously and will participate in discussions and presentations with senior management.

Requirements

A PhD, degree or equivalent in quantitative sciences, background in engineering, or clinical pharmacology is desired.
5+ years pharmaceutical industrial and/or postdoctoral experiences in the related disciplines of clinical pharmacology, and PKPD
Excellent hands-on knowledge in R and/or SAS, NONMEM
Well versed at plotting complex data to identify trends important for drug development
Track record of publishing M&S work
Excellent written and verbal communication skills

Responsibilities

As the M&S project lead on one or more cross-functional development teams, develop and execute M&S strategies and plans fully integrated with the overall preclinical and clinical plans
By using state of the art M&S methodologies strongly contribute to decision making at critical milestones based on quantitative principles in close collaboration with DMPK, Stat, Clin Pharm, Medical Sciences, Research, and other quantitative disciplines
Perform population PK, PK/PD analyses, clinical trial simulations and other model-based analyses when appropriate
Strengthen and build internal M&S capability on a continuous basis by attending trainings, evaluating and introducing new M&S tools and computing platform as appropriate
Prepare population PK/PD reports and corresponding regulatory submission documents.