Sr Director Modeling & Simulation QCP

Location
Basking Ridge, NJ
Posted
Aug 23, 2019
Ref
9539BR
Hotbed
Pharm Country
Required Education
Masters Degree/MBA
Position Type
Full time
Job Summary:
The purpose of this position is to analyze Pop PK/PD pooled Phase 1-3 studies, design Phase 3 studies, devise computational programs, write M&S summary documents, and plan analysis and resource requirements. This position demonstrates advanced knowledge of pooled Phases 1-3 studies including biomarkers, validated derived analysis-ready data files across therapeutic areas and clinical development phases, complex disease models and therapeutic intervention, regulatory guidelines, and programming and analytical software. This position works independently on Phase 1-3 studies across therapeutic areas while interacting effectively with colleagues.

Responsibilities:
  • Analyzes and presents pooled Phase 1-3 studies including biomarkers; plans analysis needs, assesses resource requirements, prioritizes requests, tracks and reports progress of analysis ready data file production
  • Provides input to design of Phase 3 studies and predicts probability of success; characterizes the time course of disease progression under the influence of therapeutic intervention
  • Implements regulatory guidelines into study design and data analysis
  • Devises computational program to describe the relationships between the biological systems and the outcome in a virtual patient
  • Writes and reviews M&S summary documents
  • Effectively works independently on Phase 1-3 studies across therapeutic areas while interacting effectively with colleagues to plan analysis needs, assess resource requirements, prioritize requests, track and report progress of analysis ready data file production
  • Interacts with and influences the complexities related to multiplicity of interactions between drug bound target and complex cellular networks
Qualifications:
Education and Experience
PhD with a minimum of 8 years of industry experience, or MS with 10 years of industry experience or equivalent
Has knowledge of the following systems: NONMEM, R, PsN, XPose, WinNONLIN (Phoenix), WinBUGS, MONOLIX

Job Title
Sr Director Modeling & Simulation QCP

City
Basking Ridge

Functional Area
QCP

State
New Jersey