Associate Director, Modeling & Simulation in Basking Ridge, NJ at DSI

Date Posted: 9/23/2020

Job Snapshot

  • Employee Type:
    Full-Time
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    9/23/2020
  • Job ID:
    10495BR

Job Description

Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Job Summary:

The purpose of this position is to perform Population PK and PK/PD modeling with pooled data from Phase 1 to 3 studies, conduction PK and PK/PD simulations, and write M&S reports for these analyses. This position demonstrates significant knowledge of pharmacometrics models, PK/biomarker data, derived analysis-ready data files, regulatory guidelines pertaining to M&S, and programming and analytical software. This position works independently on pharmacometrics activities and interacts effectively with CRO, regulatory agencies, and colleagues.

Responsibilities:
  • Analyzes and presents analysis results of pooled Phase 1-3 studies while delivering best practice elements and driving global standards
  • Conduct PK and PK/PD simulations
  • Provides comments to regulatory agencies regarding draft guidelines for M&S report
  • Writes M&S reports for early patient studies
  • Works independently on pharmacometrics activities; interact effectively with CRO’s to implement concept of virtual patient as well as regulatory agencies regarding guidelines; interacts with colleagues to deliver Best Practice elements and drive global standards in PK/PD M&S analysis ready data file production
  • Interacts with and influences the multiplicity of interactions between drug bound target and complex cellular networks

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:

MS, PhD
3+ years (PhD) or 5+ years (MS) of industry experience

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.