Manager, Pharmacometrics

Location
Basking Ridge, NJ
Posted
Oct 08, 2021
Ref
R13
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time

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.

Summary

The purpose of this position is to analyze single Population PK/PD Phase 1 to 3 studies, simulate multiple dose scenarios, and write M&S study report for Phase 1 to 3 studies. This position demonstrates general knowledge of Phase 1 studies and multiple dose scenarios, PK/PD M&S analysis data structures and analysis tools requirements, simple disease models, regulatory guidelines pertaining to M&S, and programming and analytical software. This position works with moderate supervision in simpler studies/models and interacts with internal project teams.

Responsibilities

  • Analyzes and presents M&S Analyses of Phase 1 - 3 studies
  • Simulates multiple dose scenarios; characterizes the time course of disease progression using relatively simple disease models
  • Writes M&S study reports for Phase 1 to 3 studies
  • Interacts effectively on internal project teams as well as with moderate supervision in simpler studies/models
  • Works with and influences the interactions between candidate drug and its immediate target

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

Education Qualifications (from an accredited college or university)

PhD In pharmacology or pharmaceutical sciences required or
PharmD With a clinical pharmacology research fellowship required

Experience Qualifications

  • 1 or More Years Industry Experience required and
  • 1 or More Years Experience with the following systems: NONMEM, R, PsN, XPose, WinNONLIN (Phoenix), WinBUGS, MONOLIX
    preferred

Travel

Ability to travel up to 10%

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.