Director, Pharmacometrics
Daiichi Sankyo, Inc.

Job Info

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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/PD modeling with pooled data from Phase 13 studies, perform clinical trial simulations of Phase 2 and 3 studies, and write M&S reports for these analyses. This position demonstrates significant knowledge of pharmacometric modeling, PK/biomarker data, derived analysis-ready data files in Phase 1, complex disease models, regulatory guidelines pertaining to M&S, and programming and analytical software. This position works independently on complex studies/models and interacts effectively with CRO, regulatory agencies, and colleagues.

Responsibilities:

• Analyzes and presents Pooled Phase 13 studies while delivering best practice elements and driving global standards
• Simulates Phase 2 studies; characterizes the time course of disease progression for complex disease modalities
• Provides comments to regulatory agencies regarding draft guidelines for M&S report
• Sets up and implements virtual patient, shell baseline experiments
• Writes M&S reports for early patient studies
• Effectively works independently on complex studies/models while interacting effectively with CRO 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 complex cellular networks
  
  Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
  
  Education/Experience:
  
  PharmD with a clinical pharmacology research fellowship required or PhD in pharmacology or pharmaceutical sciences required
  

• 4 or more years of industry experience required
• 1 or more years Oncology drug development experience preferred
  
  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.

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