Director, Modeling and Simulation in Bernards, NJ at DSI

Date Posted: 7/30/2018

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!

With over 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 hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

Job Description:

The purpose of this position is to conduct population PK/PD analysis for pooled Phase 1 studies, perform trial simulation for Phase 2/3 studies, and write M&S reports. This position demonstrates significant knowledge of pooled Phase 1 studies, PK/PD and biomarker data, PK/PD analysis-ready data file derivation, complex disease modalities, regulatory guidelines pertaining to M&S, and programming and analytical software. This position works independently on complex studies/models and interacts effectively with project team members, CRO, and regulatory agencies.

Responsibilities:

Analyzes and presents pooled Phase 1 studies while delivering best practice elements and driving global standards

Conducts trial simulations for Phase 2/3 studies; characterizes the time course of disease progression for complex disease modalities

Writes M & S documents (e.g. M&S report, analysis plan, dataset specification)

Works independently on complex studies/models while interacting effectively with internal colleagues, external CROs, as well as regulatory agencies

Qualifications:
  • PhD with a minimum of 6 years of industry experience, or MS with 8 years of industry experience or equivalent
  • Proficiency in quantitative analyses (including population PK, PK/PD, exposure-response, and drug-disease modeling) and clinical trial simulations
  • Prior experience in applying modeling and simulation to clinical development of oncology products, particularly ADCs
  • Familiarity with following systems: NONMEM, R, PsN, Xpose, WinNONLIN (Phoenix)
  • Solid proficiencies in written and verbal communication, interpersonal skills, problem scoping and planning, and the ability to participate in interdisciplinary teams.
Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All 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.