Senior Director, Pharmacometrics

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

Education/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

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.

Job Title
Senior Director, Pharmacometrics

City
Basking Ridge

Functional Area
QCP

State
New Jersey