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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. 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 Associate Director, Quantitative Systems Pharmacology (QSP) will work within the Quantitative Clinical Pharmacology (QCP) group to develop and apply QSP models to aid in drug discovery/development decisions, which include target prioritization, therapeutic modality selection, biomarker characterization and clinical trial design.  In addition, he/she will develop a QSP strategy to address prioritization across the portfolio of compounds within Oncology/Immuno-Oncology.  This position requires internal/external cross-functional collaboration to develop and apply QSP models across a portfolio of therapeutic compounds.  This includes working with scientists in Research, Translational Science, Clinical Development, in addition to colleagues in QCP.  QSP Scientists have the opportunity to work within the QSP Model Development Team (MDT), a formal cross-functional framework for collaborative development and application of QSP within Oncology/Immuno-Oncology.

Responsibilities

• Develop and apply Quantitative Systems Pharmacology (QSP) models to address drug-discovery and development questions
• Develop a QSP strategy to address prioritization across the portfolio within Oncology/Immuno-Oncology
• Collaborate with multidisciplinary project teams to develop and apply QSP models to aid in target prioritization, therapeutic modality selection, biomarker characterization and early clinical trial design
• Interact with, and possibly lead, cross-functional QSP MDT to develop and apply QSP within Oncology/Immuno-Oncology
• Develop and rigorously assess the functionality, feasibility, efficiency and validity of new models
• Conduct extensive literature review to identify suitable mechanistic elements, interactions, rate constants and sub-modules for incorporation into systems (disease) models
• Contribute to the design, execution and interpretation of clinical and non-clinical studies.
• Partner with external groups to accelerate and supplement the internal QSP efforts in key disease indications
• Maintain effective collaboration with internal/external stakeholders across diverse functions to facilitate model development and application.
• Align QSP model deliverables with the Model-Based Drug Development (MBDD) plans
• Utilize virtual population workflows and script-based analysis packages to generate clinically relevant hypotheses to inform clinical development programs
• Stay informed with emerging literature and science in the systems biology/pharmacology modeling and simulation sciences
• Build and maintain a personal track record of publication in the area of QSP

Qualifications: Reasonable consideration will be given to candidates with greater experience/qualifications in some areas as compared with others.

Education Qualifications (from an accredited college or university)

Ph.D. in Engineering, Mathematics, Bioinformatics, Pharmacometrics, Systems Biology/Pharmacology or a related field with a proven record of productivity as demonstrated by publications and conference presentations - required

Experience Qualifications

• 3 or more years experience in industry/consulting developing and applying QSP/Systems Biology models
• Understanding of theory, principles and statistical aspects of advanced mathematical modeling and simulation, including numerical methods, parameter estimation/optimization, ordinary differential equations (ODEs) and how these can be applied in the development of complex models of biological pathways/systems
• Experience with strategic application of QSP to address questions in Pharmaceutical R&D
• Excellent oral and written communication skills and the ability to interact effectively with scientists in other disciplines with a positive, collegial and collaborative attitude
• Knowledge of the basic principles of pharmacokinetics and pharmacodynamics
• Ability to quickly learn new areas of biological sciences and build on solid foundation of quantitative skills to develop QSP models
• Some experience in the design of clinical and non-clinical studies used to inform gaps in knowledge to support improved understanding of disease/drug mechanisms to support QSP model development
• Experience with modeling software(s) such as Matlab/SimBiology and Julia is required
• Experience with large-scale disease platform and virtual population workflow is desirable
• Experience with general programming and data analysis tools/languages such as Python or R would be particularly desirable
• Desire to interact as a modeling and simulation expert across clinical development teams with experts from different functional areas in Research and Development
• Familiarity with the challenges and general application of mathematical modeling/simulation in pharmaceutical R&D

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.