Manager, Quantitative Clinical Pharmacology
Daiichi Sankyo, Inc.

Job Info

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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

This position will be part of the Quantitative Clinical Pharmacology (QCP) team and support drug development and commercialization activities. It is accountable for the Clinical Pharmacology and Model-Based Drug Development (MBDD) plans and deliverables. The primary responsibilities of Clinical Pharmacology are to establish PK/PD/efficacy/safety relationships in the clinical setting, to drive the development of potential products and drug candidates. The Manager, Clinical Pharmacology will support or take the lead on generation of study designs, protocols, reviews and authoring reports and co-authoring primary and secondary sections of regulatory documents. The Manager, Clinical Pharmacology is expected to identify, generate and execute study protocols with external CROs, collaborate and represent QCP on internal teams including Clinical Development Operations, Global Project Management, Bioanalysis, and Drug Metabolism to design, develop, implement and monitor execution of strategies as well as short- and long-term experiments to advance clinical development.

Responsibilities:

• Serve as QCP representative on Clinical studies or take a lead on Clinical pharmacology studies.
• Serve as QCP sub-team leader and represent the QCP function at project teams.
• Perform modeling and simulation in support of clinical development of drug candidates.
• Maintain exploratory modeling and simulation workflows. Perform quality checks on modeling conducted by other scientists.

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)

• Bachelor's Degree in Life Sciences, Pharmacy or Nursing is required.
• Advanced degree in a related field (MS, MPH, PhD or Pharm. D higher) preferred.

Experience Qualifications:

• 4 or more years with a BS degree preferred.
• 4 or more years with a MS degree preferred.
• 1 or more years with a doctoral degree preferred.
• Experience in clinical development and performing modeling and simulation required.

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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