Director, Clinical Pharmacology

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 primary responsibilities of this position are to create the model-based drug development plan, design, conduct, and interpret Phase 1 (specifically Clinical Pharmacology) studies, support Phase 2/3 studies, represent function on study and project teams, and participate in and contribute to regulatory and KOL meetings. This position requires significant understanding of PK-PD and Pop PK-PD concepts and analysis, phase 1-4 clinical studies, literature, regulatory guidelines, and physiological/pharmacological aspects of the drug. This position effectively works independently for all phases of studies and participates in KOL and regulatory interactions at a project level, and interacts with regional and global project team members, senior management, and outside vendors.

Responsibilities

• Responsible for all aspects of Clinical Pharmacology and Biopharmaceutics studies and model-based drug development plans, serves as QCP subteam leader / clinical pharmacology project team representative, supports Phase 2/3 clinical pharmacology objectives with high-level supervision, participates in due-diligence activities, and represents global function on study and project teams
• Produces independent writing for publications and regulatory documents
• Serves as a specialist in PK-PD and Pop PK-PD concepts and independently performs PK-PD analyses, functions as Study Team Leader for Phase 1 Clinical Pharmacology studies and provides clinical pharmacology input and support for other phase 1-4 clinical studies. Maintains up-to-date knowledge of relevant literature and regulatory guidelines
• Participates in KOL and regulatory interactions at project level, interacts with regional and global study and project team members, and to a limited extent with senior management and outside vendors
• Mentors more junior department members, and provides information sharing within and between departments
  
  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)
  PharmD In pharmacology or pharmaceutical sciences required or PhD With a clinical pharmacology research fellowship required
  
  Experience Qualifications

• 4 or More Years Industry experience required and
• 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.

Job Title
Director, Clinical Pharmacology

City
Basking Ridge

Functional Area
QCP

State
New Jersey