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Director, Quantitative Clinical Pharmacology

Company: Daiichi Sankyo
Location: Basking Ridge
Posted on: November 25, 2022

Job Description:

SummaryThe 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 departmentsQualifications: 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 requiredExperience Qualifications
      • 4 or More Years Industry experience required and
      • 1 or More Years Oncology drug development experience preferred

Keywords: Daiichi Sankyo, Newark , Director, Quantitative Clinical Pharmacology, Executive , Basking Ridge, New Jersey

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