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Director Clinical Pharmacology in Bernards, NJ at DSI

Date Posted: 5/5/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Bernards, NJ
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    5/5/2019
  • Job ID:
    9586BR

Job Description


About Daiichi Sankyo Cancer Enterprise

The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA.


Job Summary:

The primary responsibilities of this position are to create the model-based drug development plan, design, conduct, and interpret Phase 1 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 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; clinical pharmacology project lead; 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 & regulatory documents
  • Serves as a specialist in PK-PD and Pop PK-PD concepts, phase 1-4 clinical studies, literature, and regulatory guidelines and can conduct/develop PK-PD and Pop PK-PD analyses,
  • Serves as a specialist in PK-PD and Pop PK-PD concepts, phase 1-4 clinical studies, literature,and regulatory guidelines and can conduct/develop PK-PD and Pop PK-PD analyses,
  • 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; works independently for all phases of studies
  • Mentors direct reports and department; responsible for performance management and development of a limited number of employees
  • Responsible for all aspects of all studies; clinical pharmacology project lead; 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
  • diligence activities and represents global function on study and project teams

Qualifications:

Education:
  • Bachelor’s degree and Master’s degree, PhD or PharmD
Experience:
  • 7+ years industry experience