Associate Director, Clinical Biomarkers in Bernards, NJ at DSI

Date Posted: 2/19/2018

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo, Inc. is the U.S. subsidiary of Daiichi Sankyo, Co., Ltd. The Company currently markets therapies in hypertension, dyslipidemia, diabetes, acute coronary syndrome, thrombotic disorders, stroke risk reduction, opioid-induced constipation, IV iron therapy and metastatic melanoma.

Job Summary

The primary responsibilities of this position are to lead project-specific TMCP sub-teams, provide support and strategy for the development biomarker assays, and analyze and interpret raw data and results. This position has an understanding of the biomarker discovery through CDx development process.

Responsibilities

1. Leads limited project-specific TMCP teams; works on medium trials, biomarker analysis, and technologies
2. Applies guidelines for assay validation and QC; monitors compliance
3. Qualifies technology for biomarker support what does this entail?
  • Identifies novel or existing technologies that are clinically appropriate for biomarker assay development
  • Identifies appropriate preclinical or clinical tools to validate the technology
  • Designs experiments to qualify the technology for clinical applications
4. Collects and provides regulatory documents what does this entail?
  • Manages Biomarker related documents as defined by DS policies and guidelines
    • Provides significant input in and finalize assay validation reports
    • Provides significant input in and finalize Biomarker study reports
5. Executes, analyzes, interprets data for ex-vivo/in-vitro studies
6. Establishes project-based relationships with Laboratory providers please expand
  • Provides a single point of contact for a project or clinical program
    • Identifies laboratories that can provide centralized services for many studies within a development program
    • Reviews and executes contracts and invoices to ensure work was completed
    • Keep track of budget and payments
7. Provides limited contributions to portfolio, Support assessment of BD opportunities as necessary

Qualifications

Education: PhD, MD/VMD (for pathology)

Experience: 6+ years industry experience

Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All 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.