Associate Director, Clinical Biomarkers in Basking Ridge, New Jersey at DSI

Date Posted: 2/10/2020

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years & Counting!

With over 100 years of scientific expertise & a presence in more than 20 countries, Daiichi Sankyo & its 15,000 employees around the world draw upon a rich legacy of innovation & a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension & thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research & development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart & kidney diseases, & other rare diseases.

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:

Leads limited project specific TMCP teams; works on medium trials, biomarker analysis, and technologies

Applies guidelines for assay validation and QC; monitors compliance

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

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

Executes, analyzes, interprets data for ex-vivo/in-vitro studies

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

Provides limited contributions to portfolio, Support assessment of BD opportunities as necessary

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:
  • Education: PhD, MD/VMD (for pathology)
  • Experience: 6+ years industry experience

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.