Senior Scientist Clinical Biomarkers

Join a Legacy of Innovation 110 Years and Counting!

With over 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. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group's 2025 Vision to become a "Global Pharma Innovator with a Competitive Advantage in Oncology," Daiichi Sankyo research and 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 and kidney diseases, and other rare diseases.

Job Summary:

The primary responsibilities of this position is to represent TMCP on project teams, participate and provide project team support for the development of fit-for-purpose biomarker assays, and ensure assay validation and QC are acceptable.

Responsibilities:

• Participates in small trials, biomarker analysis, and technologies. May review protocol and provide information to the teams. Provides sample handling specifications and collection
• Applies guidelines for assay validation and QC; monitors compliance
  • Reviews QC data from each analytic run and makes sure that the requirements and criteria for acceptance defined by the biomarker lead are fulfilled
• Qualifies a biomarker assay lab with advice from technical experts
  • Identifies potential laboratory partners
  • Organizes vendor presentations and internal follow up
  • Obtains and evaluates documents to assess and qualify a biomarker vendor as directed by the biomarker lead
• Collects and provides regulatory documents
• Manages Biomarker related documents as defined by DS policies and guidelines
  • Finalize assay validation reports
  • Finalize Biomarker study reports
  • Transfer reports to CDR
• Maintains relationships with Laboratory/DX providers with guidance from clinical biomarker lead
• Provides a single point of contact for an assay
  • Communicates and refines scope of work
  • Fills out forms necessary to initiate contracting and QA review
  • Follows up with laboratories until execution of contract work is executed
  • Reviews invoices to ensure work was completed as determined by biomarker lead
  • Keeps track of budget and payments

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

Education/Experience:

• PhD, MD/VMD (for pathology)

• 4+ years industry experience

Ability to travel up to 10%

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
Senior Scientist Clinical Biomarkers

City
Basking Ridge

Functional Area
Global Oncology R&D

State
New Jersey