Associate Director, Companion Diagnostics Lead

3 days ago

Basking Ridge, New Jersey, United States BioSpace, Inc. Full time
Job Summary

The Associate Director, Companion Diagnostics Lead will play a key role in guiding the strategy and leading the implementation of companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late-Stage Development Portfolio.

This position will contribute to CDx project teams for the diagnostic, under the direction of the Global Program Teams (GPT) CDx representative for the therapeutic or under the guidance of the CDx portfolio leader, covering all areas from CDx assay development through CDx approval and launch.

The individual will collaborate closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads, and Regulatory Liaisons to ensure successful implementation of CDx and data collection.

This role will also support Regulatory affairs in providing content and reviewing documents supporting CDx submissions to the FDA and other health authorities globally.

Qualifications
  • PhD in Life Sciences or a related discipline (preferred)
  • MS degree in Life Sciences or a related discipline (required)
  • Minimum 3 years of relevant work experience with a PhD or 5+ years of relevant work experience with an MS
  • Demonstrated track record of success working on multidisciplinary pharmaceutical/diagnostic development teams
  • Understanding of the IVD Development Process, with indirect or direct experience with Companion Diagnostics Development
  • Broad knowledge and understanding of established and new assay technologies such as NGS, IHC, PCR, etc.
Competencies
  • Ability to work in a highly collaborative environment globally with stakeholders from multiple functional areas
  • Strategic and analytical skills with a proven ability to define, prioritize, and balance responsibilities in accordance with business and team needs
  • Experience maintaining strategic direction while ensuring successful execution of project details
  • Solid interpersonal and verbal and written communication skills with the ability to effectively communicate within project teams and at managerial levels of the organization across various functions and locations
What We Offer

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.

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