Associate Director, Companion Diagnostics Lead

2 weeks ago

San Francisco, California, United States Daiichi Sankyo, Inc. Full time
Companion Diagnostics Lead Job Summary

Drive Precision Medicine with Daiichi Sankyo

Daiichi Sankyo, Inc. is a global pharmaceutical innovator dedicated to creating and supplying innovative therapies to improve standards of care and address unmet medical needs. As a Companion Diagnostics Lead, you will play a key role in guiding the strategy and implementing companion diagnostics (CDx) in support of projects within our Early and Late-Stage Development Portfolio.

Key Responsibilities:

  • Contribute to CDx project teams, collaborating with Global Program Teams (GPT) and CDx portfolio leaders to develop and implement CDx assays, ensuring successful approval and launch.
  • Evaluate and select CDx partners, managing multiple partnerships with diagnostic companies.
  • Provide scientific and technical expertise, working closely with Translational Science Leads, Clinical Biomarker Leads, and Regulatory Liaisons to ensure CDx implementation and data collection.
  • Support Regulatory affairs in providing content and reviewing documents for CDx submissions to the FDA and other health authorities globally.
  • Develop and execute diagnostic development strategies for late-stage programs, staying up-to-date with regulatory and policy updates.

Requirements:

  • PhD in Life Sciences or related field (preferred) or MS degree in Life Sciences or related field (required).
  • Minimum 3 years of relevant work experience with PhD or 5+ years with MS.
  • Demonstrated track record of success in multidisciplinary pharmaceutical/diagnostic development teams.
  • Understanding of IVD Development Process and Companion Diagnostics Development.
  • Broad knowledge of established and new assay technologies.
  • Competencies: collaboration, strategic thinking, analytical skills, and effective communication.

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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