Companion Diagnostic Lead

1 week ago


Boston, Massachusetts, United States BioSpace, Inc. Full time
Job Title: Companion Diagnostic Lead

We are seeking a highly skilled Companion Diagnostic Lead to join our team in the Oncology Therapeutic Area. As a key member of our Precision and Translational Medicine function, you will be responsible for leading the development and execution of companion diagnostic strategies for early-stage oncology programs.

Key Responsibilities:
  • Develop and deliver diagnostic workplans to ensure efficient and effective test development and deployment in global clinical trial settings.
  • Interface with key internal stakeholders and external diagnostic partners to drive technical assessment of assay/device analytical and clinical validation.
  • Identify and partner with companion diagnostic companies to develop, file, and launch CDx / devices globally in alignment with therapeutic program development and commercial objectives.
  • Support business development initiatives and due diligence teams.
  • Contribute to the development of global diagnostic regulatory submissions and respond to health authority questions.
Requirements:
  • PhD in cancer biology, genetics, molecular biology, pathology, or a related field with 3+ years of experience or a MS with 5+ years of experience in the pharmaceutical, biotech, or diagnostic industry.
  • Oncology experience required.
  • Experience in developing and delivering companion diagnostic work plans, assessing assay/device validation data packages, and supporting regulatory submissions.
  • Successful track record leading CDx / in vitro diagnostics (IVD) development programs.
  • Experience working with external diagnostic partners and precision medicine strategy development.
What We Offer:
  • Competitive salary range: $149,000 - $234,300.
  • Opportunities for professional growth and development.
  • A dynamic and collaborative work environment.
  • A comprehensive benefits package, including medical, dental, vision insurance, 401(k) plan, and company match.

Takeda is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating a diverse and inclusive workplace that reflects the communities we serve.



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