Director of Diagnostic Sciences
2 weeks ago
About the Role
We are seeking a highly skilled and experienced Director, Diagnostic Sciences to join our Global Companion Diagnostics team at Daiichi Sankyo, Inc. This is an exciting opportunity to lead the end-to-end process for CDx implementation in clinical studies, ensuring that sample testing and data generation activities are completed in alignment with the therapeutic and diagnostic team needs.
Key Responsibilities
- Design and lead clinical trial sample testing activities and data capture to support CDx regulatory submission or associated drug regulatory submissions
- Responsible for implementation of clinical trial assays at Diagnostics Partners, reference labs, and specialty testing vendors
- Develop and implement a testing quality monitoring program, ensuring consistent data monitoring and output across the asset portfolio, and aligned CDx partners
- Support development of Dx product portfolio under design and change control regulations (ISO 13485, ISO 20916, IVDD/IVDR, and QSR)
- Play a critical role in identifying and evaluating performance of new technologies in collaboration with Translational Science, building and maintaining relationships with external partners such as CROs, current and potential diagnostic co-development partners
Requirements
- MS/PhD/MD or PharmD in Life Sciences required
- At least 5 years of diagnostic/assay development experience either within a pharmaceutical company, CRO, or a diagnostic company
- Demonstrated track record of success working on multidisciplinary pharmaceutical/biomarker/diagnostic development teams
- Broad knowledge and technical understanding of established and new assay technologies such as NGS, IHC, PCR
- Technical and operational understanding of the IVD Development Process and an understanding of how diagnostic development can shape drug development
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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