United States Job Openings
Pfizer
Senior Manager, Companion Diagnostics
Bothell
FULL TIME
August 28, 2024
- Design clear strategic recommendations for incorporating clinical testing and companion diagnostic development into patient selection trials incorporating scientific, regulatory, commercial and global considerations
- Provide oversight of the integration of clinical assays or IVDs into clinical trials including reviewing sections of clinical protocols, lab manuals and/or ICFs.
- Provide regulatory expertise to all programs, author key sections of regulatory documents and represent Seagen at regulatory interactions.
- Collaborate with the Clinical Development Operations, Regulatory and Commercial functions to drive diagnostic and clinical testing strategy from IND to Launch.
- Candidates must have a Ph.D or MD with proven experience developing approved companion diagnostics
- Demonstrated experience in the development of companion diagnostic and biomarker strategies, including in depth knowledge of biomarker-based indication selection, assay development, analytical validation, clinical validation and commercial launch of companion diagnostics in oncology
- Broad understanding of clinical development processes and regulatory approval processes of companion diagnostics
- Expertise in commercial implementation of assay methodologies such as PCR and NGS.
- Experience with communicating precision-medicine strategy, issues, and risks in written and verbal format to company senior leadership team and other governing bodies.
- Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
- Excellent communication, analytical and organizational skills.
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