- Daiichi Sankyo, Inc. (Bernards, NJ)
- …this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support of multiple projects within Daiichi Sankyo's ... to the FDA and other health authorities globally.At least 4 years of companion diagnostic development experience within a pharmaceutical company.At least 2 years… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …key scientific questions and steps taken to answer them.- With the Companion Diagnostics group, develop a companion diagnostic plan for the program ... In addition, he or she will interact with counterparts in the Companion Diagnostics group to support the program. Other responsibilities will include but not… more
- Danaher Corporation (Deer Park, IL)
- …is responsible for regulatory strategy development and execution for high-complexity diagnostics specifically Companion Diagnostics and digital pathology ... matters when it comes to cancer. You'll help develop diagnostic solutions that turn anxiety into answers and aid...working knowledge of FDA and EU regulatory requirements for Companion Diagnostics (CDx) devices. Further regions are… more
- Amgen (Washington, DC)
- …and / or in vitro diagnostics development + Experience in companion diagnostics development and knowledge of regulatory submission requirements of in ... transform the lives of patients while transforming your career. ** Senior Principal Scientist - Global Diagnostic Development...the company. This position will report to a Global Diagnostics Strategy Director and be responsible for… more
- GRAIL (Menlo Park, CA)
- …and to support Grail's partnerships with pharmaceutical companies for companion diagnostic (CDx) tests. The Associate Director , Clinical Compliance will play ... System (CQMS) and advancing clinical compliance oversight across clinical studies and companion diagnostic (CDx) development. In this highly visible role, you'll… more
- Bristol Myers Squibb (Princeton, NJ)
- …+ Biomarker & CDx Strategy: Extensive experience in designing regulatory strategies for companion diagnostics and biomarkers, with deep expertise in assay and ... member of the Translational Medicine CLIA Laboratory Steering Committee, the director drives coordinated early-stage drug- diagnostic strategies and health… more
- CSL Behring (King Of Prussia, PA)
- …encompasses complex medical devices with clinical development, software as a medical device and companion diagnostics )? The job is in our King of Prussia, PA or ... onsite three days a week. You will report to the Executive Director Head Regulatory. **Position Description** **Summary** *Regulatory leaders who develop a global,… more
- Taiho Oncology (Pleasanton, CA)
- …strategic thinking to develop clinical development plans (incl. study design and companion diagnostics ) + Take accountability for strategy and deliverables of ... assessments for the study conduct and operational risks. Represent the molecule at senior management governance meetings. + Mentoring and training of junior staff in… more
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