- 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 ... potential CDx assays. Leads CDx project teams for the diagnostic , in full alignment with Global Project...and other health authorities globally.At least 4 years of companion diagnostic development experience within a pharmaceutical… 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 ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...he or she will interact with counterparts in the Companion Diagnostics group to support the program.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the continuum of preclinical and clinical stages preferred.- Experience/knowledge in companion diagnostics device development preferred- Demonstrated ability to ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Genmab (NJ)
- …trial designsExperience with drug development in biologics, targeted therapies, and companion diagnostics preferredExperience working with FDA, EMA, and ICH ... diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and...we would love to have you join us!Role:The Associate Director acts as a statistical expert supporting the clinical… more
- Bristol Myers Squibb (Cambridge, MA)
- …more: careers.bms.com/working-with-us . **Key Responsibilities:** In the role as Associate Director , Companion Diagnostics Program Management within ... late, and lifecycle) + Manage the implementation of Biomarker Strategies and Companion Diagnostic projects to support global Development Teams + Responsible… more
- Danaher Corporation (Deer Park, IL)
- …is responsible for regulatory strategy development and execution for high-complexity diagnostics specifically Companion Diagnostics and digital pathology ... Director , Regulatory Affairs and is part of the Global Regulatory Affairs and will be fully remote. In...working knowledge of FDA and EU regulatory requirements for Companion Diagnostics (CDx) devices. Further regions are… more
- Regeneron Pharmaceuticals (Warren, NJ)
- …will be accountable for defining and supporting the implementation of our Companion Diagnostics and Clinical Lab strategies. Your responsibilities will include ... and complex contracts/contracting, supplier management activities, and engagement activities across Companion diagnostic partners. * Drives value in terms of… more
- Amgen (Washington, DC)
- …areas both within and outside the company. This position will report to a Global Diagnostics Strategy Director and be responsible for the successful ... the lives of patients while transforming your career. **Senior Principal Scientist - Global Diagnostic Development Lead** **What you will do** Let's do this.… 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 ... continuously refine the organization's inspection readiness framework for clinical studies and companion diagnostic development, spanning global and regional… more
- CSL Behring (King Of Prussia, PA)
- …make a meaningful difference worldwide. Could you be our next Associate Director Global Regulatory Lead, EHT (Enabling Healthcare Technologies encompasses ... with clinical development, software as a medical device and companion diagnostics )? The job is in our...days a week. You will report to the Executive Director Head Regulatory. **Position Description** **Summary** *Regulatory leaders who… more
- Bristol Myers Squibb (Princeton, NJ)
- …The Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy for biomarkers and diagnostics , focusing on early-stage ... Competency Requirements** + Scientific & Diagnostic Expertise: Deep expertise in global diagnostic development-including, but not limited to key markets such… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work ... determined to make life better for people around the world. **Associate Director - Oncology - Clinical Laboratory Sciences** **Organization Overview:** At Lilly, we… more
- Lilly (San Diego, CA)
- …tools, including developments in Precision Medicine, novel approaches or technologies, companion diagnostics , imaging techniques, etc. + Provide strategic input ... to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work… more
- Bristol Myers Squibb (Princeton, NJ)
- …II, Lab Planning & Operations will provide leadership and operational oversight for companion diagnostic (CDx) assay design, development, and clinical testing in ... & Translational Sciences (PMBATS) **Location** : Lawrenceville, NJ **Reports To** : Director , Lab Planning & Execution **Employee Grade** : EG-110 **Summary /… 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 ... onsite three days a week. You will report to the Executive Director Head Regulatory. **Position Description** **Summary** *Regulatory leaders who support development… more
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