- Takeda Pharmaceuticals (Boston, MA)
- …Program Team. + Provide operational support in the development and execution of companion diagnostic strategy including program level deliverables (clinical ... Oncology Drug Discovery and Regulatory Sciences to successfully deliver, communicate and execute companion diagnostic strategy for projects and platforms. +… more
- Astellas Pharma (Northbrook, IL)
- … Diagnostics team is dedicated to the co-development of companion diagnostics and the implementation of diagnostic testing for patient selection and ... studies across all phases of drug development. As a Diagnostic Regulatory Strategy Lead, you will be...diagnostic regulatory pathways for drug clinical studies and companion diagnostics . + Experience working in pharma… more
- J&J Family of Companies (Raritan, NJ)
- …sector) Global Regulatory Affairs (GRA) organization and will support in vitro diagnostics Regulatory Affairs, including companion diagnostics , in support ... requirements globally. + Monitor current and pending approvals in specific therapeutic/ companion diagnostic /medical device areas and be knowledgeable of laws,… 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
- Roche (Indianapolis, IN)
- …Roche's current and future diagnostic portfolios. The work of the Scientific Strategy Director is done in close collaboration with the global research and ... to come. Join Roche, where every voice matters. **The Position** **Scientific Strategy Director (Oncology - Pathology, Sequencing)** **The Opportunity:** The… more
- Amgen (Washington, DC)
- …both within and outside the company. This position will report to a Global Diagnostics Strategy Director and be responsible for the successful implementation ... the successful transition of a biomarker assay to marketed Diagnostic to support the clinical development strategy ...in vitro diagnostics development + Experience in companion diagnostics development and knowledge of regulatory… 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 **Summary / Scope** At Bristol Myers Squibb,… more
- Merck (Rahway, NJ)
- …Business Development, Business Operations, Business Opportunities, Clinical Diagnostics , Companion Diagnostics (CDx), Development Strategy , ... precision medicine needs including new biomarker technologies, digital pathology, and companion diagnostics in oncology and other therapeutic areas. **Primary… more
- Bristol Myers Squibb (Princeton, NJ)
- …& CDx Strategy : Extensive experience in designing regulatory strategies for companion diagnostics and biomarkers, with deep expertise in assay and IVD ... Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy for biomarkers and diagnostics , focusing on early-stage development… more
- Bristol Myers Squibb (San Diego, CA)
- …+ Prior experience in development programs with radiopharmaceuticals, theranostics and/or companion diagnostics highly desirable **Skills and Qualifications** + ... in their personal lives. Read more: careers.bms.com/working-with-us . **Summary** The Director , Clinical Program Management, reporting to the Head of Clinical… more