- Pfizer (San Diego County, CA)
- …operational expertise to Study Teams to ensure delivery of high-quality clinical biomarker data. + Lead novel assay development and timely availability ... and external continuous improvement efforts. + Maintain up-to-date knowledge of biomarker assay technologies and clinical laboratory standards,… more
- Pfizer (New Haven, CT)
- …PCRU Quality Manager, PCRU Documentation Specialist, PCRU Data Manager, (external) Pfizer Clinical Assay Lead **PHYSICAL/MENTAL REQUIREMENTS** Must be able ... lab space + Support green lab initiatives Conduct all biomarker assay validations and clinical ...and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's… more
- Amgen (Thousand Oaks, CA)
- …best work alongside other innovative, driven professionals in this meaningful role. ** Clinical Biomarker and Diagnostics Operations Lead ** **Live** **What ... tracking biomarker deliverables. + Drives the implementation and execution of the clinical biomarker and diagnostic plans for programs in early and late… more
- Takeda Pharmaceuticals (Boston, MA)
- …that will inspire you and empower you to shine? Join us as a BST and Clinical Biomarker Lead , Neuroscience, Associate Director in our Cambridge, MA location. ... BST Lead will also oversee implementation of biomarker and bioanalytical strategies in clinical trials... assay development and validation activities, and high-quality biomarker and bioanalytical data delivery to clinical … more
- Takeda Pharmaceuticals (Boston, MA)
- …for innovation and early discovery, non- clinical development, translational & biomarker research and bioanalytical assay development to support nonclinical- ... and/or collaboratively conducts PK and PK/PD analyses during late stage lead optimization through early pre- clinical development and collaborates in… more
- Bristol Myers Squibb (Princeton, NJ)
- …not limited to responsibility for genomics and gene expression profiling (GEP) biomarker assay technology/ platform selection, evaluation of in-house or vendor ... is a must. + The candidate must demonstrate significant work experience in clinical assay development for genomics assets preferably in a pharma, biotech,… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …role, they will design, develop, communicate across levels and operationally implement clinical biomarker strategies to support select programs in early and ... late stage drug development. Clinical biomarker assays include pharmacokinetic assays, patient...cross-disciplinary teams in pharmaceutical or biotech industry. Experience in clinical assay development, validation and implementation with… more
- Bristol Myers Squibb (Summit, NJ)
- …and vendors for clinical biomarkers, and manages outsourcing of biomarker assay development and validation partnering with Translational Sciences colleagues ... group. The individual will be responsible for TM and clinical biomarker activities to support drug development...neuropsychiatry. This individual will have the opportunity to assume biomarker lead responsibilities, such as serving as… more
- Bristol Myers Squibb (Cambridge, MA)
- …and vendors for clinical biomarkers, and manages outsourcing of biomarker assay development and validation partnering with Translational Sciences colleagues ... late stage TM group. The individual will be responsible for TM and clinical biomarker activities to support drug development programs in neurodegeneration and… more
- Astellas Pharma (Cambridge, MA)
- …in the identification and validation of pharmacodynamic and patient selection biomarkers, biomarker assay qualification and clinical implementation. + ... POC. + A strong track record in delivering high quality translational science and clinical biomarker data to inform decisions and development strategy. + Broad… more
- Lilly (Indianapolis, IN)
- …to immunogenicity and biomarkers. + Ability to investigate new innovative clinical biomarker and immunogenicity analytical technologies + Familiarity with ... will be on the implementation of immunogenicity and related biomarker assays to support the clinical portfolio....support to LEM, CLO, and the study team. + Lead the trouble-shooting efforts regarding scientific assay … more
- Bristol Myers Squibb (Seattle, WA)
- …Cellular Therapy Thematic Research Center. The candidate will collaborate closely with the Biomarker Lead to establish assays in alignment with the program's ... implementation plan of assays to address key translational questions in early phase clinical trials + Provide technical guidance on assay selection, design,… more
- Eurofins (Lenexa, KS)
- …testing, our newest product for liver transplant patients is a blood-based biomarker assay designed to rule out rejection as immunosuppression therapy ... discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract… more
- Takeda Pharmaceuticals (Boston, MA)
- …Business Unit (Commercial and Medical Affairs), Alliance Management, Business Development, and clinical biomarker technologies. The level of the position will be ... you to shine? Join us as a Companion Diagnostic Lead in our Cambridge office. At Takeda, we are...follow-on and region-specific workstreams + Drive technical assessment of assay /device analytical and clinical validation + Identify… more
- Bristol Myers Squibb (Summit, NJ)
- …Drive the execution of program and portfolio strategy reviews, in partnership with Biomarker Operations and the Translational Medicine Lead , using scientific and ... manage multiple complex high-profile portfolio assets and facilitate broad, integrated biomarker plans to enable the delivery of our translational medicine… more
- Pfizer (New York, NY)
- …including in depth knowledge of biomarker -based indication selection, assay development, analytical validation, clinical validation and commercial launch ... development programs. The successful candidate must possess a deep understanding of clinical biomarker development, the commercial testing landscape, and the… more
- Bristol Myers Squibb (Seattle, WA)
- …researcher responsible for driving and implementing translational development strategies and clinical biomarker plans for BMS cellular therapy clinical ... and interpret translationally focused experiments and analyses. Activities include biomarker identification, collaboration on assay validation and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …scientific and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads ... this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support...the CDx portfolio leader, covering all areas from CDx assay development through CDx approval and launch. May act… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Team. In addition, he or she will interact with the Companion Diagnostics Lead , Non- Clinical Research, Medical Affairs and other stakeholders to support the ... and plan. Align closely with the Senior Translational Strategy Lead . + Construct translational plan documents, biomarker ...disease biology and drug mechanism of action, aligned with clinical development. + Deep knowledge in biomarker … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …drug development. + Expertise in companion diagnostics development and implementation of biomarker assays in support of multi-site global clinical trials is ... be responsible for end-to-end process for CDx Implementation in clinical studies. They will ensure that sample testing and...of Dx devices under design control process. They will lead identification and selection of Dx assays and partners… more