- Bristol Myers Squibb (Madison, NJ)
- …in order to gain their inputs on emerging science in drug and biomarker research, disease knowledge, and design of clinical development studies and programs + ... Maintains a strong medical/scientific reputation within the disease area. Has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder. Keeps up-to-date in the disease area by attending scientific conferences and ongoing review… more
- Charles River Laboratories (Mattawan, MI)
- …dose formulations, large and small molecule analysis, molecular and cell-based assays, Biomarker , and flow cytometry-based lab work. Staff participate in the review ... of methods; equipment records and the creation of report tables. Staff participate in the tracking and managing study related materials, providing requested data/information to the Project Scientist or Sponsor as required. Staff are knowledgeable in the… more
- J&J Family of Companies (Spring House, PA)
- …teams with data-driven recommendations, fostering innovation in target discovery, biomarker development, and compound optimization + Communicate findings through ... presentations, executive summaries and publications + Lead internal and external innovation partnerships **Qualifications / Requirements:** **Education:** + A minimum of a Bachelor's degree is required + Advanced degree (PhD) in Cell Biology, Molecular… more
- Pfizer (Cambridge, MA)
- …appropriate combinations, as well as evaluation of potential predictive and pharmacodynamics biomarker plans. + To ensure the clinical components of the clinical ... plans and clinical expertise are provided to project teams, including medical monitoring of clinical trials. + To support projects from Research to Proof of Concept at which point molecule may be handed to the late-stage Oncology Clinical Development team for… more
- Astellas Pharma (Northbrook, IL)
- …critical documents. + Able to assimilate Research, Clinical Pharmacology, Biomarker , medical safety, Toxicology (early phase programs) regulatory, biostatistics, ... medical affairs, Health Economics, commercial perspectives into clinical development strategies and trial designs. + Responsible for managing the process of development of protocol and necessary regulatory documents. + Accountable and responsible for… more
- Bristol Myers Squibb (Princeton, NJ)
- …cancer development and therapeutic resistance + Extensive knowledge of high-content biomarker platforms and good understanding of the current clinical practice in ... BrCa + Ability to work in a fast-paced environment with rapidly changing and competing priorities and ambiguity + Strong team player with the ability to work in cross-functional teams. Excellent communication and collaboration skills + Prior experience with… more
- Gilead Sciences, Inc. (Foster City, CA)
- …drug development + Early-stage development: IND-enabling studies, translational science, biomarker strategy, and early clinical trial design. + Regulatory knowledge: ... Familiarity with FDA/EMA guidance for preclinical and early clinical phases. + CMC awareness: Understanding of drug substance/product development and manufacturing timelines. + Possess strong business acumen to align drug development and launch strategies with… more
- Georgetown Univerisity (Washington, DC)
- …with FDA regulations and GCP guidelines. Other research areas include biomarker discovery, behavioral management, and diagnostic and assessment studies of dementia ... and related disorders. The NP supervises research staff and provides oversight to all trial related procedures. Additional responsibilities include engagement in community outreach and educational programs designed to inform the public regarding Alzheimer's… more
- Amgen (Washington, DC)
- …guidance to areas and teams in clinical development, clinical trial biomarker (CTA) and companion diagnostics (CDx) co-development, and precision Medicine ... organization. *Plan and execute statistical activities contributing to exploratory statistical analysis plans, reports and publications *Implement, manage and support standards, technical quality and consistent approaches in strategy, study design and… more
- Amgen (Washington, DC)
- …development, statistics and clinical operation leads to formulate appropriate imaging biomarker strategies. + Support central review and adjudication strategies led ... by imaging vendor + Serve as a SME while supporting imaging-focused strategic sourcing and vendor management teams in vendor capability/quality evaluations. + Provide subject matter expertise with regards to response criteria (RECIST, PCWG3, Lugano, RANO-BM… more
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