- CSL Behring (Waltham, MA)
- …developing therapies that make a meaningful difference worldwide. Could you be our next Senior Manager Regional Regulatory Lead, Vaccines? The job is in our ... and/or Device/EHT related development teams, including critical partners, in research , clinical development, commercial development, business development,… more
- Children's Hospital Los Angeles (Los Angeles, CA)
- …experiences, perspectives and backgrounds allow us to better serve our patients and create a strong community at CHLA. Clinical Research Regulatory Affairs ... Matters.** **Overview** **Purpose Statement/Position Summary:** The Clinical Research Training Specialist Sr serves as a senior... Research Training Specialist Sr serves as a senior -level contributor within the Clinical Research… more
- GRAIL (Menlo Park, CA)
- …+ Thorough knowledge of GCP, ICH guidelines and other US and international clinical regulatory requirements + Working experience with an electronic data capture ... and monitoring compliance with study protocols, plans, SOPs, GCP/ICH, and all applicable regulatory requirements. + Manages all clinical operational aspects of a… more
- BeOne Medicines (Emeryville, CA)
- …program leadership, biometrics, clinical operations, safety/pharmacovigilance, regulatory , molecular diagnostics, and translational research . **Essential ... The Senior Director, Clinical Development, Solid Tumors...play a key role the establishment and growth of Clinical Research functions to assure best-in-class global… more
- Formation Bio (New York, NY)
- …pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines ... GXP, Data Integrity, and CSV activities across various entities, investigator sites, research organizations, clinical and nonclinical studies, PV vendors, and… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …strategy from early research through IND-enabling studies and into clinical development, ensuring regulatory compliance and scientific rigor in support ... scientific and strategic input to project teams across discovery, preclinical, regulatory , and clinical functions.Manage non-GLP and GLP-compliant studies… more
- Merck & Co. (San Diego, CA)
- …and partnering necessary for pharmaceutical development with Translational Medicine, Clinical , CMC, Regulatory , Operations, and other functional areas.Effective ... leader with deep expertise in Immunology Discovery and Translational Research to join our vibrant Research &...design and execution of translational data generation from internal clinical studies. The individual will also play an important… more
- Carnegie Mellon University (Pittsburgh, PA)
- …play a central role in coordinating these studies, analyzing outcomes, and preparing regulatory documentation in collaboration with clinical and regulatory ... bioengineering, bioprinting, or bioreactor development. + Demonstrated success in leading or senior roles in collaborative research projects. + Experience in… more
- Novo Nordisk Inc. (Boulder, CO)
- …Watertown, Cambridge and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for ... About the Department Our Research & Development organization brings together the best...such as Quality Assurance/ Control, Chemical Development, Program Management, Regulatory , Analytical Development, Materials Management, and Clinical … more
- Merck & Co. (Rahway, NJ)
- …our Device Development & Technology (DD&T) organization to serve as a senior technical subject matter-expert and advisor for our Autoinjector platform. This role's ... medical device engineering, particularly in the design, manufacturing, and regulatory aspects of Autoinjectors and combination products.Primary Responsibilities:Technical Strategic… more
