- AbbVie (Irvine, CA)
- …drug substance and drug product development. + Experience developing global regulatory strategies including authoring regulatory submissions, and responding to ... position involves multi-disciplinary collaborations across Discovery, Development, Manufacturing, and Regulatory to execute and deliver material and information for… more
- Gilead Sciences, Inc. (Foster City, CA)
- …objectives and disease area strategies. To this end, experience in the analysis early and late stage clinical trials with multi-dimensional human data sets ... protocols and associated documents as well as participate in meetings with regulatory authorities. In addition, the scientist will direct the implementation of… more
- Amazon (Los Gatos, CA)
- …join us in shaping the future of the connected home. As Manager of Regulatory Compliance, Safety, and RF Validation Engineering, you will lead a team of individual ... and ensuring eero's product portfolio meets internal specifications and regulatory compliance. This role combines strategic leadership with hands-on technical… more
- General Atomics (San Diego, CA)
- …practical support solutions to technical engineering problems in reactor fuel cycle analysis and safety design and operation to support startup, full power ... support to other staff members working on engineering analyses for thermal/fluids analysis , nuclear systems evaluations and core/assembly analysis . + Supports… more
- BeOne Medicines (San Mateo, CA)
- …ideal candidate will have a strong background in research, clinical development, regulatory affairs, and safety, with a particular focus on process excellence and ... R&D department** , aligning technology initiatives with research, clinical development, regulatory , and safety goals. + **Drive innovation in research** by… more
- Sumitomo Pharma (Sacramento, CA)
- …with the clinical team on the statistical design of the studies, and the analysis and data presentations for the studies. **Job Duties and Responsibilities** + Serve ... statistical design, authoring statistical sections of study protocols and Statistical Analysis Plans (SAPs), and supporting trial design, including sample size… more
- BeOne Medicines (San Carlos, CA)
- …Director, Pipeline Analytics to drive data-driven insights into pipeline molecule analysis , R&D investment optimization, and portfolio prioritization. This role is ... quantitative assessments of pipeline molecules, integrating clinical, commercial, and regulatory factors to evaluate potential success. + Develop predictive models… more
- Merck (San Francisco, CA)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... pharmacokinetics (popPK), PK/PD models, exposure response (ER) models, model-based meta- analysis (MBMA), clinical trial simulations (CTS) and disease progression… more
- BeOne Medicines (Emeryville, CA)
- … Affairs, and Clinical Development to ensure robust study design, insightful data analysis , and timely support for global regulatory submissions. Deep expertise ... in PK modeling, including non-compartmental and population PK analysis , and experience with regulatory interactions are essential. Experience in relevant disease… more
- Teledyne (San Diego, CA)
- …VP of Engineering at Teledyne API. We are seeking a highly skilled and motivated PhD -level Engineer or Scientist to join our team as a domain expert in real-time ... goals and customer needs. + Maintain direct contacts at regulatory agencies in the US and around the globe,...seamless integration of engineering solutions. + Guide root cause analysis and implement corrective actions for field issues and… more