- BeOne Medicines (San Mateo, CA)
- **General Description:** This position will be responsible for the management of clinical outsourcing needs in support of BeOne's current and planned clinical ... vendor oversight/governance. This position will also be responsible for clinical study budget estimation and budget management during the...level. **Essential Functions of the job:** + Manages the clinical studies at study and program level as the… more
- Pfizer (South San Francisco, CA)
- …states to optimize doses, dosage regimens and study designs throughout clinical drug development. + Identifies opportunities where modeling and simulation can ... provide MIDD expertise on multidisciplinary development teams, working closely with clinical pharmacologists, clinicians, and statisticians to create MIDD plans that… more
- GRAIL (Menlo Park, CA)
- …and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome ... + **Experience** + Minimum of 10 years of experience in regulatory, development, clinical affairs, quality, or program management within the IVD, medical device, or… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** + Provide project/program management support on clinical development project teams. + Develop, validate and maintain project schedules ... Qualifications:** + Bachelor's Degree with 8 + years' experience in clinical and drug development in the biotech/pharmaceutical industry OR Master's Degree… more
- AbbVie (Irvine, CA)
- …core team meetings involving Tissue Management Science, Product Development, Clinical , Medical Affairs, Quality, Regulatory, Health Economics Outcomes Research, ... prioritization of multiple product features and attributes. + Understands and supports clinical studies to optimize promotional and economic claims. + Develops close… more
- Cedars-Sinai (Los Angeles, CA)
- …and Gynecology as the leader of the Division of Gynecologic Oncology at the Associate or Professor level. Cedars-Sinai gynecology was recently ranked number 7 in the ... both clinically and academically, with a very busy surgical schedule, sizeable clinical trials portfolio as well as cutting edge translational research. Outpatients… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …processing (NLP) to extract insights from unstructured medical texts, such as clinical notes or call center transcripts. + Identifying relevant data drivers ... (features) that can inform decision making closely tied with strategy and creating visualizations to help communicate findings. **Advanced Analytics & Modeling** + Implement advanced analytics models, including predictive analytics and clustering algorithms,… more
- BeOne Medicines (San Mateo, CA)
- …+ Experience working with Life Sciences data, including exposure to R&D, Clinical Operations, TechOps, or Manufacturing domains. Understanding of key systems (CTMS, ... EDC, eTMF, LIMS, MES, PV systems), data models (CDISC, SDTM, ADaM), and typical data challenges (quality, lineage, integration, governance) is highly desirable **Supervisory Responsibilities:** No All qualified applicants will receive consideration for… more
- AbbVie (Irvine, CA)
- …go-to-Dev/Feasibility/Launch, as well as prioritization of R&D investment in new clinical programs + Understand and utilize market research and business intelligence ... to discover and quantify financial impacts of marketing sizing and competitive events + Manages operational aspects of the forecasting process including coordination of appropriate forecast inputs, reviews, alignment discussions, and data submissions +… more
- BeOne Medicines (San Mateo, CA)
- …lifecycle for the assigned project. + Provide CMC regulatory review for clinical protocols and investigator brochures, etc. for the assigned project. + Provide ... comments on new global guidance through company's commenting process. **Supervisory Responsibilities:** The position may or may not manage direct report(s). **Computer Skills:** Microsoft 360, Familiarity with Veeva is a plus. **Qualifications:** + 8+ years of… more