- BeiGene (San Mateo, CA)
- …study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional study team at internal ... quality, within agreed timelines and budget + Acts as regional lead for multiple studies across an...meetings and at the cross-functional Clinical Study Team (CST) meetings + Leads regional … more
- IQVIA (Berkeley, CA)
- …FUNCTIONS, DUTIES AND RESPONSIBILITIES: Responsible for all activities related to implementation of clinical studies including: * Manages projects of full scope ... responsible for all team members throughout the duration of each clinical trial. Assures clear client communication, process documentation, and compliance with… more
- Stanford University (Stanford, CA)
- … clinical investigators on relevant research methods. + Implement studies to address statistical issue arising from collaborations. **EDUCATION & EXPERIENCE ... Senior Biostatistician **School of Medicine, Stanford, California, United...of theQuantitative Sciences Unit (QSU)is to facilitate cutting-edge scientific studies initiated by Stanford investigators by providing expertise in… more
- BeiGene (San Mateo, CA)
- …+ Works cross-functionally to ensure proper planning of inclusive clinical study protocols, providing feasibility feedback on regional site selection and ... **General Description:** Reporting to the Head of Americas, Clinical Operations, the Director - Clinical ...to hold composure, be engaged and present adeptly to senior BeiGene leadership when needed + Scientific acumen -… more
- BeiGene (San Mateo, CA)
- **General Description:** The Senior Manager of R&D Quality Systems, Strategy, and Excellence (Process & Procedure) is responsible for implementing and maintaining a ... implementation across teams. + Build strong partnerships across departments (eg, Clinical Operations, Regulatory Affairs, R&D) to ensure that quality is embedded… more
- Olympus Corporation of the Americas (San Francisco, CA)
- …methods needed to monitor external sources of information such as media reports and clinical studies that may require complaint investigation or MDR reporting. + ... than @Olympus.com, it is likely not legitimate._ **Job Description** The Manager, Senior Global MDR Submission is responsible for managing Market Quality- COE MDR… more
- Stanford Health Care (Palo Alto, CA)
- …of clinical results as appropriate; and present at local, regional and national research meetings/conferences as appropriate. + Reports on activities and ... which serves patients across the world. Its robust network of seven clinical sites staffed by Stanford's team of renowned surgical oncologists, medical oncologists,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Development organization, which includes responsibility for medical safety aspects of clinical studies such as protocol design, benefit-risk assessment, signal ... and leverage their experience to represent Patient Safety in discussions with senior leadership and Executive Management. The GHPS oversees patient safety governance… more
- BeiGene (San Mateo, CA)
- …including, but not limited to, global regulatory strategies, regulatory requirements for clinical studies and marketing approval in global markets, regulatory ... affairs departmental and cross-functional influence and acts as an advisor/liaison to senior management and project teams to plan, evaluate and recommend regulatory… more
- Gilead Sciences, Inc. (Foster City, CA)
- …a wide variety of documents of all types and complexities, such as clinical study reports (CSRs) (all phases), investigator's brochures, CTD summaries/overviews, ... timelines and resource planning for assigned projects. + May serve as a senior medical writer and department representative for a large development program or TA,… more
- BeiGene (San Mateo, CA)
- …but not limited to, North America regulatory strategies, regulatory requirements for clinical studies and marketing approval in the NA markets, regulatory ... the review of NA submission documents in support of clinical trials and marketing applications, and their amendments to...US and Canada. + Supports the NA solid tumor regional team to negotiate with the US FDA as… more
- BeiGene (San Mateo, CA)
- …but not limited to, North America regulatory strategies, regulatory requirements for clinical studies and marketing approval in the NA markets, regulatory ... the review of NA submission documents in support of clinical trials and marketing applications, and their amendments to...the US and Canada. + Supports the NA hematology regional team to negotiate with the US FDA as… more
- BeiGene (San Mateo, CA)
- …including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval in global markets, regulatory ... are met including the review global submission documents in support of clinical trials and marketing applications, and their amendments to support investigational… more
- Gilead Sciences, Inc. (Foster City, CA)
- …the world - Being Here Matters. We are seeking a bright and enthusiastic senior toxicologist to complement our Nonclinical Safety (ie Toxicology) group. Gilead is a ... multiple projects simultaneously with minimal supervision. + Reviews protocols, data and study reports ensuring presentation of data in report is accurate and… more