- BeOne Medicines (Emeryville, CA)
- …of clinical study processes + Able to independently lead large and/or complex global clinical studies + 8 or more years of progressive experience in ... timelines and budget + Leads all aspects of assigned clinical study (ies) + Leads global ...endorsement by senior management + Adheres to clinical study budgeting processes and provides input… more
- BeOne Medicines (Emeryville, CA)
- …regular updates on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional study ... and budget + Acts as regional lead for multiple studies across an indication or across a program as...Clinical Study Report in collaboration with Global Clinical Study Manager and… more
- BeOne Medicines (Emeryville, CA)
- …clear potential to apply their existing skills to oncology. + Expert understanding of global clinical study design and drug development process from ... amendments + Informed consent documents + Investigator Brochures + Clinical study reports + Abstracts, posters and...functional areas for the successful implementation and execution of clinical studies . + Provide scientific expertise for… more
- BeOne Medicines (Emeryville, CA)
- …a site monitor and is responsible for the management and oversight of their assigned clinical study sites to ensure data quality and patient safety in accordance ... with ICH-GCP guidelines, local regulations, and applicable SOPs. The SCRA collaborates with the Clinical Study Teams (CSTs) by supporting day to day clinical … more
- Abbott (Alameda, CA)
- …have a deeper understand of the patients they are treating. **The Opportunity** This ** Senior Clinical Research Scientist** will work on-site at our Alameda, CA ... Abbott is a global healthcare leader that helps people live more...work closely within the New Medical Sensors medical and clinical study team including the medical director,… more
- BeOne Medicines (Emeryville, CA)
- …responsible to implement the GCO digital strategy with the goal to increase Global Clinical Operations' productivity and reduce clinical trial ... **General Description:** The Senior Manager, Digital Clinical Operations Solutions...Manage the implementation of GCO technology roadmap to increase Global Clinical Operations' productivity, reduce rising costs… more
- BeOne Medicines (Emeryville, CA)
- …Partners with internal stakeholders including global clinical program leaders, global clinical study managers, development core team etc.; combines ... studies , for early to late-stage medicines development across global clinical operations (GCO). Good understanding of...to accelerate study execution. + Partners with global clinical program leaders and development core… more
- IQVIA (Oakland, CA)
- … global ) Provide leadership and senior support to DTLs on multiple large global studies /programs of global studies Provide leadership and ... senior support to DTLs on multiple large global studies /programs of global ...Terminology, Pharmacology, Anatomy, and/or Physiology. IQVIA is a leading global provider of clinical research services, commercial… more
- BeOne Medicines (Emeryville, CA)
- …and present data to internal project teams, senior management, and to global health authorities. + Discuss clinical pharmacology & pharmacometric plans to ... all phases of clinical development. + Develop clinical pharmacology study designs and collaborate with...the design and analysis of PK data from patient clinical studies . + Conduct hands-on clinical… more
- BeOne Medicines (Emeryville, CA)
- …Plans), NDA/MAA (SCS/ISS, RMPs, initial Package Inserts) collaborating with PSLs and other Clinical Study Team (CST) members . Support the authoring of ... **_General Description:_** The Senior Manager, Safety Scientist supports assigned compounds in...making to execute these key deliverables in compliance with global regulations and internal processes. Effective communication and influence… more
- Abbott (Alameda, CA)
- …Presents project plans, provides ongoing updates, and presents project results to Division senior clinical management. + Assists in the management and execution ... Abbott is a global healthcare leader that helps people live more...clinical scientific support to project teams. + Evaluates clinical data in preparation of study summary… more
- BeOne Medicines (Emeryville, CA)
- …with responsibilities similar to those of a **Medical Science Liaison** . The ** Senior Field Medical Director (SFMD)** will support BeOne Medicines USA, Inc. Breast ... Cancer pre- clinical and clinical pipeline development by coordinating...across the organization. The candidate will report to the Senior Regional Director, Solid Tumor- Breast Cancer, within Medical… more
- BeOne Medicines (Emeryville, CA)
- …assessments and internal audits. + Drive the implementation of new processes with clinical quality, compliance, study teams, and cross-functional SMEs to ensure ... **General Description:** The Senior Director, Regulatory Affairs Strategy and Compliance is...and industry standards. ICH-E6 GCP, US FDA, EMA and Global regulations and guidance documents supporting clinical … more
- BeOne Medicines (Emeryville, CA)
- …limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval in global markets, regulatory strategic ... packages throughout the world and ensures timelines are met including the review global submission documents in support of clinical trials and marketing… more
- Charles River Laboratories (Emeryville, CA)
- …therapy development. Cell Solution's vertically integrated solutions support preclinical research, clinical studies from phases 1 to 3, and commercialization ... will make a difference every day. **Job Summary** The ** Senior Business Development Executive** is primary responsibility is to...River Cell Solutions** Charles River Cell Solutions is a global leader and trusted brand in the customization of… more
- Abbott (Alameda, CA)
- Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of ... AND DATABASE ACTIVITES - Works with project team to decide on appropriate study design and statistical methodology - Responsible for comprehensive protocol review -… more
- BeOne Medicines (Emeryville, CA)
- …Medical Affairs and Clinical Development. This role reports into the Senior Director of Global Scientific Communications and Publications in Solid Tumor ... **General** **Description:** The Solid Tumor Oncology Global Scientific Publications and Communications provides publications expertise and insight into the… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Senior Manager/Associate Director, HEOR position will lead and manage health economics and outcomes research (HEOR) and real-world ... policy-makers, or patients on the value propositions of our products. The Senior Manager/Associate Director will work closely with cross-functional teams and provide… more
- IQVIA (Oakland, CA)
- …to work with minimal supervision, using available resources, eg, functional managers, senior DTLs. + Comprehensive understanding of clinical drug development ... experience. + Previous experience and proven competence in managing study delivery through full DM life cycle (at least...with coworkers, managers and customers. IQVIA is a leading global provider of clinical research services, commercial… more
- BeOne Medicines (Emeryville, CA)
- …. The **Field Medical Director (FMD)** will support BeOne Medicines pre- clinical and clinical pipeline development by coordinating external collaborations, ... ensuring internal partnership across the organization. The candidate will report to the Senior Regional Director, Solid Tumor - GI, within Medical Affairs. As a… more