- Gilead Sciences, Inc. (Foster City, CA)
- …specializes in process improvements, procedural documents, and quality and inspection readiness for Clinical Operations . The Associate Director, will be a ... (CTC) organization offers infrastructure, support, and solutions enabling the Clinical Operations and Development Organizations with rapid, efficient,… more
- BeiGene (Emeryville, CA)
- …for design and delivery of early to late-stage medicines development across global clinical operations (GCO). Good understanding of global, regional, and country ... TA, indication, program levels + Partners with internal stakeholders including global clinical program leaders, global clinical study managers, development… more
- BeiGene (Emeryville, CA)
- …across an indication or across a program as required. + Leads the regional clinical operations team (including external partners working on a regional level) and ... Leadership** _Study management responsibilities:_ + Strategically leads the regional clinical operations team effectively across the department, ensures… more
- BeiGene (Emeryville, CA)
- The Associate Director (AD) Clinical Study Management leads both indirect and direct reports, external partners, consultants, vendors and external budget to ... synopsis, protocol, case report and informed consent forms, clinical study reports and investigator brochure. Leads...as IVRS selection, set-up, conduct, and close-out for BeiGene studies . + Adheres to Clinical Operations… more
- BeiGene (Emeryville, CA)
- …_Line management responsibilities:_ + Provides leadership, management, and/or mentorship to associate directors, clinical study managers at various ... the regional leadership team, provides strategic leadership, management, and/or mentorship to clinical study managers at various levels for assigned portfolio… more
- Abbott (Alameda, CA)
- …. This includes but not limited to planning and implementation of clinical studies from concept to clinical study report per timelines and quality ... levels with our new sensing technology. **The Opportunity** The Associate Clinical Research III will assist in...studies to management. + Ensures quality delivery of study deliverables within agreed budgets and timelines. + Participate… more
- BeiGene (Emeryville, CA)
- …colleagues in clinical development, program leadership, biometrics, clinical operations , safety/pharmacovigilance, regulatory, molecular diagnostics, and ... existing skills to oncology. + Expert understanding of global clinical study design and drug development process...documents. Clinical Development Plans + Partner with clinical operations and other functional areas for… more
- BeiGene (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 ... regulations, and applicable SOPs. The SCRA collaborates with the Clinical Study Teams (CSTs) by supporting day...regulatory guidelines * Minimum of 4-6 years of relevant Clinical Operations experience * Minimum of 3-4… more
- Kelly Services (Alameda, CA)
- ** Associate Clinical Supplies Director** Think the best job opportunities are far away? Think again. Great opportunities are right here in your backyard. ... Science & Clinical is looking for an ** Associate Clinical Supplies Director** to work at...supply strategies and collaborating with various teams like Pharmaceutical Operations , Clinical Operations , Regulatory Affairs,… more
- Abbott (Alameda, CA)
- … manages the design, execution, and monitoring of internal and external clinical studies , coordinates the development of operating procedures, coordinates in ... products **What you'll work on** + Manage design, execution, and monitoring of internal clinical studies , including management of budget + Manage in the design,… more
- AbbVie (South San Francisco, CA)
- …pertaining to safety and efficacy of the molecule. Along with Clinical Operations , may be responsible for oversight of study enrollment and overall timelines ... and evaluate business development opportunities. + Responsible for providing focused scientific and clinical study support from start-up clinical study … more
- AbbVie (San Francisco, CA)
- …and AbbVie study staff. * Has overall responsibility for oversight of clinical studies , monitoring overall study integrity and review, interpretation and ... efficacy of the molecule. Along with Clinical Operations , is responsible for oversight of study ...Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and… more
- Pfizer (South San Francisco, CA)
- **ROLE SUMMARY** + Design, analyze, and interpret clinical trials and/or observational studies in compliance with relevant regulatory requirements, Pfizer ... and leadership to cross-functional activities, in collaboration with other statisticians, study managers, and programming colleagues, for assigned studies or… more
- AbbVie (South San Francisco, CA)
- …meet required timelines, budgets, and regulatory requirements. May directly manage key clinical projects within PMed. - Manage biomarker operations and logistics ... implement translational strategies to advance AbbVie's innovative Oncology pipeline. The Associate Director, Biomarker Program Management, leads a team within the… more
- BeiGene (Emeryville, CA)
- …data pipelines to support transformation initiatives in investigator payment management and clinical operations . + Develop and maintain ETL processes to ensure ... lifecycle. + Assist in the development and optimization of clinical site budgets, ensuring alignment with study ...and maintenance of data models and databases to support clinical operations and financial processes. + Support… more
- AbbVie (South San Francisco, CA)
- …in a well-supported and dynamic environment to help advance novel therapeutics into pre- clinical and clinical studies . Responsibilities: + Develop cell ... develop novel biotherapeutics. Job Description We are seeking an Associate Scientist II or Scientist I to join a...and collaborative team to develop cell culture processes for pre- clinical and clinical manufacture. In this position,… more
- BeiGene (Emeryville, CA)
- …be working collaboratively with R&D Quality leadership and cross-functional partners (IT, Clinical Operations , Data Management, RBQM, and Global Quality.) This ... **General Description:** The Associate Director R&D Quality Excellence, Analytics, and Innovation...**Significant Contacts** + Quality + Global Technical Solutions + Clinical Operations + Data Management + Risk… more
- Bristol Myers Squibb (Brisbane, CA)
- …late stage TM group. The individual will be responsible for TM and clinical biomarker activities to support drug development programs in multiple diseases in ... assume biomarker lead responsibilities, such as serving as biomarker representative on study teams, setting up biomarker plans for individual trials and ensuring… more
- AbbVie (South San Francisco, CA)
- …and AbbVie study staff. + Has overall responsibility for oversight of clinical studies , monitoring overall study integrity, and review, interpretation, ... efficacy of the molecule. Along with Clinical Operations , is responsible for oversight of study ...Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and… more
- Bristol Myers Squibb (Brisbane, CA)
- …biomarker leads and appropriate stakeholders of documents which may support the final clinical study report in relevant SharePoint sites and/or repositories + ... development, outsourcing, vendor management, biospecimen, data management, biostatistics, and operations teams to align with ICN and strategic stakeholder priorities… more