- BeOne Medicines (Emeryville, CA)
- …and safety section for clinical data management plan for capture during clinical trials , supports the review and update of data management plan based ... The Executive Medical Director serves as the Lead Product Safety Physician...of safety data required for capture in CRFs during clinical trials , reviews and provides product program… more
- Bristol Myers Squibb (San Diego, CA)
- …+ Prior experience interpreting and implementing regulations and guidelines governing clinical trials + Advanced computer and Internet skills, including ... to be the global leader in radiopharmaceuticals . The Director , Medical Affairs Research Operations, plays an integral role...perspectives in a supportive culture, promoting global participation in clinical trials , while our shared values of… more
- AbbVie (San Francisco, CA)
- …+ Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in the design of protocols. May have ... (MI) materials. + Participates in design and execution of clinical trial safety, product safety and risk...hematology experience preferred. + Minimum of 4 years of clinical trials direct management experience in the… more
- Bristol Myers Squibb (Brisbane, CA)
- …developing clinical trial protocols and/or enrolling patients in clinical trials . -Expertise in the early and/or late development space, relevant ... an MD with clinical experience and academic and/or industry experience leading clinical trials . -Passion for evolving science and desire to identify and… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …Global Quality will ensure OAPI, OPDC and all affiliates are inspection ready, oversee clinical trial and submission support, lead the R&D audit program, engage ... Responsibilities:** + **Inspection Readiness:** Ensure continuous inspection readiness across all clinical trial sites, clinical and Pharmacovigilance (PV)… more
- Sumitomo Pharma (Sacramento, CA)
- …and Product Complaints (PCs) + Contributes to medical safety of clinical trials , including monitoring of clinical trial safety and laboratory data. ... marketed products. + Conduct safety surveillance over product life cycle, reviewing clinical trial and post-marketing Individual Case Safety Reports (ICSRs),… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …required + Develop and manage the Medical Affairs to ensure effective and compliant clinical products and clinical trials to support regulatory and ... bodies + Provide subject matter expertise into design of clinical trials for medical device development and...ICCS, NCCN, ASCO, WHO, etc.) + Prior experience in clinical trial design, operations and execution +… more
- BeOne Medicines (Emeryville, CA)
- …for manuscripts / presentations and provides statistical support in designing and analyzing clinical trials , and in coordinating the statistical activities for ... procedures, and external regulatory requirements. + Analyzes data and interprets results from clinical trials to meet objectives of the study protocol. Applies… more
- Pfizer (South San Francisco, CA)
- + **ROLE SUMMARY** + Support clinical trials and the development strategy for early development assets and lead development programs with a focus on multiple ... development plan from pre-IND stage to first in human clinical trial to proof-of-concept, including assessment of...are provided to project teams, including medical monitoring of clinical trials . + To support projects from… more
- Gilead Sciences, Inc. (Foster City, CA)
- …within Inflammation Therapeutic Area (TA), and oversee all biostatistics workstreams for clinical trials , assets evaluations, and regulatory submissions in the ... all departmental standards and processes regarding the conduct of clinical trials , statistical methodology, data analysis and...In depth knowledge of and strong advocate for Good Clinical Trial Practices, ICH, and regulatory guidance.… more
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