- BeOne Medicines (Emeryville, CA)
- …and amendments + Informed consent documents + Investigator Brochures + Clinical study reports + Abstracts, posters and manuscripts + Clinical sections of INDs ... Update Reports + Clinical sections of Health Authority Briefing Documents, Orphan Drug applications, and annual reports + Risks / benefits analysis for applicable… more
- Merck (South San Francisco, CA)
- …experience. DPS is a multi-disciplinary research group that provides drug delivery, solid state crystal form characterization, formulation support and ... small molecule and biologics developability assessments at the development and drug discovery interface. Our team is responsible for the characterization of… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …Analytical Development** + Lead and oversee phase appropriate method development and optimization for drug substance and drug product at CDMOs + Design and lead ... method validation and implementation activities for drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and… more
- Veterans Affairs, Veterans Health Administration (Fresno, CA)
- …stricture dilation, EGD with Peg, colonoscopies, push enteroscopy, GI manometry, Bravo study , advance imaging studies like NBI and chromoendoscopy. The physician ... position are subject to urinalysis to screen for illegal drug use prior to appointment. Applicants who refuse to...Affairs for the year in which the course of study was completed. Current, full and unrestricted license to… more
- Amgen (Thousand Oaks, CA)
- …scientific strategy and planning and execution for all aspects of clinical drug development across Amgen's clinical programs. This Executive Director within Clinical ... with the full scope of the rare disease clinical drug development activities from the design and execution of...design and execution of Phase 2 through Phase 4 studies . They will serve as the principal representative for… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …**pharmacometrics** studies , while providing input into all phases of drug development including, but not limited to dose finding, dose optimization, ... phase assets. **Job Description** + Conduct **pharmacometrics** activities related to study design, protocol development, study execution, reporting and… more
- Kelly Services (Petaluma, CA)
- …bringing innovative antimicrobial solutions to market. The company combines device and drug expertise, operates under strict FDA regulations, and is scaling up for ... Responsibilities** + Collaborate with engineering teams to design and execute clinical studies that validate device performance. + Manage Class II and Class III… more
- Lilly (San Diego, CA)
- …Development Excellence** + In collaboration with stakeholders, design early clinical studies that efficiently test therapeutic hypotheses + Collaborate with clinical ... biostatistics, regulatory affairs, operations, and other stakeholders to optimize study design and execution + Integrate translational endpoints and biomarker… more
- AbbVie (South San Francisco, CA)
- …to agreed-upon timelines. Identify and anticipate issues arising in the study design, conduct and propose scientifically sound approaches. Evaluate appropriateness ... develop scientifically appropriate strategies for evidence generation, including GMA studies , presentations, and publications in assigned therapeutic area(s). Support… more
- AbbVie (South San Francisco, CA)
- …function/department on project team(s) to provide statistical input to compound/ drug development and drive alignment with functional management. Partner with ... Propose novel statistical methodological approaches to design of scientific studies . Provide sufficient detail to allow programming implementation. Ensure that… more