- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Degree required Experience:10 + years global clinical operations experience including organizational leadership and influencing senior -level management ... Excellence. Shape and implement a continuous process improvement framework for clinical operations ensuring quality and optimal delivery.Solicit GCO needs,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …aligned strategy.Responsibilities:Operational Strategy and Oversight:Align with the Senior Director, Global Clinical Operations on plans for successful ... following process and SOPs. The Director will ensure the Senior Director, Clinical Operations (Asset...This will include providing innovative strategies to continuously improve Global Clinical Operations quality and… more
- Eisai, Inc (Nutley, NJ)
- …(QAP) position is responsible for design, delivery and execution of the global Clinical Quality Assurance (CQA) strategy including audit and inspection ... potential. Essential Functions Direct and drive design, delivery, and execution of the global Clinical Quality Assurance (CQA) strategy for the country/region in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …StrategyAlign with the Head of Clinical Development Operations or Senior Director, Clinical Operations on plans for successful implementation of ... other research areas centered around rare diseases and immune disorders. Summary Senior clinical operational leader accountable for operational planning and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Job Summary: Director, Global QA Strategy & Operations ( Global R&D PV QA) is ... Global R&D PV QA and the Head of Global QA Strategy and Operations to ensure...priorities), including significant experience working cross- functionally and in global teams.Strong Industry Network in clinical development.… more
- BeOne Medicines (Emeryville, CA)
- …colleagues in clinical development, program leadership, biometrics, clinical operations , safety/pharmacovigilance, regulatory, molecular diagnostics, and ... + Clinical Development Plans + Partner with clinical operations and other functional areas for...their existing skills to oncology + Expert understanding of global clinical study design and drug development… more
- GRAIL (Menlo Park, CA)
- …please visit grail.com . The Sr. Clinical Trial Manager serves as a clinical operations leader, responsible for guiding the day-day execution of clinical ... and to be able to identify areas of improvement to drive efficiency within Clinical Operations . **Responsibilities:** + Serves as the Clinical Operations… more
- BeOne Medicines (Emeryville, CA)
- …of ICH and associated regulatory guidelines - Minimum of 4-6 years of relevant Clinical Operations experience - Minimum of 3-4 years of (CRA) monitoring ... BS/BA in a relevant scientific discipline and minimum of 4-6 years of relevant Clinical Operations experience, and minimum of 3-4 years of monitoring experience.… more
- Parexel (Des Moines, IA)
- …activity. + Develop, update, and maintain GCP inspection procedures and guidelines within Global Clinical Trial Operations (GCTO). + Contributes to the ... with Client QA and acting as the link between Clinical Development, study teams, global business functions...regulations (eg FDA, EMA, NMPA, etc.). As such, the Clinical Operations Manager (COM) is responsible for… more
- BeOne Medicines (San Mateo, CA)
- …the attention of management. + Lead and measure processes to ensure logistics operations are completed with excellence on regular basis. + Collaborate with QA ... and assess Depot vendor's performance and report Depot metrics (KPIs) to senior management. + Ensure the requirements and business process associated with… more
- Merck & Co. (Rahway, NJ)
- …discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations )Provide clinical ... Job Description Senior Principal Scientist Translational Medicine, Immunology Translational Medicine in our Research & Development Division is responsible for… more
- Insmed Incorporated (NJ)
- …patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare ... each other, and for the future of science, we're in. Are you?About the Role:The Senior Director, Head of US HCP Marketing for our TPIP program in Pulmonary Arterial… more
- Genmab (NJ)
- …working relationships with cross-functional teamsIn collaboration with medical and clinical operations teams, support Genmab-sponsored trials through trial ... and execute territory plans in alignment with regional, national, and global Medical Affairs strategiesProvide insights/feedback on emerging scientific/ clinical … more
- Insmed Incorporated (NJ)
- …data.Supports research and development programs as requested by Insmed R&D, Clinical Development & Operations , and Medical Affairs Departments.Partners with ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...of science, we're in. Are you?About the Role:The National Senior Director, US Field Medical is responsible for the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …up, model the way and enable the team to act.Provides medical leadership to:- GMA clinical operations teams as part of evidence generation forums and study teams ... function as a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, and Global Product Team to inform … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …effective project management in cross-functional drug development teams or clinical , regulatory, pharmaceutical sciences/technical operations in the ... Legend Biotech is a global biotechnology company dedicated to treating, and one...in the treatment of multiple myeloma.Legend Biotech is seeking Senior Project Manager, Site PMO as part of the… more
- Aequor (Thousand Oaks, CA)
- Senior Specialist QA Remote any time zone OK...in product volume and complexity across the enterprise (R&D, Operations , and GCO). In this vital role you will ... collaboration on the process improvement, transfer and sustainment of QMS processes, across Operations and R&D, to the Digital QMS platform for health and control… more
- Insmed Incorporated (NJ)
- …patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare ... future of science, we're in. Are you?About the Role:The Senior Director, Head of US HCP Marketing for our...with Medical Affairs and Commercial Effectiveness to ensure key clinical and research insights inform HCP strategies.Lead development and… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** As the Regional Strategic Feasibility Lead within Global Clinical Operations (GCO), you will play a vital role in collaboration with ... point of contact for the Global Strategic Feasibility and Regional Clinical Operations teams for Feasibility and Re-Feasibility activities. + Liaise… more
- GRAIL (Menlo Park, CA)
- …with cross-functional teams (eg, Regulatory, Quality Assurance, Lab Operations , Clinical Data Management, etc.), and senior leaders to establish inspection ... and CDx pipelines, develop and drive corrective/preventive action plans, and track clinical compliance-related metrics for senior leadership. + Provide routine … more
