- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. SummaryThis position supports safety monitoring and risk management activities, provides insights on current ... clinical practice and guidelines, reviews and provides written assessments...position supports a senior physician in evaluating and mitigating safety signals as they arise. Additionally, this position works… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.SummaryThis position serves as the Clinical Safety Scientist Lead for a large, late-stage program or ... safety surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s), and cross-functional team in support of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve ... standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …stud(ies).Ensures trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …are an equal opportunity employer including veterans and people with disabilitiesSummaryThe Associate Director , Global Oncology Clinical Development (GOCD) ... generation (checklist, process map, etc.), change management and detailed analysesThe Associate Director , GOCD Functional Excellence must have excellent verbal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core ... Data Sheets (CCDS) for assigned products. This position drives/leads the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products. This position ensures that draft… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …develop programming submission strategy, perform integrated analysis of efficacy and safety , generate submission data package, create TLFs to support submission QAs, ... perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting- Develop DSI programming… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …business function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure requirements are in place ... around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the...(global/ local), and not limited to: Global Project Team, Safety Management Team, Clinical Safety … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …role is primarily a tactical study delivery role, reporting into an Associate Director or above responsible for Operational Study Strategy. ... Summary The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions in the West, in adherence… more
- Insmed Incorporated (Bridgewater, NJ)
- …internal and external stakeholders (therapeutic areas, clinical pharmacology, clinical operations, non- clinical safety , contract research organizations ... for Millennials™ lists.OverviewWithin the Translational Bioanalytical Sciences (TBS) group of Clinical Development, the role focuses on LC-MS/MS of small and large… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Manager role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in...writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.Lead the CRO and vendor selection… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** This position serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple ... safety surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s), and cross-functional team in support of… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** This position supports safety monitoring and risk management activities, provides insights on current ... clinical practice and guidelines, reviews and provides written assessments...position supports a senior physician in evaluating and mitigating safety signals as they arise. Additionally, this position works… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …This position will be a member of the Risk Management Center of Excellence office who will help manage risk management initiatives and activities defined by ... leadership. Individual will provide strategic advice, teachings, and support related to risk management planning, risk management sciences, and risk management tools and resources. **Responsibilities** - Strategic Advice and Support to Global Product Teams: 1)… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- … Director to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the development, evaluation, ... scientific integrity and interpretation of study data of a clinical development program. The Associate Director...and GCP guidelines as well as applicable SOPs regarding clinical safety + Possesses proficient scientific expertise… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Associate Director , Clinical Scientist leads in the development, evaluation, planning and execution of hematology oncology clinical studies and ... on clinical studies and programs. May be responsible to manage one or more clinical scientists. As an Associate Director , a typical day may include the… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …develop programming submission strategy, perform integrated analysis of efficacy and safety , generate submission data package, create TLFs to support submission QAs, ... perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory...effective implementation of SDTM, ADaM and TLFs standard in clinical trial data analysis - Develop and maintain necessary… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, ... Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services, Project Management and Operational Management. Develop a strong, positive strategic business partnership with the global R&D business and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core ... Data Sheets (CCDS) for assigned products. This position drives/leads the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products. This position ensures that draft… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …business function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure requirements are in place ... around rare diseases and immune disorders. **Summary** The Senior Director , Head Global PV Quality (DSI/DSE) reports to the...(global/ local), and not limited to: Global Project Team, Safety Management Team, Clinical Safety … more
