- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.SummaryThe Associate Director , Regulatory Operations - Dossier Planning is responsible for ... but not limited to, original INDs, original and supplemental NDAs/BLAs/MAAs. The Associate Director partners with the Head of Regulatory Operations in developing… more
- Merck & Co. (Rahway, NJ)
- Job Description Position Description The Associate Director , Technical Operations within Global Clinical Supply (GCS) is responsible for managing all aspects of ... infrastructure-related projects to establish, upgrade, and modernize Clinical Supply Operations (CSO) facilities.-Specifically, this role will: Monitor utilization of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the ... Operations team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide strategic… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Associate Director , Global Strategic Operations & Capacity Planning Head as part of ... the Technical Operations team based in Raritan, New Jersey. Role Overview...This individual is required to manage a global strategic operations to ensure that available and future capacity can… more
- Eisai, Inc (Nutley, NJ)
- …support of operational and business matters. This role will report into the Director , Government Pricing and Contract Operations and collaborate across all ... functions. Essential Functions Lead the Contract Operations team ensuring timely and accurate review and processing of claims.Serve as a subject matter expert… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Associate Director , Global Clinical Operations (GCO) Procedural Ownership and Life ... and policies, and meet applicable ICH and GCP standards. The Associate Director will also be responsible for the creation, management, and documentation of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Director , Global Clinical Operations (GCO) Clinical Trial Operational Risk & ... oversight standard practices across GCO and work with Global Clinical Operations , as needed, to understand business priorities.Develop and establish more streamlined… more
- Merck & Co. (Rahway, NJ)
- …overall success of the pilot plant. The Facility Lead position reports to the Director of Operations /Head of SSO Pilot Plant and the successful candidate will ... technical, and operational experience to lead and support facility operations , process development activities, compliance investigations/change management, authoring of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) Group Lead will ... to Group Heads in Clinical Development, Asset & Portfolio Management, Global Clinical Operations , BDM and DLT members. He/she will also serve as the Clinical Science… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Vaccines, Diagnostics, Combinations Products, including experience in sterile operations , antibody manufacturing.Proven expertise in continuous improvement, change ... management, and evolving the capabilities of an organization required.Demonstrated experience working directly with global Health Authorities (FDA,EMA, MHRA) and other government and local agencies required.Must have strong working knowledge of the end-to-end… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction of the Senior ... Director , GMA Oncology (Global Medical Affairs team lead for...execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders.Provides support in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing and ... assigned products/project areas such as the clinical supplies organization, Reg Operations , Medical Affairs and labelling.- Participates in meetings with Health… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in a global matrix of biomarker and translational scientists and clinical operations . The candidate must have effective project management skills and communicate ... Translational Scientists, Companion Diagnostic Scientists and Clinical Scientists and Operations Leads in the review of clinical protocols, laboratory instructions,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. SummaryThis new role is within R&D reporting into Global Clinical Operations (GCO) and the fundamental responsibility is dedicated to GCO. This role ... of experience required Experience Qualifications.7 or More Years 7 years clinical operations experience in trial diversity and patient access and/or clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and provides written assessments of relevant medical topics, and supports PV Operations ' medical review function. This position supports a senior physician in ... evaluating and mitigating safety signals as they arise. Additionally, this position works with other CSPV staff and cross functional Safety Management Team (SMT) members, often handling straight-forward CSPV tasks such as single event level AE causality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …across and effective alignment within (eg with translational research, clinical operations , clinical development, medical affairs CSPV and other internal groups) and ... outside of Daiichi Sankyo (eg clinical trial sites, CROs, collaboration partners); Supports effective direct communication with clinical sites in collaboration with clinical development staff.Consults with KEE's for advice on complex patient safety issues.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …roles in Global DX / GDO / GCO / BDM / RD Finance/ CSPV/ Regulatory Operations / QA to ensure optimal definition and adoption of metrics. Act as a Liaison between ... MARS and RD Line Functions for promotion of Metrics and Dashboards strategy.Team Management Manage the Metrics Business Analyst Team Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.SummaryThe Director , Medical Content & Training (MCT) Excellence and Innovation is ... identifying the latest digital tools and technologies to support MCT activities. The Director serves as primary functional partner and MCT subject matter expert for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary:The Director , Global Medical Affairs (GMA), Gyn Oncology, under the direction of the ... Senior Director , GMA Oncology (Global Medical Affairs team lead for...execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders. Provides support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations , Clinical Leads and Regulatory Liaisons to ensure successful implementation ... of CDx and data collectionSupports Regulatory affairs in providing content and providing review of documents supporting CDx submissions to the FDA and other health authorities globallyFor late-stage programs, executes the Diagnostic development strategy for a… more
