- 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
- Insmed Incorporated (Bridgewater, NJ)
- …, Clinical Project & Planning Management is a member of the Clinical Business Operations team within Development Operations and provides oversight and ... Clinical Business Operations , and Clinical Program Optimization members within Development Operations as well as cross-functional partners including Program… 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...be responsible for a global operational strategy and investigations lead / owner for a best-in-class high volume marketed… more
- Insmed Incorporated (Bridgewater, NJ)
- …Senior Medical Director of Gene Therapy will develop, implement, and lead the gene therapy portfolio strategy and planning for Medical Affairs across all ... geographic regions ensuring a cohesive approach. This role will develop and lead all medical affairs activities ensuring partnership within the team (medical… more
- Insmed Incorporated (Bridgewater, NJ)
- …being the Technical Operations liaison to the Insmed research team for lead optimization and early development programs. This position will be the dynamic ... interaction between lead optimization research and early CMC development .Responsible for the management of API/Intermediate/RSM manufacturing operations at… more
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , Clinical ... at the program and franchise levels. May represents Clinical Operations on the Strategy and Portfolio or Clinical Sub...as programs or franchises.When sitting on a study team, lead the study team to develop a cross-functional, integrated… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primary responsibilities of this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support of projects within ... Daiichi Sankyo's Early and Late Stage Development Portfolio. The individual will play a key role...closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations , Clinical Leads and Regulatory Liasions to ensure sucessful… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …process.Monitor clinical trial performance and quality metrics and share with study team, Operations Program Lead , and Sr. Director for the compound, ... primary accountability for operational study-level timeline, cost, and quality deliverables. Lead the development of the clinical study...propose solutions, or bring to the attention of the operations lead of study team lead… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and people with disabilities. SummaryThis position will be the Clinical Science Group Lead in late phase development in the Global Clinical Science function. ... on the vision for the function. As the late development CS Group Lead , the incumbent closely...include but not limited to Group Heads in Clinical Development , Asset & Portfolio Management, Global Clinical Operations… 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 & ... pathways with functional partners to support GCO risks. This individual will also lead and manage the GCO CTOR and Strategic Vendor Oversight teams, will partner… 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 ... key responsibilities are within and for GCO to: 1) Lead and implement the establishment and oversight of an...achieve diversity in clinical trials and patient focused drug development (ie. Patient voice) that are effective, streamlined and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …plans across and effective alignment within (eg with translational research, clinical operations , clinical development , medical affairs CSPV and other internal ... areas centered around rare diseases and immune disorders. Summary A cross-Oncology Development Medical Doctor position reporting to the Head Clinical Development … 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)
- …Director Global Medical Affairs Oncology (GMA), under the direction of the Senior Director , GMA Oncology (Global Medical Affairs team lead for compound), is ... projects within a specific compound or indication. Responsibilities Support GMA the development of the Global Medical Affairs strategy and execution of the Global… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …EU SmPC, EU PL, CCDS, CCPL)for new products or products in the development phase. Independently lead cross functional teams through all labeling discussions ... companies, reinforcing the use and implementation of labeling best practices. Assist or lead the development of Standard Operating Procedures (SOPs) and process… 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 ... Controls) activities from early development to post-approval phase for biological, Cell and Gene...company goals. Participate on G-RACMC teams and support or lead on Component teams and/or serve as G-RACMC … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. Summary The AD, Global Clinical Operations (GCO) Clinical Trial Operational Risk (CTOR), will be responsible for lifecycle ... provide expert advice on identification of root causes and support development of Correction Action/Preventive Action (CAPA) plans and related effectiveness… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …global labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the US ... on RA labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the US or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of this position is to oversee bioanalysis strategy from global development and global regulatory perspectives, set standards (industry best practices), ensures ... of regulated bioanalysis will also form strategic internal (DMPRL, Clinical Operations , Data Management, Scientific Operations etc) and external partnerships… more
