- Insmed Incorporated (Bridgewater, NJ)
- …required for the successful and timely completion of cross-functional plans. The Sr. Director of Program Management will utilize best-in-class program ... Plan and associated functional plans. As a leader, the Sr. Director of Program Management will provide cross-functional operational and program… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders.SummaryThis position is responsible for providing project management , drug development expertise to Global Project Teams including strategic ... partnering with the Global Team leader as the Project Management lead on drug development projects. This position can...these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …training program .Leadership, support and system administration for the FMA knowledge management system(s) The Associate Director will also be responsible for ... around rare diseases and immune disorders. Summary: The Associate Director , Field Medical Training will be responsible for the...strategic planning and project management for projects aimed at developing training materials, tools… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a large-scale global clinical program using strong clinical project and program management , leadership, decision-making ability, people management , and ... with the Head of Clinical Development Operations or Senior Director , Clinical Operations on plans for successful implementation of...on plans for successful implementation of studies. Responsible for management of compounds at the program and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of Clinical Development processes. Job Description:Execute an overarching safety program tailored for AEs from end-to-end: understanding predisposing non-clinical ... and clinical factors, diagnosis, effective management during clinical trials and beyond in post approval setting.Responsible for the execution of key safety… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …data protection and privacy laws, utilizing various elements of DSI's Privacy management program elements (eg policies, guideline, standards, tools, procedures, ... research areas centered around rare diseases and immune disorders.Summary The Associate Director , Privacy & Compliance Investigations, is a member of the Compliance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation of developmental and ... milestones of trial, clinical trial plan and contingency planning, Analyzes, updates management on potential risks to study deliverables, Provides input on ICF… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical trial performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for the compound, on regular basis ... Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at the study… 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...lead for compound), is responsible for assisting with defining compound/ program medical strategies and for leading select medical affairs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for the development, maintenance, ... Liquid tumors, understanding of the CDISC (SDTM, ODM.XML, CDASH) industry standards, Metadata management and Data Mappings and are some of the key requirements of… more
- Eisai, Inc (Nutley, NJ)
- …and/or consultants. Contributes to management of key portfolio and program management managed service providers including financial management ... a vital member of the Americas CIO Office, the Director will also support the Global CIO Office leadership...and developing procedures for successful implementation.Americas IT Portfolio / Program / Project Management Office Services and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global Head RDPVQA, ... impacting products from a quality perspective. Provide updates to management on MTP strategy for PV QA area and...to ensure Quality is consistently and proactively represented at program level and along the GvP modules in support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary Oversees early-stage trials, such as global clinical development program for multiple product candidates with one or more indications; Interacts ... strategy; Accountable for performance of CROs; Routine interactions with senior management of CRO, as needed; Accountable for clinical development plans, protocol… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple early-stage programs, in order to proactively perform safety surveillance ... and risk management in partnership with Product Safety Lead(s), Clinical Safety...the Clinical Safety Scientist Lead for a large, late-stage program or multiple early-stage programs, in order to proactively… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) Group Lead will ... be responsible for overseeing multiple program -level CS Asset Leads who are managing a team...to Group Heads in Clinical Development, Asset & Portfolio Management , Global Clinical Operations, BDM and DLT membersHe/she will… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …processes and global submissions. This position provides leadership within Data Management by partnering with internal and external stakeholders to optimize medical ... greater complexity.Ensures medical coding deliverables for all studies within the project/ program level meets quality, time, and cost effectiveDevelop and lead… 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...lead for compound), is responsible for assisting with defining compound/ program medical strategies and for leading select Medical Affairs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as management of adverse events based upon approved Safety Management Team (SMT) materials- Supports overall program safety reporting (eg, Periodic ... areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders.SummaryOversees a number of trials of a multinational program in a specific indication, ie, multiple multinational phase II/III clinical ... perspective; Represents clinical function at meetings with health authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …group and high-complexity disease work to support critical strategic choices for the clinical program . The DAST Director will collaborate with the DAST Lead and ... senior leaders with collaborative mindset required- Prior experience in project management or leading change management initiatives preferred- Prior experience… more
