- Daiichi Sankyo, Inc. (Bernards, NJ)
- …products. When goals are tactically misaligned or at risk for these assets, this leader will be responsible for bringing the issue and potential solutions to the ... matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions, including but not limited to briefing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of PJ Lead and Tech Unit.- Provides leadership in the project/development team , as Matrix Lead , interfacing with various site locations globally and on ... research areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies within projects, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …analytics, testing, and integration, to ensure cohesive and comprehensive service delivery. The lead will provide technical leadership, guiding the team in the ... are met according to agreed timelines and quality standards. Lead a team of professionals specializing in...agreed timelines and quality standards. Lead a team of professionals specializing in intelligent automation, solution architecture,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …bodies.Triage, resolve or escalate study issues /risk mitigations to the Operations Program Lead and study team leader .Ensure adherence to internal ... against trial progress and bring deviations to the Operational program Lead and study team leader . Review and approve Vendor invoices, including investigator… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …options analysis of team 's proposals in partnership with a Global Team leader for high complexity projects/programs. Works effectively across organizational ... Project Team (s) in partnership with the Global Team Leader to drive strategy development and...annual goals.Responsible for developing and maintaining a high performing team .Generate critical path analyses and lead scenario… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …plan. This position is accountable for partnering with the Global Team leader as the Project Management lead on drug development projects. This position ... supporting divisional and departmental level objectives and may also lead a non-project initiative in support of these objectives..... Manages the GPT in partnership with the Global Team Leader in driving strategy development and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …all activities and projects Responsibilities GMAT/Function SupportIn close collaboration with the Team Lead (GMAT or Function), establish a strategic plan for ... monitoring the activities per the Business Plan and priorities.Support Team Lead to manage GOMA project/activities, including ensuring that the GMAT/Function … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …includes individual studies as well as programs or franchises.When sitting on a study team , lead the study team to develop a cross-functional, integrated ... needs of the overall development plan agreed to by the Global Project Team (GPT). Lead site selection and site qualification discussions, kick-off meetings and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …inspections in the US, in collaboration with the Global RD/PV QA team .RESPONSIBLITIESProgram oversight: Support the Global Quality Lead (s) (GQLs) and Regional ... assigned programs and in close collaboration with R&D Quality team members to ensure that the organization is in...perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality Leads (RQLs), who are… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …has both leadership and management responsibilities and is considered a global leader for a therapeutic area or a large program in CSPV ... organization.ResponsibiliteLeading efficiently and successfully a team of physicians and scientists, accountable for safety surveillance and risk management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and ensure delivery of RBQM CSM Training with Learning and Development team members. Lead development and implementation of process improvement initiatives ... other key drivers of enhanced quality.Aligns with the RBQM Risk Management Lead on critical-to-quality factors and study-level critical variables and processes, as a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategy with the external innovation ecosystem, internal stakeholder communication, and GBD team training & development efforts. This experienced leader will ... associated communications, identifying and supporting thought-leadership opportunities for the team , and more. Supports corporate communications with messaging and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, protocol profiles, and ... in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL)Study Planning and Execution: Provides input on major milestones of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders.SummaryThe Director, Clinical Safety, will be a product safety lead or part of a product safety team , and be responsible for ... through commercialization).ResponsibilitiesDepending on the status of development of the compound, lead and medical-scientifically direct a team of junior… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Summary The purpose of this job is to lead certain pipeline support activities and assist in the identification, coordination assessment, ... meetings; leading negotiation sessions in concert with senior GBD Transactions team members; and alliance management participation following successful completion of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …opportunity assessments consistent with our corporate business development strategy. This position may lead a small team and will report to the Head of ... around rare diseases and immune disorders. Summary This position will lead the valuation processes for in-licensing, out-licensing, co-development and/or acquiring… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to collect information, analyze quality related process, define strategies to lead to the development and implementation of quality improvement initiatives across ... and initiatives, focusing on enhancing processes efficiency, culture permeation and team capabilities.The incumbent will bring a combination of technical expertise,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …HCM Platforms and processes. This position will act as the functional lead with technical and operational expertise across multiple HRMS applications, possessing ... and maintenance of the Company's global HRIS system (ie, SAP SuccessFactors). Lead respective workstream(s) to gather, document, implement and validate all system… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with the New Product or Commercial Brand Teams, the Medical Affairs lead develops the medical/commercial strategy based on the scientific development and appropriate ... Affairs to external stakeholders. Oversee a Medical Affairs oncology team that works alongside Oncology Field Medical Affairs for...For Oncology portfolio serve as the US Medical Affairs lead or Global lead in development committees… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of the ... well as management of adverse events based upon approved Safety Management Team (SMT) materialsSupports overall program safety reporting (eg, Periodic Safety Update… more
