- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for the Global Finance and Procurement organization and oversee project management for Finance, driving coordination, communication, and change management ... across various initiatives. Through a passion for capability building and strong project management skills, this role will engage with diverse stakeholders across… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the vision and ... regulatory requirements and ICH guidance. This position requires excellent project and people management skills, verbal/written skills, analytical, organizational,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary:The Associate Director , Oncology Value & Market Dynamics Training Manager is responsible for ... to access for patients across our portfolio of products. The Associate Director will develop, in partnership with other key stakeholders, innovative solutions for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Team Working Group (WG) cross-functional meetings. Serve as member of the Joint Project Team (JPT) with the Diagnostic (Dx) Partner to communicate key RA updates ... from the drug side, as needed. Provide RA specific inputs into CDx Risk Management plans for individual projects/indications. Assist the CDx team with the creation of contingency/backup plans for CDx submission. Health Authority Submission Preparation : Assist… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management ... data visualizations, external data acquisition and validation, and tools to support project portfolio across drug programs. This role is responsible for ensuring the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary: The Associate Director , Laboratory Data Management is accountable for the end-to-end delivery of ... skills in working in a fast-paced environment, continuous improvement, project management, change management, and risk management. Responsibilities: Leadership,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …participate/contribute to discussions in applicable working teams, technical teams, project teams, etc. Qualifications: Successful candidates will be able to ... Qualifications 7 or More Years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development or technical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team and serves ... as ad hoc member to the Global Project Team for late stage projects. This position manages...of contact to cross-functional teams on US/EU RA CMC project issues.Execution of Strategy and Submissions: Develops strategy with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is accountable ... designated programs.Ensure proactive representation of Quality professionals at strategic non- project team and at MA strategic discussions.Lead the Quality Reviews… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …supported by regular audits, data maintenance and continuous improvement processes. Project Management: Effective management of timelines and deliverables, along with ... experience in Agile and Waterfall methodologies, is essential. Preferred SkillsPractical experience in SuccessFactors as a functional consultant or configurator or SuccessFactors Certification would be highly regarded preferredStrong people leadership skills… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as well as other research areas centered around rare diseases and immune disorders.SummaryThe Director , Clinical Safety, will be a product safety lead or part of a ... Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other departments to strategically… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …this position has advanced skills in continuous improvement, project management, change management, and risk managementResponsibilities: Leadership, Direction, ... department level.Provides the highest level of CRO/vendor oversight to ensure project plans are executed properly (eg, operational leadership teams). Functional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of companion diagnostics (CDx) strategy in support of projects and Global Project Teams within Daiichi Sankyo's Early and Late-Stage Development Portfolio. The ... to benefit from our therapeutics. Responsibilities Contributes to CDx project teams for the diagnostic, under the direction of...point of contact to the Dx partner for CDx project contracts. Supports CDx analytical and clinical validation studies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …scientific direction to Clinical Operations. Represents Clinical Development on Project Teams.Responsibilities: Study Strategy: Provides the strategic direction to ... Biostatistics Data Management & Data Ops for EDC, edit checks, data quality listings, SAP, Data Management plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …components of a large-scale global clinical program using strong clinical project and program management, leadership, decision-making ability, people management, and ... Strategy:Align with the Head of Clinical Development Operations or Senior Director , Clinical Operations on plans for successful implementation of studies.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategiesExecutive Advisory Communications: provide strategic insights and deliver concise updates on project statuses and next steps to prepare the Head of Late ... input and facilitate efficient decision makingIn conjunction with finance and Project Management support the Head of Oncology Late-Stage Development in management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Executive Director , Head of Center of Excellence (CoE), Global Medical Safety will ... reporting, risk management, and/or translational researchMust have excellent communication, project management, writing and analytic skillsMust be organizational leader… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …this job is to provide statistical programming technical support to DSI project teams on all statistical programming deliverables and programming submission. It will ... and build up standard on SDTM/ADaM datasets, and TFLs.Responsibilities:- Supporting project lead on outsourced projects, act as statistical programming subject… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Responsibilities:Supports positions from Director through Vice President, as needed, and in so doing will ... provide direct assistance to the project teams, committees and the department/function.Attend GPT meetings and...efficient ways of working within GPM&L or on a project team, enhanced collaboration tools, etc.Schedule and implement on-site/off-site… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …computational pathology approaches,Plan and deliver bioinformatics and correlative analyses to project teams in support of the translational science and digital and ... computational pathology goals.,Collaborate with the cross-functional stakeholders to shape our ecosystem both by improvements in data and analysis platforms as well as processes for data and analyses delivery.Evaluate data resources and analysis methodologies,… more
