- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Director , Global Oncology Marketing (Brand) is responsible for maximizing the commercial ... the direction of the Global Brand Lead. Responsible for actively contributing to the development of the global brand strategy and for leading the development and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …As part of leading Regulatory Intelligence, this role will lead the development and implementation of a global approach (incl. processes, roles & responsibilities, ... information into actionable insights, as they relate to DS's portfolio of development and marketed assets, and synthesize and communicate these findings to relevant… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …functional, holistic perspective; Represents clinical function at meetings with health authorities; Oversees management and performance of CRO. Occasional ... and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections of key submission documents;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, protocol profiles, and sections of submission documents under guidance ... medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the strategic… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, and analytic support ... preparation of data for statistical analysis to obtain background rates) for development of safety documents (eg, RMP), support SMTs, SERM or other safety-related… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's regulatory group in internal and ... external development project meetings. Conduct completeness, scientific accuracy, and ease...for submission. Prioritizes workload as necessary.Keeps current with latest Health Authority guidelines and provides Regulatory advice to members… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with Health Authorities- Global BDO Strategy to Improve Drug Development : Primarily participates and may occasionally lead moderately complex initiatives, with ... veterans and people with disabilities.SummaryThis position supports early phase oncology development and leads complex studies in study design, statistical analysis… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director Global Oncology Value Access & Pricing will both develop and execute ... oncology asset(s). This person will report to the Sr Director , Global Oncology Value Pricing & Access, and will...manager oversight, the individual will lead global pricing strategy development , access strategy development and partner with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …complexity including post marketing projects and those involving 3rd party development . This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) ... on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU. Preparation of updated Core… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Director , Global Oncology Medical Affairs, Evidence Generation role is responsible for ... (EGT) for the assigned compound in partnership with Global Health Economics Outcomes Research partner.- As a member of...and external communication is current and clear.- Drive the development of Areas of Interest (AOI) for Externally Sponsored… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.SummaryThe Senior Director , Global Oncology Medical Affairs, Evidence Generation role is responsible ... Generation Team (EGT) for the assigned compound in partnership with Global Health Economics Outcomes Research partner. Ensure alignment of the Integrated Evidence… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests and other devices to ... resolve complex regulatory issues and increase speed to patients.ResponsibilitiesCDx development : Provide critical strategic and tactical regulatory guidance for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with minimal supervision. This position provides input to entire drug development plans with minimal supervision and authors regulatory responses and other ... minimal supervision. This position interacts with global project teams and global Health Authorities, as well as contract research organization (CRO) programmers and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …strategy within one or more Global Project Team(s) (GPT) within Oncology Development Franchises or Business Units. Provide strategic and proactive QA Leadership for ... patient's rights and well-being and in support of successful Health Authority inspections and approvals. Lead in a proactive...Deputize for the Head of RD QA at the Development Leadership teams, as appropriate and as neededInteract with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …review of documents supporting CDx submissions to the FDA and other health authorities globally- Creates a forward-looking Diagnostic development strategy while ... (CDx) in support of projects within Daiichi Sankyo's Early and Late Stage Development Portfolio. The individual will play a key role in making Precision Medicine… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …writing the interaction document. May participate in meeting or teleconferences with Health AuthoritiesGlobal BDO Strategy to Improve Drug Development : Primarily ... with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of Health Authority expectations in the areas of Pharma Development ; preferably working in a GxP regulated environment, pharmaceutical industry.- Proven ... or without a reasonable accommodation. Education Qualifications (from an accredited college or university)- Bachelor's Degree in scientific discipline or higher in,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with or without a reasonable accommodation.Education Qualifications (from an accredited college or university)Bachelor's Degree emphasis in health sciences is ... diseases and immune disorders. Summary: Manager, Sales Training and Development - Oncology serves as the training subject matter...vendors and key senior stakeholders at Sr manager and director level in sales, sales training, and marketing on… more
- Ann Graves CDC at The Hockaday School (Dallas, TX)
- Available Position: Child Development Center Teacher (full‐time) Department: Child Development Center Reports to: Director of the Child Development ... The Hockaday School: The Hockaday School is an independent, college preparatory school for girls of strong potential and...for the young children in the CDC. All Child Development Staff care for young children by following a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …privacy, legal, compliance, IT security, etc.Responsibilities- In conjunction with the Director of Data Stewardship, Cataloging and Process, develop implement a data ... scalable approaches for data quality issue identification, support mitigation, the development and implementation of data quality standards and data protection… more
