- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …are an equal opportunity employer including veterans and people with disabilitiesSummaryThe Associate Director , Global Oncology Clinical Development (GOCD) ... generation (checklist, process map, etc.), change management and detailed analysesThe Associate Director , GOCD Functional Excellence must have excellent verbal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for ... the end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with clinical...for the data services they provide to support drug development processes and global submissions. This position provides expertise… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research 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...a specific compound or indication. Responsibilities Support GMA the development of the Global Medical Affairs strategy and execution… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …& Diagnostic (Dx) Scientists to co-facilitate interactions between external Diagnostic partners and internal Daiichi Sankyo stakeholders.ResponsibilitiesCreate and ... of slide decks for DS governance approval, align all internal & external program communications, and be involved in decision-making processes in partnership with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and ... and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal and … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …end-to-end delivery of AI/ML projects (from business understanding, over hands-on development to dissemination), to ensure high quality deliverables are on time ... and within budget. The position holder will partner with internal and external stakeholders as well as vendors to optimize AI/ML technology, processes and standards.… 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) ... of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo...may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and manage oversight. The position will partner with internal and external stakeholders to optimize Statistical methods, processes and standards. The position ... activities assigned, eg for a clinical study: provide input on the development of study protocol (design, sample size, statistical analysis strategy); Review CRF;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …development and execution of strategic change communication plans. The Associate Director will contribute to the development of these plans and most ... A key part of the Global HR team, the Associate Director of Global HR Communications and Change Management will be... external entities to ensure the … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(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 ... Teams (GPT) for the therapeutic, covering all areas from CDx assay development through CDx approval and launchLeads CDx Partner evaluation and selection activities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, ... 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)
- …The project teams will be defined based on the project needs and the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead on ... to the governance bodies. Responsibilities - Accountability to lead teams within overall CMC development project(s), to support Sr CMC Lead. In case no Sr CMC Lead… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Lead and coordinate the Site-Launch activities and associated teams for internal and external sites and development projects. Serve as the main interface to ... drugs to the sites of manufacture, both internal and external to Daiichi Sankyo, until completion of the first...Substance, Drug Product, or New Modality) process and product development preferred Travel Ability to travel up to 30%.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Oncology Value Access & Pricing will both develop ... 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)
- …with BD&O to ensure SAP updateExternal collaboration: Consults with internal experts and external KOLs, Ad Boards for protocol development ; Provides input on CRO ... of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, protocol profiles, and sections of submission documents under guidance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …high quality deliverables on time and within budget to support drug development processes and global submissions. This position provides leadership within Data ... Management by partnering with internal and external stakeholders to optimize Data Management technology, processes, and standards. Additionally, this position… more
- Merck & Co. (Rahway, NJ)
- …our pipeline and make informed decisions to manage their parts of the Research & Development division.The Associate Director , PMO People & Process Lead, is a ... Job DescriptionAssociate Director , PMO People & Process LeadGlobal Project and...fostering collaboration within and across organizational boundaries.Strong internal and/or external professional network of Research & Development … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director , ESQL is responsible for all activities at the External Entity (EE) site associated with the manufacturing of company ... to all applicable regulatory requirements, regulatory filings and company policies.The Associate Director also ensures that effective and robust Quality… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewAssociate Director , Tech Ops (Process Chemistry) will have responsibility for the ... clinical/commercial manufacturing, process characterization and validation, and manufacturing CMC development strategy. Remote (only in corp. office for purposeful… more
- Merck & Co. (Rahway, NJ)
- …join the Quantitative Pharmacology and Pharmacometrics - Immune/Oncology team in the role of Associate Director . The team is part of the Global Clinical ... Development organization and has oversight over drug ...effective communication skills. As a subject matter expert, the Associate Director within the Group will work… more
