- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Associate Director , Global Strategic Operations & Capacity Planning Head as part ... leadership team. This individual will be responsible for a global operational strategy and investigations lead / owner for a best-in-class high volume marketed… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , HCP Marketing, Branded Strategy & Execution ... including field material and digital assets.Co-develop and execute the branded launch strategy , including POA and National Launch meetings.Develop Peer to Peer … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primary responsibility to collaborate with, and support the head of Global QA strategy and operations. In this position, the incumbent will take on organizational ... management team. This position will take direction from global strategy and operational QA leader, however is also accountable...may be tasked under the direction of the Global Strategy and Operations Head, to draft presentation for VP… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …thereby accomplishing corporate goals.ResponsibilitiesDevelop and implement US regulatory strategy for assigned project(s).Strategize and plan for FDA meetings ... for assigned product. Liaise, negotiate and orchestrate meetings with FDA. Prepare internal meeting minutes to capture the full discussion for archiving. Serve as the primary contact with FDA.Lead and prepare FDA submissions, including but not limited to… 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 ... manufacturing, process characterization and validation, and manufacturing CMC development strategy . Remote (only in corp. office for purposeful meetings)ResponsibilitiesResponsibilities… more
- Insmed Incorporated (Bridgewater, NJ)
- …in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , HCP Marketing will be a key member of the ... our culture. This position will report to the Senior Director , HCP and Payer Lead. This position does not...necessarily be limited to, the following:Develop and implement the strategy for the brand's personal and non-personal promotional efforts… more
- Insmed Incorporated (Bridgewater, NJ)
- …research organizations etc.) to build and to execute the bioanalytical strategy specific to clinical development programs.Participate in clinical study design and ... documentation (lab manual, protocol, report, SAP)Participate in preclinical study design and documentation as needed.Contribute to regulatory document writing (eg IB, IND, Integrated Summary of Immunogenicity).Engage in scientific advice meetings with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Associate Director FP&A position is an integral part of the finance ... way to find more optimal and cost-effective approaches that are aligned to our strategy .Financial Plan & Latest Estimates (LEs): Leads the Annual Financial Plan & LE… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization process.Experience with ... with clinical plans and marketing objectives. Experience with communicating the regulatory strategy , issues, and risks in written and verbal format to regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Associate Director , Field Medical Training will be responsible for the ... and Contingent Workers requiring therapeutic knowledge of the Daiichi Sankyo portfolio. The Associate Director , Field Medical Training will have a variety of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , Global Clinical Operations (GCO) Procedural Ownership and ... policies, and meet applicable ICH and GCP standards. The Associate Director will also be responsible for...resolution meetings, as needed.Partner with CQM to develop a strategy to help address facilitation of risk-based periodic review/update… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Build and Maintain Metrics Catalog, Dashboards Catalog along with strategy for End User Education and Dashboards adoption.External Benchmarking Competitive ... and RD Line Functions for promotion of Metrics and Dashboards strategy .Team Management Manage the Metrics Business Analyst Team Qualifications: Successful candidates… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary The primary responsibilities of this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support ... the FDA and other health authorities globallyCreates a forward-looking Diagnostic development strategy while keeping abreast of regulatory and policy updates in the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , Global Oncology Medical Affairs, Medical Intelligence is ... analogs and examples from competitors to help design their evidence generation strategy Qualifications: Successful candidates will be able to meet the qualifications… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for the ... management processes, tools, methodologies, and scientific know how for overall data collection strategy is a must for the sustainability of the Daiichi Sankyo R&D… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …inputs to decisions on business strategy given market dynamics. The Associate Director should support smooth execution of all omnichannel platforms, tools ... centered around rare diseases and immune disorders.SummaryThe primary responsibilities of the Associate Director , Omni-Channel Marketing is to develop, plan and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, ... serve as G-RACMC lead or regional submission lead. Provide regulatory guidance and strategy to CMC sub-team and G-RA teams along with other functional teams leading… 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...Support GMA the development of the Global Medical Affairs strategy and execution of the Global Medical Affairs plan… 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 ... quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with...organizations. The role is primarily responsible for Operational Study Strategy and Study Execution and in addition may have… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director , Quantitative Systems Pharmacology (QSP) will work within the ... clinical trial design. In addition, he/she will develop a QSP strategy to address prioritization across the portfolio of compounds within Oncology/Immuno-Oncology.… more
