- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a non-project initiative in support of these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director , US Head ... scope change proposals and stage gate proposals for formal presentation to senior management .Is comfortable working independently within a matrix environment and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Study Team (IST) representative or IST leader on study team; Responsible before senior management for the creation and execution of development strategies for ... perspective; Represents clinical function at meetings with health authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Senior Director , Global Oncology Medical Affairs is responsible for ... of the activities in the GMA plan including Launch Readiness and Life Cycle Management for the assigned compound and will report into the Global Oncology Medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …simultaneously. preferred- 4 or More Years Extensive experience in project management , process, product , and/or analytical development activities and ... of the project. The CMC Lead will support the Sr . CMC Lead on complex and/or late-stage project or...timeline, achievement of defined milestones and overall project risk management . He/she will assess project issues and develop resolutions… more
- Merck & Co. (Rahway, NJ)
- …these requirements across stakeholders.- Reviews draft policy and standards.Communicates with senior management within our Company and the contractor ... activities supporting the production of clinical supplies with focus on drug product . Additionally, experience in medical device and/or combination products would be… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as early as possible. This led us to create the Translational Patient Safety Senior Director position, which will have unique exposure to Daiichi Sankyo's global ... drug portfolio from the Research stage to post marketing/lifecycle management . Our expectation is that the person filling this role will pioneer and eventually lead… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, ... drug products consistent with the company goals; specifically, for the life-cycle management of NDAs/BLAs. This individual will be responsible for working on… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …timelines, milestones and goals to the project team, department leadership, and senior management .Ensure project documents are complete, current, and available ... pharma/diagnostic development team. preferredKnowledge of design control, market and product requirements management , and the IVD development process… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a ( Sr .) Director , Cell Therapy as part of the US R&D team based in ... relevant industry experience in immunotherapy of cancer. 6+ years of management experience in building, leading teams successfully. Expertise in engineering,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …access strategy for the assigned oncology asset(s). This person will report to the Sr Director , Global Oncology Value Pricing & Access, and will be responsible ... areas centered around rare diseases and immune disorders. Summary The Associate Director Global Oncology Value Access & Pricing will both develop and execute… more
- Insmed Incorporated (Bridgewater, NJ)
- …communication required for the successful and timely completion of cross-functional plans. The Sr . Director of Program Management will utilize best-in-class ... Plan and associated functional plans. As a leader, the Sr . Director of Program Management ...processes. Drive implementation of key program documentation - Target Product Profile Strategic Development plans, Dashboards, Risk assessments and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …analysis of epidemiologic studies, including real-word evidence (RWE), supporting senior management in various epidemiological activities.This position ... centered around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, and analytic support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disease work to support critical strategic choices for the clinical program. The DAST Director will collaborate with the DAST Lead and core DAST membership to build ... on customer insights, external landscape, and internal information including overall product development plans. - Proactive planning for asset milestones to account… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … senior leaders with collaborative mindsetPREFERREDPrior experience in project management or leading change management initiatives.Prior experience in ... disease work to support critical strategic choices for the clinical program. The DAST Director will collaborate with the DAST Lead and core DAST membership to build… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …leading projects with high impact. preferredAbility to effectively interact with and present to senior management at all levels, as well as to external audiences ... Head of RD QA with Quality Reviews of respective product profile to ensure appropriate management review...Development Leadership teams, as appropriate and as neededInteract with senior Oncology Franchise leadership teams to ensure Quality is… more
- Insmed Incorporated (Bridgewater, NJ)
- …New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance, the Director , Quality Operations will ... not necessarily be limited to, the following: Responsible for final product Quality release/rejection and related processes.Partner with other Regional Quality… more
- Merck & Co. (Rahway, NJ)
- …strategic counselor to support pneumococcal and pediatric communications and issues management , in coordination with Director , Global Vaccines Communications. ... Product communications experience; preferably within vaccines. Strong project management skills with proven success managing and executing major projects.… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and ... and scientific communication/publication components of overall medical operating plan.The Sr Medical Director provides strategic development, planning,… more
- Merck & Co. (Rahway, NJ)
- …drug/vaccine projects.Interacts with Clinical, Regulatory, Statistical Programming, Data Management , and our Company's Research Laboratories Scientists in long-range ... in cross-functional teams for the strategic planning and execution for product development and worldwide regulatory submissions.Lead a team of statisticians and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionFLEx is a set of multi-modality Drug Product development and GMP clinical manufacturing assets being constructed in the Rahway, New Jersey site, to ... includes operations that support end-to-end GMP clinical supply manufacture and product /process development, as well as oversight of the Enterprise Resource Planning… more
