- Eisai, Inc (Nutley, NJ)
- …on project teams. This involves providing valuable statistical input on observational studies , actively participating in the formulation of study designs and ... diverse data sources (eg, clinical trial data, patient registries, and observational studies ) to support study design and otcomes measured.Align the… more
- Eisai, Inc (NJ)
- …of trial results, final study report conclusions and publications.Serve as study director for trials: Provide critical medical input into the lifecycle ... profile, we want to hear from you. The Medical Director , US Medical Affairs provides medical leadership for medical...area to provide strategic input for the development of product strategies and liaises with external stakeholders to solicit… more
- Eisai, Inc (Nutley, NJ)
- …of trial results, final study report conclusions and publications. Serve as study director for trials. Provide critical medical input into the lifecycle ... area to provide strategic input for the development of product strategies and liaise with external stakeholders to solicit...Strategic Plans: Under the direction of the Senior Medical Director , work with key stakeholders, management , and… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole Summary: The Oncology Regional Medical Scientific Director (RMSD) is a credentialed (ie, PhD, PharmD, DNP, MD) therapeutic and disease expert who ... Scientific Leaders (SLs). The role provides balanced, factual, scientific information about non- product areas of interest to the Company and replies to scientific… more
- Merck & Co. (Rahway, NJ)
- …The chosen candidate will be responsible for creating and executing the product strategy, adoption, deployment, marketing, and commercial activation for the new ... increase sales, and capture market share by offering guidance and updating product profiles in the SenseHub Swine Ecosystem.It's essential that the person in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and support to an expanding global manufacturing network for best-in-class CAR-T product . Management oversight and/or contribute to strategic capacity plans/COGs ... in the treatment of multiple myeloma. Legend Biotech is seeking Associate Director , Global Strategy & Investigations Owner/Lead as part of the Technical Operations… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics ... communication/publication components of overall medical operating plan.The Sr Medical Director provides strategic development, planning, implementation, and oversight of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Execution: Clinical Study Lead (CSL) for large Phase 3 registrational study (ies); Develop prospective contingency plans for management of key risks in a ... Present results to regulatory agencies during pre-submission meetings; Interpret study results in context of other studies ...Study Team (IST) representative or IST leader on study team; Responsible before senior management for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Provide strategic leadership for all statistical programming activity related to study , project and submission. Manage CRO to ensure high quality compound ... harmonization of programming processes supporting global submission.Responsibilities- Statistical Programming Management : Coordinates outsourced statistical programming of analysis data sets… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Senior Director , Global Oncology Medical Affairs is responsible for developing the Global ... 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)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Director , Clinical Safety, will be a product safety lead or part of ... , and provide safety leadership including but not limited to clinical studies , post-marketing surveillance, signal detection and management , important safety… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to or independently leads the design, preparation and analysis of epidemiologic studies , including real-word evidence (RWE), supporting senior management in ... centered around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, and analytic support… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a collaborative work culture, including direct partnership with the Operations Director (s) Stakeholder management : Build strong internal and external ... device management ) Responsible to ensure timely availability of clinical study materials and ancillary supplies to North America distribution depots, and/or… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole Summary:The Global Senior Director Medical Affairs (GDMA) Immunology/Pipeline & Biomarkers will be responsible for driving execution of ... TA in key countries and regions. They are impactful members of Product Development Team sub-teams and Global Human Health commercialization teams. They collaborate… more
- 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 ... provide input as an active part of the Global Product Team- Provide commercial insights to RD for new...decisions- Support and provide commercial input/needs to individual clinical study designs, amendments, and readouts (Choice of the comparator,… more
- Eisai, Inc (Exton, PA)
- …If this is your profile, we want to hear from you. Job Summary Oversee product release and stability testing at sites in the US and internationally. This position ... spend a significant amount of their time troubleshooting assays, designing future studies , overseeing assay validation and interacting with QA to determine … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …plan-ning and project strategic documents, including NNI Evidence Generation Plans and Product Development Plans Clinical study management : Provide regional ... education and collecting data to support efficacy and new product development, CMR is involved. The one thing that...clinical expertise in design, implementation and monitoring of clinical studies (from Phase 1 to 4) in a team… more
- Merck & Co. (Rahway, NJ)
- … product based on ongoing large CVOT (Cardiovascular Outcomes Trial) study .Budget Management :Manage the marketing budget and resources effectively to maximize ... the growth and success of our Cardiometabolic portfolio. Reporting to the Executive Director and Global Commercial Leader for the sGC alliance, you will be… 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
- Tris Pharma (Monmouth Junction, NJ)
- …success.We have an immediate opening in our Monmouth Junction, NJ facility for a Director , Drug Safety. The Director , Drug Safety is responsible for planning, ... directing, coordinating and prioritizing activities of the product safety team and providing oversight of Pharmacovigilance (PV) vendors in all aspects of PV… more
