- Eisai, Inc (Nutley, NJ)
- …research is required.#LI-MI1#IND123#LI-RemoteEisai Salary Transparency Language:The base salary range for the Associate Director , Clinical Data Science - ... difference. If this is your profile, we want to hear from you. The Clinical Data Science team at Eisai, Inc., is expanding its capabilities by acquiring in-house… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and management of the resources within NACD. Relationships Reports to Snr Director of Clinical Strategy and Business Operations within Operational Excellence ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Merck & Co. (North Wales, PA)
- … clinical data /medical protocol-deviations in collaboration with the Clinical Director .Builds talent and capabilities of direct/indirect team members ... position drives scientific planning, strategy and execution of Phase 1-4 clinical studies.-Under the direction of the Program Lead, you will collaborate… 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 ... industry standard data collection practices preferred- 7+ years Clinical data management experience in a medical device, pharmaceutical company, or similar… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… 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 ... Quantitative Clinical Pharmacology (QCP) group to develop and apply QSP...virtual population workflow is desirableExperience with general programming and data analysis tools/languages such as Python or R would… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary Position manages the end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other ... development processes and global submissions. This position provides leadership within Data Management by partnering with internal and external stakeholders to… more
- Merck & Co. (Rahway, NJ)
- …us. - The recently opened new location in Zurich focuses on accelerating research, data and commercialization of our medicines and vaccines. The new office will be ... by teams working in strategic and operational roles in medical affairs, clinical development, access and marketing operations functions. Current Employees apply HERE… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …technology transfer, site-to-site technology transfers and PPQ as needed. Conduct data review and analysis, data -driven decision-making process, and support ... data transfer to the appropriate data repository - liaison between the Tech Strategy (...manufacturing sites.- Conduct scouting activities and recommend CDMOs for clinical and launch site selection from Tech Mgmt. (mAb,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …independently in order to accomplish objectives. Relationships Reports to the Director , Patient Support Programs Rare Disease. Key internal relationships include ... patient HUB patient support programs Develop performance dashboards and interpret hub data for purposes of assessing market access trends, hub program utilization,… more
- Merck & Co. (Rahway, NJ)
- …the Quantitative Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical ... of drug development and effective communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will work closely with teams… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Marketing Women's Cancers Associate Director is a vital role that will be responsible for shaping Women's Cancers indications across ... teams including Market Access, Medical, Market Research, Human Health Digital Data & Analytics (HHDDA), Human Health International (HHI), Key Regional/Market teams,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, ... study findings through presentations and/or publications in peer-reviewed scientific journalsAssess clinical trial and/or other data sources to contextualize… more
- Merck & Co. (Rahway, NJ)
- …pipeline products to produce safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate Director , is a ... for growth opportunitiesThe Vocabulary Specialist may lead or participate in:Internal clinical data standards forumsStandards development teams and data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …training and ensure effective implementation of SDTM, ADaM and TLFs standard in clinical trial data analysis- Develop and maintain necessary programming macros ... review of Study Date Tabulation Model (SDTM) and analysis (including Analysis Data Model (ADaM)) datasets as well as TLFs generated by statistical vendor,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to realize your potential? The Position To support the Director of US Tax Operations in leading and managing tax operations, tax compliance, ... with key stakeholders and developing self, team and organization. Relationships Reports to Director of US Tax Operations. Member of NNI Finance & Operations -… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core ... Data Sheets (CCDS) for assigned products. This position drives/leads...all applicable regulations and guidelines and with Company Core Data Sheets and manages deviations. This position interacts across… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies ... on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data .-...with data manager to ensure high quality data .- Drug Development Strategy: Provides input to multiple aspects… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
