- Genmab (NJ)
- …to the effective planning, and timely delivery of complete, high quality and reliable clinical trial data . The Associate Director DM will provide oversight ... excellence.Responsibilities:Contributes to and implements the strategic direction of the Clinical Data Management functional areaContributes to the overall… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with Novo Nordisk policies and procedures. Relationships This position reports to a Senior Director within the Clinical Data Science & Evidence (CDSE) - ... 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a living. Are you ready to make a difference? The Position The Director , Clinical Informatics in the Clinical Data Science & Evidence (CDSE) department ... "best practices" in informatics and associated contingencies to include healthcare and clinical data analytics, real-world data sources, data science… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …achieved according to agreed quality standards and timelines and that quality of data is suitable for regulatory submission.The Associate Director will have ... master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study Team Leader for the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global ... Plans and may perform final review. This position provides input on electronic data capture (EDC) Safety report outputs, reviews clinical study and… more
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleGenmab is searching for an experienced Director , Global Clinical Drug Supply to be part of Global ... at the forefront of bringing medicines to cancer patients and other serious diseases. Director , Global Clinical Drug Supply will work in partnership with several… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review Plan ... Director , Clinical Development Join a Legacy...Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility… more
- Insmed Incorporated (San Diego, CA)
- …for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Executive Medical Director of Ophthalmology, Clinical Development holds the responsibility ... monitoring of clinical studies, review & interpretation of clinical trial data , authoring clinical study and regulatory communications and documents,… more
- Daiichi Sankyo, Inc. (Bernards, 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
- Merck & Co. (Rockville, MD)
- …the company enterprise policy agenda.Responsibilities and activities of the Senior Director , Clinical Research Policyinclude:Leads and is responsible for the ... research environment, the latest regulations and guidance related to clinical research and data , with sound knowledge...and guidance related to clinical research and data , with sound knowledge of intelligence tools and methodsStrong… more
- Merck & Co. (Rahway, NJ)
- …help people with cancer across the globe.Working with ADT's, early- & late-stage clinical development teams, the BMx leads will develop asset-specific clinical ... biomarker strategy by incorporating critical insight from discovery biology, clinical development, diagnostics, bioinformatics, molecular assay experts, QP2 and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a difference? The Position Senior, Clinical Informatics leads the functions in the Clinical Data Science & Evidence (CDSE) department of NNI focused on ... 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
- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Clinical Trial Manager (GCTM) is accountable for the end-to-end delivery of a ... single or multiple clinical trials from strategy outline through to CSR by...to IEC/IRB commentsMonitor major protocol deviations (PDs) and trendsApprove data cleaning plansCollaborate with CPL as needed for CST/CDTEstablish… more
- Merck & Co. (Rahway, NJ)
- …molecules, biologics, and vaccinesBroad understanding of drug discovery, development and research, clinical data coding and experience working within a regulated ... Job DescriptionThe Associate Director of Scientific Nomenclature and Reference Data is responsible for assigning accurate chemical nomenclature to small… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole Summary The Hematology US Scientific Director , Medical Affairs (SDMA) is a regionally based position in our Company's Research Laboratories, US ... with organizational priorities. Along with the USMA Field Leaders (Executive Director (ED)/Associate Vice President (AV)), the SDMA is responsible for regional… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryThe Regional Medical Scientific Director is a credentialed (ie, PhD, PharmD, DNP, MD) therapeutic and disease expert who engages in ... questions about Company products. The work of an Regional Medical Scientific Director is aligned to: Scientific Exchange, Research, Scientific Congress Support, and… more
- Merck & Co. (Rahway, NJ)
- …approach, driving the development of in vitro-in vivo relationships and preclinical-to- clinical translation in bioperformance of formulationsThe Director will ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for producing scientifically ... accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines. This...strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of… more
- Merck & Co. (Lower Gwynedd, PA)
- …automation platforms, sound scientific understanding of QbD/DOE principles as well as data analysis and statistics for reporting clinical dataAbility to lead, ... Metabolism, and Bioanalytics (PDMB) Regulated Bioanalytics Department is seeking a Senior Director to lead the Regulated Robotics & LIMS team within the Exploratory… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Director , Global Oncology Commercial Pipeline Analytics, HHDDAOur Human Health Digital Data and Analytics (HHDDA) organization is ... new ways of engaging with our customers and patients by leveraging digital, data , and analytics to measure our organizational impact.The Associate Director ,… more
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