- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... communication between CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) review- Conducts clinical data review per Integrated Data Review Plan- Accountable ... areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical ...Monitor (MM):- Provides oversight to the CRO MM for clinical data review activities- May support addressing… 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 PlanAccountable for ... Organization (CRO) Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility and medical… more
- Merck & Co. (Rahway, NJ)
- …vendor assay statement of work and data transfer specifications to the clinical teamsWork with data management to effectively transfer biomarker ... the Integrated Biomarker Operations organization to provide biomarker project management and operational expertise to support cross-functional clinical...data to clinical data repository from external biomarker vendorsWork… more
- Merck & Co. (Rahway, NJ)
- …related drug/vaccine projects in Late Development Statistics.Lead the interaction with Clinical , Regulatory, Statistical Programming, Data Management , and ... Job DescriptionPosition Description: Senior Principal Scientist, Biostatistics (Hybrid) In BARDS (Biostatistics...design and analysis of clinical trialsStrong project management skills. --Solid knowledge of-statistical and data … more
- Eclaro (Berkeley Heights, NJ)
- …then take a chance at this rewarding opportunity! Position Overview: The Clinical Trial Disclosure Senior Specialist will provide the operational support ... Clinical Trials Disclosure Specialist Job Number: 24-02719 Be...etc.) Familiarity and comfortability working with and discussing scientific data Project and stakeholder management experience Demonstrated… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Track record of scientific publications strongly preferred Working knowledge of biostatistics, data management , clinical operations and scientific and ... inquiries Lend clinical expertise to the Statistical Analysis Plan development and data management , and work closely with statistical programming and data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …assessing competitive impact to the disease strategy and the strategic choices for clinical development and data generation- Develop and define DAST best ... required- Prior experience in project management or leading change management initiatives preferred- Prior experience in clinical development, Medical… more
- Merck & Co. (Rahway, NJ)
- …contribute to value evidence strategies for in-line and pipeline products. Obtain senior management approval of value evidence generation plans. Provide outcomes ... improve patient health outcomes. Under the guidance of a senior leader, this individual will support one or more...dossiers for US payers, and Global Value Dossiers.Develop supplementary clinical data package for submission to Health… more
- Genmab (Plainsboro, NJ)
- …As part of our expanding US Medical Affairs (USMA) team, Genmab is seeking a Senior Director, USMA Solid Tumor Portfolio. This role will report to the VP/Head of US ... solid tumor therapies and relevant studiesProvides US market input to Global clinical development and Global Medical Affairs programs, staying abreast of the… more
- Genmab (Plainsboro, NJ)
- …authorities. You will report to the Director, Programming, and work closely with Data Management , Clinical Programming, Statistics, Medical Writing, and ... authentic is essential to fulfilling our purpose.The Role & Department As a Senior Programming Associate or Programming Manager, you will be in the Statistical… more
- Eisai, Inc (Nutley, NJ)
- …is driven to use cutting edge modeling approaches to advance the clinical and translational research in Neuroscience. This individual will provide scientific ... across all phases of drug development. The complexity and scale of data being generated has grown significantly and requires strong scientific contributions to… more
- Genmab (Plainsboro, NJ)
- …our purpose.Reporting to the VP, Head of Global Drug Safety & PV, the Senior Director, Global Drug Safety & Pharmacovigilance Physician serves as the safety expert ... safety related deliverables including signal, benefit-risk evaluation, and risk management activities. This individual must effectively interface cross-functionally at… more
- Merck & Co. (Rahway, NJ)
- …stakeholders across organizations such as Regulatory CMC, formulation functions, and clinical functions to ensure timebound progression of portfolio, initiatives for ... driving the development of in vitro-in vivo relationships and preclinical-to- clinical translation in bioperformance of formulationsThe Director will report to… more
- Merck & Co. (Rahway, NJ)
- …technical reports and regulatory documents, presenting technical data , and project management . You will serve as a senior scientific leader and provide ... between the functions supporting the pipeline (ie- quality, regulatory, clinical development; chemistry, manufacturing, and control (CMC); supply chain, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with stakeholders across Clinical Medical and Regulatory (CMR), including the NACO senior leadership team and line of business management team, as well as ... maintaining strong communication channels. This position is accountable for the financial management and budget development of North America Clinical Operations… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of experience with Supplier Management , Research Administration, Grant Operations, Grant Management , clinical trial management , or a similar research ... 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)
- …East Coast Development Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management , Biostatistics, ... External stakeholders include Healthcare professionals, HAs, ECs, DMCs, and Academia. Line management of Senior Global Safety Lead(s), Global Safety Lead(s) and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …East Coast Development Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management , Biostatistics, ... MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …launch experience in a marketing role preferred Strong communication and stakeholder management skills, with ability to influence senior leaders and collaborate ... strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our… more
