- Merck & Co. (Rahway, NJ)
- …to: Collaborate closely with biomarker scientists and project teams to plan clinical trial biomarker set-up using logistical strategies to ensure efficient ... Preferred Experience and Skills: Drug discovery experience, including familiarity with clinical trial execution in Oncology studies. Biomarker assay experience… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …deep understanding of industry trends and best practices in clinical trial diversity to drive informed decision-making with management Experience in ICH-GCP ... Research Equity (CRE) strategy integrating diversity and health equity systematically in clinical trial planning and execution. This role will create an equity… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... Planning and Execution: Provides input on major milestones of trial , clinical trial plan and...CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates… more
- Merck & Co. (Rahway, NJ)
- …to: Collaborate closely with biomarker scientists and project teams to plan clinical trial biomarker set-up using logistical strategies to ensure efficient ... Experience and Skills: Drug discovery experience, including familiarity with clinical trial execution in Oncology studiesBiomarker assay experience… more
- Merck & Co. (Rahway, NJ)
- …research activities for innovative statistical methods and applications in clinical trial development.Collaborates in publication of research results ... processing software eg SAS and/or R.-Solid understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V.-Excellent oral and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Provides medical input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the site feasibility ... other research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the site feasibility ... other research areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an… more
- Merck & Co. (North Wales, PA)
- …years of experience with all of the following: SAS programming in a clinical trial environment including data steps, procedures, SAS/MACRO, and SAS/GRAPH; ... which describe the methodology to be programmed; applying statistical terminology and clinical data management concepts; CDISC and ADaM standards; ensuring… more
- Merck & Co. (Rahway, NJ)
- …optimal trial design and monitoring of studies, producing high-quality clinical documents and presentations. The position requires a solid understanding of the ... in the late development of assets within the Metabolism Section of Global Clinical DevelopmentMay serve as a senior therapeutic area content expert within… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the safety risk assigned remains top of mind in the context of patient management in the clinical trial setting and in the real-world setting.Contributes ... CSPV and other internal groups) and outside of Daiichi Sankyo (eg clinical trial sites, CROs, collaboration partners); Supports effective direct communication… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and leads technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing ... laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some… more
- Eisai, Inc (Nutley, NJ)
- …pharmacokinetic (PBPK), quantitative system pharmacology (QSP) models, clinical trial simulations, literature meta-analysis, machine-learning/deep ... is driven to use cutting edge modeling approaches to advance the clinical and translational research in Neuroscience. This individual will provide scientific… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …years of experience with Supplier Management , Research Administration, Grant Operations, Grant Management , clinical trial management , or a similar ... (SOWs). The AD will be responsible for providing supplier management support and oversight to the North America CMR...GCP Principles and the application of those principles to trial design, planning & conduct of clinical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …decisions (phase I trials) Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator's Brochure ... Coast Development Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management , Biostatistics, Non-… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …decisions (phase I trials) Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator's Brochure ... Coast Development Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management , Biostatistics, Non-… more
- Novo Nordisk Inc. (Milwaukee, WI)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... ready to make a difference? The Position Builds relationships and demonstrates the clinical outcome and benefits of Novo Nordisk Inc., (NNI) products. Educates and… more
- Eisai, Inc (Baltimore, MD)
- …of MSLs in the region and works collaboratively with the Medical Affairs Senior management with strategic and tactical planning, working collaboratively with ... and other international regulatory/ethical guidelines relevant to the pharmaceutical industry & clinical trial conduct, and to ensure compliance with these… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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 ... across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions Serve as… more
- Amicus Therapeutics (Princeton, NJ)
- Senior Associate, Clinical Trial Manager (Contractor) Location Princeton, NJ Requisition ID 2292 # of openings 1 Apply Now ... (https://phh.tbe.taleo.net/phh04/ats/careers/v2/applyRequisition?org=AMICUS&cws=37&rid=1338) Senior Associate Clinical Trial Manager (Contractor) Amicus… more
- AbbVie (North Chicago, IL)
- …a framework required by the FDA for all clinical studies (PhIII) to improve clinical trial diversity. With this role, you will be an important member of the ... that enable equitable trial access and enhanced trial experiences. The Senior Manager within the...our understanding of disease disparities and the effects on clinical trial populations. This role will report… more
