- Eisai, Inc (Nutley, NJ)
- …provide programming strategy in designing and developing programs in Eisai Clinical Computing Environment Implementation of new programs, enhancements & ... is your profile, we want to hear from you. The Associate Director, Clinical Programming must have expertise in addressing technical challenges in the programming… more
- Merck & Co. (Rahway, NJ)
- …any associated business systems needed to sustain on time and in full clinical supply to patients. implementation and maintenance of business insights and ... Job Description Position Overview - Basic Functions & Responsibility The Global Clinical Supply (GCS) organization, within our Research & Development Division, is… more
- Eisai, Inc (Nutley, NJ)
- …planning, study design/execution, and data monitoring to ensure successful implementation of high-quality clinical development programs.Lead and manage ... profile, we want to hear from you. The Director, Clinical Development is a newly created role for a...a newly created role for a dynamic individual with clinical leadership experience in the pharmaceutical industry. The position… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director is responsible for defining sourcing strategies for Clinical Innovative and Decentralized Services in support of our Company's ... clinical development pipeline. The role will need to interact...Procurement's SOPs.Responsibilities : Leadership : Accountable for development and implementation of robust sourcing strategies that link to core… more
- Eisai, Inc (Nutley, NJ)
- …Continuously drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies/ procedures across clinical ... your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality...you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for design, delivery… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. The Vice President/Head of Global Clinical Operations is a senior leadership role responsible for overseeing all aspects of ... clinical trial execution within a pharmaceutical or biotechnology company....processes in an industry setting.Proven track record of successful implementation of innovative strategies.Experience in managing and directing related… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and cultures.. Additionally, this position possesses advanced knowledge of clinical operations and relevant regulatory requirements. This position has advanced ... and risk managementResponsibilities: Leadership, Direction, and Strategy:In collaboration with Clinical Development and Clinical Operations as well as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …: The Manager, Data Management is accountable for end-to-end delivery of clinical data management services for assigned studies, collaborating with study teams, ... studies. This position requires a strong working knowledge of clinical data management processes, Electronic Data Capture (EDC)/related applications, industry… more
- Taiho Oncology (FL)
- …of clinical research. The Sr. Manager, Medical Field integrates clinical /scientific expertise and knowledge to ensure successful implementation of the ... Product/Therapeutic Area Support to External Stakeholders: Act as the primary clinical /scientific resource to HCPs in a specified geography for information… more
- Genmab (NJ)
- …Director, External Data Quality Management, is a strategic leadership role within Clinical Data Management. This individual is accountable for driving the strategy, ... quality, and integrity of external data across the clinical trial portfolio. This role serves as a Subject Matter Expert (SME) in protocol quality, central and local… more
- Aequor (Thousand Oaks, CA)
- … implementation of both new technologies, new processes.Job Description: Clinical Trial Delivery Operating Model: Develop Data Management playbook to encompass ... efficiencies and reduce hand offs. Collaborate with cross-functional teams ( clinical operations, site management, biostatistics, stats programming, TA) to optimize… more
- Legend Biotech USA, Inc. (Baton Rouge, LA)
- …team. Direct education for healthcare professionals treating oncology patients on clinical data, adverse event management, and mechanism of action for commercial ... Affairs strategies and tactics.Assist in the oversight of Legend Biotech sponsored clinical trial sites to include, but not limited to, site identification, patient… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …key stakeholders within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs.Facilitate operational meetings with ... re mediating PV system deficiencies cited in audit/inspections. Manage the implementation of effective corrective and preventative action PV Agreements and… more
- Merck & Co. (Rahway, NJ)
- …& Development team that designs and develops benchtop/low-volume to high-volume clinical and commercial assembly equipment and processes for medical devices/drug ... using semi-automated and automated equipment, conduct functional testing, assist in clinical batch manufacture as an equipment subject matter expert, assist with… more
- Eisai, Inc (Exton, PA)
- …new products in development through their lifecycle (Preclinical through phase III clinical development) at the Biologics Pilot Plant as well as supporting ... the Upstream and Downstream Operations groups to support the supply of DS/ADI for pre- clinical and phase I to phase III clinical studies, including the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …before and after CDx testing, for less complex projects.At the time of implementation of a CDx study/IVDR performance evaluation study integration of an assay into ... clinical testing (before testing) and once data is ready...to external diagnostic business partners specifically:Use of CTA/CDx within clinical trialsDevice protocols and SAPsDevice non-significant/significant risk determinations (both… more
- Eisai, Inc (Nutley, NJ)
- …components of overall medical operating plan. Provide strategic development, planning, implementation and oversight of Phase IV clinical trial programs ... management strategies in responsible therapeutic areas.Plan and implement Phase IV clinical development programs for assigned products. Create IIS strategies and… more
- Merck & Co. (South San Francisco, CA)
- …models, quantitative system pharmacology (QSP) and disease progression models, clinical trial simulations, comparator modeling) that seek to improve cycle ... time, cost/size and number of trials, implementation of tools and framework for driving Go/No Go decisions on programs and rapid regulatory approvalsFoster… more
- Eisai, Inc (Boston, MA)
- …exceed sales objectives. This will be accomplished by conveying complex clinical information to customers and key stakeholders regarding FDA-approved indications of ... to lead and contribute within a diverse teamDemonstration of a clinical aptitudeAn earned industry/market perspective coupled with high professional selling ability… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …cross-functionally with multiple functions and groups throughout the US organization, Clinical development, Research & Early Development, other affiliates, and the ... alignment between marketing, medical and market access Oversee development and implementation of data, diagnostics, drug, device, and precision health focused… more
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