- Eisai, Inc (Nutley, NJ)
- …related to CSR appendices. Act as central point of contact for the clinical team for designated projects, communications, and associated documentation Document ... and close-out) under the direction and supervision by study Clinical Operations Lead (s). Plans, support, creates, and...team produce deliverables on schedule. Ensures consistency of clinical study and processes across clinical trials.… more
- Merck & Co. (Rahway, NJ)
- …Good Laboratory Practice (GLP) studies.The Associate Principal Scientist is the primary clinical study team leader and has overall responsibility ... etc.) and keeps them informed of the study progress.May be the Global Clinical Research (GCR) representative in the project team . Assume responsibility for… more
- Eisai, Inc (Nutley, NJ)
- …team of Clinical Operations staff to oversee all aspects of clinical trial development. Lead clinical study inspections from preparation through ... vendors, to ensure successful execution of clinical studies.Build and mentor a ...presence.Invest in the development of future skills within the clinical operations team , providing feedback, coaching, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders.SummaryThe Director, Clinical Safety, will be a product safety lead or part of a product safety team , and be responsible for ... function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory,...Depending on the status of development of the compound, lead and medical-scientifically direct a team of… more
- Eisai, Inc (Nutley, NJ)
- … studies.Job SummaryThe Associate Director, GCP Quality Assurance works within the Global Clinical Quality team to conduct GCP compliance activities at Eisai, at ... relationships with internal and external stakeholders and be the Lead Quality Assurance representative to clinical teams...be the Lead Quality Assurance representative to clinical teams on assigned trials. This is a high… more
- Legend Biotech USA, Inc. (Minneapolis, MN)
- …displays as required.Actively participate in journal clubs, book clubs, and team clinical discussions.In collaboration with supervisor develops, implements, and ... Clinical Educator, Midwest as part of the Commercial team .Role OverviewThe Sr. Cell Therapy Clinical Educator...management.The Sr. CTCE will serve as the strategic education leader across oncology accounts in a defined geographic area.… more
- Merck & Co. (Boston, MA)
- …Scientist) has primary responsibility for the planning and directing of clinical research activities involving new or marketed medicines in the Atherosclerosis ... The Executive Director will manage and oversee the entire cycle of late stage clinical development from Phase 2 to Phase V, including development of program strategy… more
- Merck & Co. (Rahway, NJ)
- …to customers both internal and external to GCS and serves as the lead GCS spokesperson at clinical and development related meetings.- Working independently, ... limited to:--Interacts closely with key partner organizations (as a lead GCS Planning program representative) such as clinical...clinical supply planning and incorporate them into the team 's operations. - Focus on Customers & Patients. -… more
- Genmab (NJ)
- …and consistency across programs and systems. This role reports to the Director, Team Lead of Clinical Programming.Responsibilities/tasks - including but not ... fit? Then we would love to have you join us!The Programming Manager, Clinical Programming is responsible for ensuring integrity, consistency and adherence to Study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …TLFs to support submission QAs, perform ad-hoc and exploratory analysis requested by clinical team , and support agency response or potential Advisory Committee ... build up standard on SDTM/ADaM datasets, and TFLs.Responsibilities:- Supporting project lead on outsourced projects, act as statistical programming subject matter… more
- Merck & Co. (Boston, MA)
- … Team VP will manage individuals who lead multi-tumor asset teams (asset team leads). Any clinical development staff reporting to the ATL will be indirect ... cross-Tumor Team execution and successful approval of the product.Ensures clinical programs and clinical studies are designed and monitored optimally.… more
- Merck & Co. (Rahway, NJ)
- …results aligned with enterprise goalsDevelop an incoming and release testing strategy, lead siting discussions for clinical and commercial testing, and develop ... Associate Principal Scientist to serve as a Device Analytical Lead supporting medical device and combination product (MDCP) programs...all analytical activities to support on time release of clinical suppliesWork with the validation team on… more
- Merck & Co. (Rahway, NJ)
- …candidates from development to launch in line with enterprise priorities.-As the DCT leader , the Technical Product Leader (TPL) in our Manufacturing Division ... target commercial product.-Leads the cross-functional DCT, critically assessing all team deliverables & fostering a learning and collaborative environment.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: Senior clinical operational leader accountable for operational planning and execution of ... FIH, clin pharm patient studies, and Phases 1-3 clinical trials at the study and program level. Responsible...well as programs or franchises.When sitting on a study team , lead the study team … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with ... biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL)Study Planning and Execution: Provides input on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution ... lead the development and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of the other sections in… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Description The Development and Commercialization Team (DCT) leader is-accountable for delivering a fully-integrated stage-appropriate CMC ... advancing the company's Antibody Drug Conjugate (ADC) portfolio. Correspondingly, the DCT leader will be responsible for delivering world class outcomes in the… more
- Merck & Co. (San Francisco, CA)
- …following responsibilities: Design and implement biomarker strategies for early and late-stage clinical programs. - Lead clinical biomarker sub-teams as part ... Job DescriptionAssociate Principal Scientist, General Medicine Therapeutic Areas Biomarker Lead Job DescriptionTranslational Biomarkers (TB) is responsible for the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Product Evolution o Establish product strategy and regulatory activities related to new clinical data or label changes. Lead modification to marketing strategies ... market needs and critical success criteria are addressed ie clinical development programs, data generation needs, international guidelines, required...the priorities of the business o Recruit, build and lead a highly effective marketing team o… more
- Genmab (NJ)
- …of the external environment may impact their area of responsibility. People manager: Lead a small/ local team to ensure oversight of deliverables, development ... to have you join us!The Role & DepartmentThe Feasibility Lead supports the vision and strategy set forth by...final feasibility. KPIs developed and shared across the study team as part of year end objectives.Point of contact… more
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