- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and updates Study Supply Plans in close communication with CSO project Management Lead .Responsible for the Clinical Label Development process which includes ... 7 or More Years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development . preferredOncology experience… more
- Genmab (Plainsboro, NJ)
- …be responsible for oversight of a program of global studies, covering all clinical development deliverables.The role is hybrid and can be filled either in ... Development Operations.Provide input into the Clinical and Compound Development Plans developed by the CDT. Lead and coordinate cross functional … more
- Merck & Co. (Rahway, NJ)
- …s as the lead GCS spokesperson at clinical and development related meetings.- Working independently, the Program CSPM designs strategic and operational ... partner organizations ( as a lead GCS Planning program representative ) such as clinical development , regulatory, quality and other supply chain areas… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and ... 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …& Leadership:Has primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan ... and quality metrics and share with study team, Operations Program Lead , and Sr. Director for the...Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO, 3rd… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharm patient studies, and Phases 1-3 clinical trials at the study and program level. Responsible for clinical program planning and execution (from study ... and leads the successful execution of all operational components of a large-scale global clinical program using strong clinical project and program … more
- Genmab (Plainsboro, NJ)
- …across trials within a program , ensuring performance and competency development .Collaborate with Global Clinical Trial Managers (GCTMs) on trial activities ... management and budget planningProven performance in earlier role/comparable roleGlobal clinical program level experience requiredExperience within the field… more
- Merck & Co. (North Wales, PA)
- …clinical trials. Under the oversight of a clinical scientist, study manager, or program lead , the Clinical Specialist may be responsible for but not ... clinical trial objectivesCore Skills:Pharmaceutical, research, medical, and/or clinical drug development knowledge/experienceStrong communication, writing, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ... 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. (Rahway, NJ)
- …ensure full integration of the device development activities with the clinical , regulatory, formulation, commercial and other key Ofunctions. Lead the Device ... with applicable regulatory, quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device… more
- Formation Bio (New York, NY)
- …and collaborate with colleagues throughout the company, including our Medical/R&D, Biometrics, Clinical Program Management, and Clinical Operations teams to ... progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck...patients faster and more efficiently. About the PositionAs a Lead Product Manager, you will help execute on our… more
- Insmed Incorporated (San Diego, CA)
- … Teams and Global Asset Teams as needed.Be accountable for execution of program development from technical development , through manufacturing operations and ... They will collaborate with R&D and may assist with non- clinical biomarker quantification and testing efforts to ensure an...a subject-matter-expert for all HPLC and LC/MS based method development and testing.Participates as an Analytical Lead … more
- Merck & Co. (Rahway, NJ)
- …laboratory / regulatory documentation. Active strategic and technical leadership on program development teams, interfacing with key stakeholders, and ... development expertise with exposure to all stages and aspects of development (preclinical, clinical , and commercial) and cGMP industrial background.Capable of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …up-to-date on changes and related needs for patient support Develops recommendations and lead team to implements program changes to ensure ongoing compliance, ... reward hard work and dedication with opportunities for continuous learning and personal development . Are you ready to maximize your potential with us? The Position… more
- Genmab (Plainsboro, NJ)
- … strategy for assigned trials/compounds and participate in the development of the clinical development plan (CDP). Lead creation and review of ... Medical Director to be a part of our Global Clinical Development Team.The Medical Director will be...data, and medical input into regulatory documents and presentations.Responsibilities: Lead the development of the program… more
- Merck & Co. (Rahway, NJ)
- …Area and strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development .- The AVP provides strategic oversight for the early ... direction of clinical programs involving translational research and early clinical development for the Cardiovascular & Respiratory Therapeutic Area.- They… more
- Merck & Co. (Rahway, NJ)
- …execute, design verification strategies for assigned drug-device combination product program (s) for successful clinical introduction(s) and commercial market(s) ... plan, protocol(s), and report(s) that demonstrate design output(s) meet design input(s). Lead establishment of test methodologies, including method development … more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number ... technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or… more
- Merck & Co. (North Wales, PA)
- …and investigators essential to insight collection and participation in Our Company's clinical development programIdentify new and emerging science in areas ... the field medical leadership team, Headquarters (HQ) Medical Affairs teams, Global Clinical Development , and IIS teamsAssists Country Medical Affairs senior… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …function by collaborating with internal and external stakeholders to oversee the development and delivery of clinical data programming, reporting, data ... validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere… more
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