- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. The Vice President/Head of Global Clinical Operations is a senior leadership role responsible for overseeing ... relationship management, and budget planning.Extensive experience in directing large/ global clinical trials teams across different stages of study in a… more
- Merck & Co. (North Wales, PA)
- …Degree in life sciences, preferred.Ideal candidate would have:Experience in conducting global clinical trials, including trial initiation through database ... Adaptability, Clinical Data, Clinical Operations, Clinical Outcomes, Clinical Research, Clinical Study Design, Clinical Testing, … more
- Merck & Co. (South San Francisco, CA)
- …of Phase I studies ; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, ... earliest stages of target identification and validation, and executing clinical studies to evaluate the relevance of...drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations)Provide clinical … more
- Merck & Co. (North Wales, PA)
- …and medical monitoring of clinical studies .Supervises development of clinical documents including protocols, clinical study reports and background ... Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Pediatrics will focus...of assets within the pediatric section of the Vaccine Clinical Development TA.May serve as a senior … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full c ... - Responsible and accountable for establishing the timelines for clinical supply needs per study and providing...analyses , and/or develops mitigation strategies for review with clinical partners and senior leaders.- - Works… more
- Genmab (NJ)
- …and execute territory plans in alignment with regional, national, and global Medical Affairs strategiesProvide insights/feedback on emerging scientific/ clinical ... diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and...RoleGenmab is currently seeking a Hematology Medical Science Liaison (MSL)/ Senior MSL (Sr. MSL) to be a part of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full ... and operational plans associated with the downstream activities of clinical supplies for their assigned studies . -The...Operations etc.) as well as other organizations such as Global Clinical Trial Operations (GCTO) Regional colleagues… more
- Merck & Co. (Rahway, NJ)
- …program development of novel statistical methodology.Analyzes data and interprets results from clinical trials to meet objectives of the study protocol.- ... to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.-Is responsible for planning and ensuring… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full ... effectively communicate with stakeholders at various levels, including cross-functional teams, senior management, external vendors, and clinical sites. Strong… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL) Study Planning and Execution: Provides ... medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams.Responsibilities: Study Strategy: Provides the… more
- Genmab (NJ)
- …and immunology experience preferredDemonstrated experience authoring protocols, investigator's brochures, and clinical study reports. Senior level candidates ... and editing of critical documents such as protocols, investigator's brochures, and clinical study reports.Contribute to Health Authority briefing documents and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …projects.At the time of implementation of a CDx study /IVDR performance evaluation study integration of an assay into clinical testing (before testing) and ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... other research areas centered around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the vision… more
- Merck & Co. (Rahway, NJ)
- …and programsIn collaboration with internal teams and external partners, designs studies , authors study protocols, develops measurement questionnaires, case ... work.-Develops American Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value DossiersDevelops supplementary clinical data package in close… more
- ACROBiosystems Inc. (New York, NY)
- …validation, candidate drug screening and optimization, CMC development, preclinical and clinical studies , commercial production, and companion diagnostics. We ... life science and healthcare industry. We value the fast growth in a global market over a challenging time by excelling through quality, performance, and innovation,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Director Global Medical Affairs Oncology (GMA), under the direction of the Senior Director, GMA Oncology ( Global Medical Affairs team lead for compound), is ... indications.- Support as medical lead for select company-sponsored GMA evidence generating studies /projects. Manages all medical aspects such as study document… more
- Merck & Co. (North Wales, PA)
- …and programs.In collaboration with internal teams and external partners, designs studies ; authors study protocols; and develops measurement questionnaires, case ... work.Develops American Managed Care Pharmacy (AMCP) dossiers for US payers and Global Value Dossiers.Develops supplementary clinical data package in close… more
- Eisai, Inc (Nutley, NJ)
- …capacity. Practical knowledge of FDA regulations/ICH guidelines regarding conduct of clinical studies in relevant therapeutic area. Substantial experience across ... and supportive tactics for assigned therapeutic area. Under the direction of the Senior Medical Director, this role will be responsible for working with key… more
- Merck & Co. (North Wales, PA)
- …and others.To prepare outcomes research protocols, statistical analysis plans, and clinical study reports.To ensure findings are communicated effectively at ... opportunities.To inform and contribute to the value evidence plan and associated studies which demonstrate clinical , economic, and patient-centered value. The… more
- Merck & Co. (North Wales, PA)
- …with the Investigator Study Program Committee to evaluate outcomes research study protocols for studies in local markets.Supports affiliates to understand ... and gain input on research design and implementation of retrospective database studies , assessment of patient reported outcomes, epidemiological studies and… more
