- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Planning and Execution: Provides input on major milestones of trial , clinical trial plan and contingency planning ; Analyzes and updates management on ... submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to … more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Senior Director, GCTO Project Management Office will report to the Executive Director, Head of the GCTO Project Management Office (PMO). -You will ... Support strategic direction of the project management team, ensuring effective planning , execution, and delivery of projects across the portfolio. Stakeholder… more
- Merck & Co. (Rahway, NJ)
- …functional areas and GDMS on cross-functional trial teams and in other trial -level development forums.Under the guidance of more senior staff, may serve as ... Defines trial -level requirements for quality data collection and validation at the trial level.Reads and interprets the clinical protocol from a clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Dashboards. And in the R&D space including but not limited to clinical trial management system, drug labeling, and learning management system.Administration ... secondary point of contact of R&D areas including but not limited to clinical trial management system, drug labeling, and learning management system.Support… more
- Merck & Co. (North Wales, PA)
- …for the scientific aspects of the implementation and conduct of a clinical trial (eg, investigator meeting presentations, safety and medical monitoring)May ... serve as the CSSM scientific representative on the Clinical Trial Team (CTT)May work closely with...- Ability to manage multiple competing priorities with good planning , time management and prioritization skillsStrong analytical skills with… more
- George Washington University (Washington, DC)
- … research legal transactions including Confidentiality Agreements, Non-Disclosure Agreements, Clinical Trial Agreements, federally funded grants, contracts and ... Independently reviews, negotiates and drafts Confidentiality Agreements, Non-Disclosure Agreements, Clinical Trial Agreements, federally funded grants, contracts… more
- Eisai, Inc (Nutley, NJ)
- …strategic development, planning , implementation, and oversight of Phase IV clinical trial programs within the Medical Affairs department. She/He utilizes ... a difference. If this is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …into the Global Clinical Operations VP and is accountable for ensuring the clinical trial portfolio and submissions are delivered to time, quality, and cost. ... in scope/portfolio.Close collaboration with Asset and Portfolio Management (APM), GCO Clinical Trial Business Operations (CTBO), and GCO Study Optimization… more
- Merck & Co. (Rahway, NJ)
- …in meetings with investigators and regulatory agencies in discussions about clinical trial issues and submission strategies.Ensures the statistical designs ... Involved in research activities for innovative statistical methods and applications in clinical trial development. Education and Minimum Requirement: PhD or… more
- Merck & Co. (Rahway, NJ)
- …Lead research activities for innovative statistical methods and applications in clinical trial development. Collaborates in publication of research results ... development project as neededLead biostatistics in early or late clinical development planning to ensure that study...SAS and/or R.-Solid understanding of worldwide regulatory requirements and clinical trial expertise from phase II to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.SummarySenior clinical operational leader accountable for operational planning and ... 1-3 clinical trials at the study and program level. Responsible for clinical program planning and execution (from study design, operational planning ,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …CA Clinical Trial sites. Accountable for overall performance management of Senior Supply team, who contribute to the planning , execution and spend of ... GCP Principles and the application of those principles to trial design, planning & conduct of clinical trials Deep understanding of Distributor, Logistics… more
- George Washington University (Washington, DC)
- …of Public Health at the George Washington University is seeking a Senior Biostatistician to assist the department in conducting an NIH-funded prospective multi-site ... longitudinal cohort study, the DC Cohort. This study captures clinical information on persons with HIV receiving outpatient HIV care in Washington, DC, at 14 … more
- Aequor (Piscataway, NJ)
- …The S/MMC is expected to: Possess ability to understand and interpret clinical trial data, the literature and associated therapeutic conditions Coordinates ... Job Title: Manager/ Sr . Manager Medical Communications Hybrid schedule: West Chester.PA...Ability to establish and leverage relationships with external experts, clinical trial investigators, journal editors, and congress… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … processes for Brand planning and portfolio review- Provides input to Clinical on trial design, endpoints and comparators to support optimal price, access ... assets as assigned. This person will report to the Sr Director, Global Pricing & Access, and will be...reimbursement requirements for key markets are included in the clinical trial / evidence generation plans- Act… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …HEOR and RWE concepts and its impact on pricing & access preferred- Knowledge of clinical trial designs; sound understanding of clinical development & life ... regions/markets Ensure compliance with legal requirements- Collaborate and provides input to Clinical on trial design, endpoints, evidence generation plans, and… more
- Eisai, Inc (Nutley, NJ)
- …Provide strategic development, planning , implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for products ... for assigned therapeutic area. Under the direction of the Senior Medical Director, this role will be responsible for...update plans and inform stakeholders of progress. 30%Phase IV clinical studies: Direct and design strategies, planning … more
- Eisai, Inc (Nutley, NJ)
- …provides strategic development, planning , implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for products ... within ESI. Continuously update plans and inform stakeholders of progress.Phase IV Clinical Studies: Direct and design strategies, planning and implementation of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and field alignment directors. They will also be the senior strategic representative of medical affairs in the relevant...clear direction on Medical Affiars engagement needs to the clinical data science & evidence team and other relevant… more
- Merck & Co. (Rahway, NJ)
- …biopharma research, such as public Omics databases (eg, GenBank, GEO), clinical trial repositories (eg, ClinicalTrials.gov), patient-level data platforms (eg, ... to advance the drug discovery and development pipeline.We are seeking a Senior Information Architect with expertise in biopharma research to support our… more
