- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Biopharmaceutics studies and model-based drug development plans, serves as QCP subteam leader / clinical pharmacology project team representative, supports ... support Phase 2/3 studies, represent function on study and project teams, and participate in and contribute to regulatory...and independently performs PK-PD analyses, functions as Study Team Leader for Phase 1 Clinical Pharmacology studies,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for all aspects of clinical pharmacology and biopharmaceutics studies; clinical pharmacology project lead ; supports Phase 2/3 ... of Clinical Pharmacology and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies, conduct hands on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …DSI portfolio. This role as CSO ( Clinical Supply Planning and Operations) Project Lead is primarily responsible for developing and updating Study Supply ... around rare diseases and immune disorders. Summary NOTE: This Project Lead Role is an Individual Contributor...updates Study Supply Plans in close communication with CSO project Management LeadResponsible for the Clinical Label… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Development in Project Teams, possibly as Global Clinical Lead . ResponsibilitiesStudy Strategy: Clinical study leader (CSL) or major ... to new preclinical/ clinical data(eg; Go/No Go decisions, reprioritization, etc.); Operational Project Team (OPT) leader ; Responsible before the IST for the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Development in Project Teams, possibly as Global Clinical Lead . Responsibilities:Study Strategy: Clinical study leader (CSL) or major ... to new preclinical/ clinical data(eg; Go/No Go decisions, reprioritization, etc.); Operational Project Team (OPT) leader ; Responsible before the IST for the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the ... 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)
- …as QCP representative on Clinical studies or take a lead on Clinical pharmacology studiesServe as QCP sub-team leader and represent the QCP function at ... setting, to drive the development of potential products and drug candidates. The Manager, Clinical Pharmacology will support or take the lead on generation of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Planning and Forecasting - Manages and is accountable for the development and control of Clinical Project Budget in support of Phase I-III clinical studies. ... Develops and maintains a working relationship with the internal project team(s) and team leader (s) or US...always maintained and accurate. Accountable to the Global Team Lead (GTL) and GPT (Global Project Team)… more
- Merck & Co. (Rahway, NJ)
- …benefit of patients and global human health. Responsibilities :Serves as a statistical lead in project teams. Lead , develops, coordinates, and provides ... biostatistical support for related drug/vaccine projects in Late Development Statistics. Lead the interaction with Clinical , Regulatory, Statistical Programming,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …employer including veterans and people with disabilities. SummaryThis position will be the Clinical Science Group Lead in late phase development in the Global ... the Senior Director level for each respective program. This Clinical Science (CS) Group Lead will be...trial protocols, review of clinical data and Clinical Study Reports (CSRs)/outputs throughout the project … more
- Merck & Co. (Boston, MA)
- Job DescriptionThe Executive Clinical Director (Distinguished Scientist) has primary responsibility for the strategic planning and directing clinical research ... compounds in Immunology. With a focus on late-stage development, the Executive Clinical Director will manage the entire cycle of clinical development,… more
- Merck & Co. (Rahway, NJ)
- …including those new to the organization therefore requiring someone who has built and lead clinical development plans from the ground up. They will also be ... Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Respiratory will focus on driving strategy, development, and life-cycle… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are ... Scientist) has primary responsibility for the planning and directing of clinical research activities involving new or marketed Oncology medicines. Our company… more
- Merck & Co. (North Wales, PA)
- …and statistical analysis methods fundamental to effective pharmaceutical R&D. The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment, ... and provide biostatistical support for related drug/vaccine projects in Clinical Safety StatisticsLead the interaction with Safety Physicians, Clinical… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Today, we are ... Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed oncology medicines. Our… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …operations clinical trial activities, ensuring adherence to timelines, budgets, project , and quality plans, and relevant ICH/GCP Guidelines Review protocols to ... rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all… more
- Merck & Co. (North Wales, PA)
- …and statistical analysis methods fundamental to effective pharmaceutical R&D.- The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment, ... statistical representative and core member in the Risk Management Safety Teams.- Lead and provide statistical support for related drug/vaccine projects in … 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 ... make a difference? The PositionThe Novo Nordisk Real World Evidence (RWE) / Clinical Data Science & Evidence (CDSE) - Fellow is responsible for supporting planning… more
- Aequor (Thousand Oaks, CA)
- Senior Project Manager - CMC Integration Project Management What you will do is searching for a Sr. Project Manager in our CMC Integration team within ... Operation Products Advancement in Process Development. The Sr. Project Manager (PM) will be responsible for integrating Process...Cycle Management and Commercial space working with the Operations Leader and the Product Delivery Team. The Sr. PM… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …treatment of multiple myeloma.Legend Biotech is seeking an Associate Director of Quality Project Management and Strategyas part of the Quality team based in Raritan, ... NJ. Role OverviewThe Associate Director of Quality Project Management and Strategy role is an exempt level...within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment.… more
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