- Daiichi Sankyo, Inc. (Bernards, NJ)
- …-level timeline, cost, and quality deliverables. Lead the development of the clinical study plan including critical path activities and interdependencies for ... The incumbent will be responsible for ensuring execution of clinical studies across geographic regions, in adherence...equivalent. Lead the creation of the cross functional Clinical Study Oversight Plan (CSOP) under the… 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 ... with Clinical Scientists (CS)Interpretation and presentation of clinical study (ies) data to internal and external...and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of… 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 ... Join a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex ... a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of...rare diseases and immune disorders. Summary Position leads complex studies in study design, statistical analysis and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve ... to a strong portfolio of medicines for cardiovascular diseases, under the Group 's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex ... Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of... studies including study design, protocol development, CRF review, SAP development, analysis… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve ... to a strong portfolio of medicines for cardiovascular diseases, under the Group 's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …teams on various clinical projects and may function as the Lead Clinical Data Programmer on multiple projects simultaneously. ResponsibilitiesPerform all ... Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of...drug development processes and global submissions as required for clinical trials. These include developing and validating SAS programs… more
- Merck & Co. (Rahway, NJ)
- …activities of Clinical Scientists in the execution of clinical studies . Work closely with a cross-functional group of experts in commercialization, ... trials for investigational drugs Analyzing and summarizing the clinical findings from studies to support decisions...safety and efficacy as well as new drug applications, clinical study reports, or publication Participation in… more
- Merck & Co. (Rahway, NJ)
- …Director, PDT lead will manage the entire cycle of clinical development, including development strategy, study design, initiation, execution, monitoring, ... safety and efficacy as well as new drug applications, clinical study reports, or publications.Participation in internal...entire Clinical Teams in the execution of clinical studies .--Will report and work collaboratively with… more
- Merck & Co. (Rahway, NJ)
- …activities of Clinical Scientists in the execution of clinical studies . Work closely with a cross-functional group of experts in commercialization, ... support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in internal and joint… 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 ... Respiratory projects, including pipeline candidates and licensed productsSupervises development of clinical documents including protocols, clinical study … more
- Pfizer (New York, NY)
- …the way in healthcare and make a lasting impact on society. **What You Will Achieve** As a Clinical Study Group Lead , you will be an operational and ... 5 submission subteams and endgame inspection readiness. In the Clinical Study Group Lead... studies + Accountable to deliver excellence in clinical study team leadership for a portfolio… more
- Pfizer (New York, NY)
- …for patients. **What You Will Achieve** You will ensure that the clinical studies conducted in the Pfizer Biopharma Group are within time, budget and scope. ... You will help us plan and direct the clinical studies . You will create the timelines...level status reporting per organizational norms and expectations. + Lead the study team and associated deliverables… more
- Sanofi Group (Bridgewater, NJ)
- …and their families. Your skills could be critical in helping our teams accelerate progress. The Clinical Study Unit (CSU) is the site facing arm of clinical ... is responsible for monitoring and enrolling patients into our clinical studies here at Sanofi. The individual...Engagement Leads, Local Innovation Leads, and a Monitoring Team. Clinical Study Units (CSUs) are our experts… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …cost, and quality deliverables. + Lead the development of the clinical study plan including critical path activities and interdependencies for assigned ... The incumbent will be responsible for ensuring execution of clinical studies across geographic regions, in adherence... Lead the creation of the cross functional Clinical Study Oversight Plan (CSOP) under the… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …** Clinical Development Expertise Strategy:** + In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of ... Clinical Scientists (CS) + Interpretation and presentation of clinical study (ies) data to internal and external...and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of… more
- Bristol Myers Squibb (Princeton, NJ)
- … lifecycle ** Clinical Development Expertise & Strategy** + Designs and develops clinical studies and research plans in support of asset strategy with the ... new molecules, biomarkers, and mechanistic hypotheses in humans. The group drives early clinical strategy, and the...Early Clinical Development Leadership team; clinical … more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …as delegate of Therapeutic area (TA) Lead Clinical Scientist; Member of the Clinical Study Team and Global Clinical SubTeam + Line Manager for CS ... studies and ensures scientific integrity and interpretation of study data of a clinical development program....day may include the following:** + May function as lead Clinical Scientist (CS) for program, and/or… more
- Sanofi Group (Morristown, NJ)
- …datasets, medical imaging data, continuous data from wearable devices) collected from clinical studies for both formal reporting and exploratory analyses ... progress. The Statistical Biomarker Leader is involved in the clinical development process from early on to lead...concepts and techniques in various biomarker data collected in clinical studies + General knowledge of pharmaceutical… more
