- 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)
- …of vendor budget and activitieso Oversee the quality and timeline of vendor worko Coordinate study clinical or medical lead and biostats input to ensure ... Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of...Medical Affairs Oncology Publications works with GMA Oncology Publications Lead , to support development of publication plans, drive the… 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
- Pfizer (Pearl River, 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
- 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
- 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
- Gilead Sciences, Inc. (Parsippany, NJ)
- …(ICH) guidelines and Good Clinical Practice (GCP) governing the conduct of clinical studies . + Proven ability and experience to effectively execute ... Operations leader for a Director position within our Oncology Group . Clinical Operations is responsible for the...to support a fluid 'One Ops' workforce. You will lead and/or effectively engage in Clinical Operations,… 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
- Bristol Myers Squibb (Madison, NJ)
- …training Clinical Development Expertise & Strategy + In collaboration with the Clinical Development Lead , designs and develops clinical plans and ... targets + Provides oversight and medical accountability for a group of studies + Leads the analysis...reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study… more
- Pfizer (New York, NY)
- …Intake processes to optimize efficiency and compliance with regulatory requirements. + Lead and manageaudits within the Study Organization (SO), including ... (R&D) engine providing analytics & intelligence to customers and stakeholders across clinical and regulatory functions within PRD & POD. The Site Intelligence,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Develops biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL) + Study Planning and Execution: ... Legacy of Innovation 110 Years and Counting!** Daiichi Sankyo Group is dedicated to the creation and supply of...and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. Responsibilities + Study… more
- Sanofi Group (Morristown, NJ)
- …key external stakeholders. + Ability to understand and effectively communicate vaccine clinical studies , both interventional and observational + Knowledge of ... clinical trials (ie, Ph 4 post-marketing and observational studies ) for new products that may join franchise portfolio...and ESC applications + Liaise with the investigators of study applications. + Present studies to the… more
