- 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
- 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
- Merck (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...entire Clinical Teams in the execution of clinical studies . + Will report and work… more
- Sanofi Group (Bridgewater, NJ)
- …safety, efficacy, and value of our products. + Lead the development of study protocols, statistical analysis plans, and clinical study reports. + Oversee ... as study management and publications. + Prior experience in clinical trials, RWE/Epidemiological studies including understanding of trial methodology,… 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
- Merck (Rahway, NJ)
- …the 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… more
- Merck (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; and +… 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
- Sanofi Group (Bridgewater, NJ)
- …phase 3b and phase IV clinical studies , including informing clinical development plans and study designs to ensure differentiating and relevant outcomes ... lead in patient and scientific knowledge to enhance clinical care. We curate patient and scientific evidence and...launch readiness. The role will bring in-depth knowledge of clinical studies , ensuring that medical plans and… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …the preparation/review of related key documents (ie protocols, Investigator's Brochures, clinical study reports, summaries for regulatory submissions). The ... the Clinical Development plan + Works with Clinical Supplies Group to ensure clinical...and direction to the review and finalization of Protocols, Clinical Study Reports and other relevant … more
- Sanofi Group (Morristown, NJ)
- …relevant statistical matters: + Provide high quality input into the design of the clinical study (including protocol development), the setup and conduct of the ... development. As Associate Statistical Project Leader, you will lead several oncology early phase projects or late phase...into interpretation and discussion of results sections for the clinical study report (CSR) and/or publications to… more
- Bristol Myers Squibb (Summit, NJ)
- …and registrational strategy + **Accountable for the** Clinical Pharmacology Plan + ** Lead ** design of clinical pharmacology studies and manages data ... clinical study design...cross-functional drug development teams, and regulatory submissions; serves as Clinical Pharmacology subject matter expert + ** Lead … more