- 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
- 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
- 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 (Princeton, 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
- Takeda Pharmaceuticals (Trenton, NJ)
- …mission. **_GOALS:_** + Develop strategy for technology selection and deployment across Clinical Studies in alignment with established Takeda SOPs & Policies, ... are met with the highest degree of quality. + Lead study level technology & vendor oversight...in preparing function for submission readiness and may represent Clinical Trial Tools & Technologies (CT3) group … more
- Sanofi Group (Bridgewater, 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
- Bristol Myers Squibb (Princeton, 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
- 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 ... strategies. + The role will bring in-depth knowledge of clinical studies , ensuring that medical plans and... studies including observational, prospective, and claims database studies , and knowledge of study analyses plans… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …data cleaning and reconciliation efforts and work cross-functionally with all members of Clinical Study teams to foster an environment of quality and efficient ... integrating, execution, build and oversight of clinical trial deliverables. The Clinical Data Sciences group is responsible for integrating structured and… more
- Sanofi Group (Bridgewater, NJ)
- …contribution and/or approval of clinical development documents including clinical development plans, SAPs, study protocols, investigator brochures, data ... plans, study reports, integrated summary of safety, summary of clinical safety, and labeling + Review, preparation, and/or contribution to questions from… more
- Hackensack Meridian Health (Edison, NJ)
- …of chaplain interns enrolled in the organization's CPE Program. This includes case study reviews, small group relations, didactics, group supervision and ... to transform healthcare and serve as a leader of positive change. The Clinical Chaplain and Pastoral Care Educator provides compassionate pastoral ministry to all… more
- Sanofi Group (Bridgewater, NJ)
- …psychometric analyses; oversee interpretation and discussion of results supporting the clinical study report, regulatory discussions and/or publications. + ... a go-to person in digital biomarkers and provide technical guidance to other project/ study statisticians, stakeholders and junior staff. + Lead the provision of… more
- Sanofi Group (Bridgewater, NJ)
- …Leader (Director)** and you'll provide statistical leadership, guidance, and strategic input for clinical studies in one or more project teams. You'll have ... responsibilities:** + Expert level of statistical and scientific contribution to clinical development plans, studies , and submissions activities, and provide… more
- Sanofi Group (Bridgewater, NJ)
- …and will be responsible for medical affairs activities for phase IV studies and Life Cycle management activities. With guidance from the Head, Global ... indication; define and prioritize the future needs including new study ideas and tactics to prioritize the best areas...ideas and tactics to prioritize the best areas for clinical trial investment. + Collaborate with alliance partners at… more
- Sanofi Group (Bridgewater, NJ)
- …role you will** own and delivery new innovative Digital Products to support Sanofi's Study design powered by AI to accelerate cycle time and bring medicine to more ... R&D leaders to co-develop digital product strategies and roadmaps. + Lead cross-functional teams, including product owners, software engineers, data engineers, data… more
- Sanofi Group (Bridgewater, NJ)
- …a cross-functional team. + Ability to understand and effectively communicate vaccine clinical studies , both interventional and observational + Ability to analyze ... of company-sponsored clinical trials (ie, Ph 4 post-marketing and observational studies ) for new products that may join franchise portfolio in accordance with… more
- Sanofi Group (Bridgewater, NJ)
- …safety monitoring teams. **Job Summary** Provide leadership and guidance as the lead statistician dedicated to safety on one or more safety monitoring team(s), ... all methodological and statistical aspects for safety data analyses around pooled clinical trial data of project(s). Act as statistical consultant within company for… more