- Sanofi Group (Morristown, NJ)
- …results + Comply with company standards & local regulations Design and Oversee Clinical Studies + Be the strategic lead in the development of clinical ... oversight and approval of the protocol, Key Results Memo, Clinical Study Report and for other ...medical input & support for all activities related to clinical studies such as medical training, feasibility,… 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
- 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 to and… 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
- Sanofi Group (Morristown, NJ)
- … Programs** - Serve as the medical lead for switch programs and clinical studies (eg, Actual Use Trials), ensuring compliance with clinical , regulatory, ... **Global Switch Medical Strategy Lead ** + _Location: Morristown, NJ /Hybrid_ **_About the...understanding of technical requirements for switch. Proven experience in clinical and consumer behavior studies for switches… 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …sections of submission documents under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates as team member with ... Legacy of Innovation 125 Years and Counting!** Daiichi Sankyo Group is dedicated to the creation and supply of...the CSL and Medical Monitor in the execution of Clinical Development functions. **Responsibilities** + Study Strategy:… 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; 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: ... Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. **Responsibilities** + Study Strategy:… more
- Sanofi Group (Morristown, NJ)
- …could be critical in helping our teams accelerate progress. Join our Global Switch group as Global Switch Science Lead (Innovation) where you will be responsible ... **Global Switch Science Lead (Innovation)** + _Location: Morristown, NJ (Hybrid)_ **_About...success in navigating global or regional regulatory environments. + ** Clinical and Consumer Studies ** : Experience conducting… 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
- Mitsubishi Chemical Group (Jersey City, NJ)
- …Director of the Medical Science Early-Stage, the Director, MSES will lead clinical and scientific aspects of Early Development studies from Phase 0 through ... for successful execution, analysis, interpretation of results of early-stage clinical studies . + Leads or participates in...+ Prepares and/or directs the preparation and review of study protocols, clinical study reports… 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
- Sanofi Group (Morristown, NJ)
- …ensuring compliance with local regulations. + **Switch Product Expertise** - Experience in clinical and consumer studies relevant to switch programs, with a ... **Global Switch Science Lead (ACNU)** + _Location: Morristown, NJ/Hybrid_ **_About the...our teams accelerate progress. Join our Global Switch Science Lead where you will be responsible for leading the… more
- IQVIA (Parsippany, NJ)
- …is a must-have, as well as developed analytic skills. Key collaborators are the Clinical Lead for site management, the Project Vendor Manager, the Project ... This is a remote/home based position. We are looking for Senior Project Leaders/ Clinical Program Managers to join our innovative and dynamic group of global… 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