- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …time, cost and quality deliverables. + Lead the development of the clinical study plan including critical path activities and interdependencies for assigned ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic...+ Lead the creation of the cross-functional Clinical Study Oversight Plan (CSOP) under the… more
- 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)
- …resolve or escalate to appropriate Governance Committee. Analyze CRO performance trends within a clinical study or across several studies and resolve or ... clin pharm patient studies , and Phases 1-3 clinical trials at the study and program...as programs or franchises. + When sitting on a study team, lead the study … more
- Bristol Myers Squibb (Madison, NJ)
- …members of the study team for the day-to-day oversight and conduction of the clinical studies included in the BOW for an asset in the Cell Therapy portfolio. ... manages the evidence generation for the CT portfolio (including Medical Affairs Sponsored studies [MAST]) and provides clinical support for other studies … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead , Product Safety Lead (PSL), Clinical ... lifecycle * Independently leads activities without supervision for assigned clinical studies * Lead activities... studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and review Statistical… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead , Product Safety Lead (PSL), Clinical ... lifecycle. + Independently leads activities without supervision for assigned clinical studies . + Lead activities... studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and review Statistical… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead , Product Safety Lead (PSL), Clinical ... lifecycle. + Independently leads activities without supervision for assigned clinical studies . + Lead activities... studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and review Statistical… 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 (Summit, 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …updates Study Supply Plans in close communication with CSO project Management Lead . + Responsible for the Clinical Label Development process which includes ... Legacy of Innovation 125 Years and Counting!** Daiichi Sankyo Group is dedicated to the creation and supply of...position is responsible for enabling the on-time delivery of clinical supplies across the DSI portfolio. This role is… 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)
- … 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
- 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
- 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
- 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
- Mount Sinai Health System (New York, NY)
- …per specifications of the protocol; and monitors test results, as appropriate Documents clinical study and therapy in patient's chart and all other databases ... provides clinical support and administrative direction for the Multiple Myeloma group within the Tisch Cancer Institute's Clinical Research Support Unit (TCI… more
- Sanofi Group (Morristown, NJ)
- **Job title** : Oncology HEVA Business Partner - Alphamedix Launch Lead **Location:** Cambridge, MA or Morristown, NJ **About the Job** Sanofi Specialty Care has ... the lives of patients. The US Health Economics and Value Assessment (HEVA) lead will be accountable for developing Health Economic and Outcomes Research (HEOR) plan… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …management, and provide safety leadership including but not limited to clinical studies , post-marketing surveillance, signal detection and management, important ... around rare diseases and immune disorders. **Summary** The Director, Clinical Safety, will be a product safety lead...the Global Product Team or specific sub-teams such as clinical study team and submission team, providing… more