- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Data Management globally and ensures execution of the global data management strategy across regions and across studies /programs.- Represents Data ... research areas centered around rare diseases and immune disorders. Summary The Executive Director, Data Management (Head of Global Data Management) sets the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of an environment that inspires, motivates, and empowers colleagues.Accountable to lead delivery of enterprise activities within study activation activities ... immune disorders. Job Summary: The GCO Senior Director of Study Optimization has accountability for the oversight, management, and...experience ideally including time in role such as a Global Project Leader at Sr. Director level… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Daiichi Sankyo's quality measures. Analyze CRO performance trends within a clinical study or across several studies and resolve or escalate accordingly.Support ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …activities related to evidence generation, scientific engagement and communication- Serves as Global Medical Affairs Team (GMAT) Lead , to gain strategic and ... centered around rare diseases and immune disorders. SummaryMedical Affairs leader for the portfolio of early asset compounds under...medical review of expanded access programs (EAP) and, investigator-initiated studies (IIS) as part of a Global … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Serve as medical lead for select company-sponsored GMA evidence generating studies /projects. Manages all medical aspects such as study document development ... of investigator-initiated studies (IIS) and may serve as deputy compound lead in Global IIS Review Committee meetings.- Leads external medical education… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … global projects with high impact with ability to lead and project-manage cross-functionally and globally with business stakeholders is highly-preferredMust ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... areas centered around rare diseases and immune disorders. SummaryUS Medical Affairs leader for assigned compound under the supervision and leadership of the… more
- Eisai, Inc (Nutley, NJ)
- …the scientific expertise, the incumbent must be capable of analyzing and interpreting study data and effectively communicating findings to a broad audience. The ... data .Serves as Medical Monitor (where applicable) to review and monitor study data .Implements strategies to identify, monitor and resolve clinical… more
- Eisai, Inc (Nutley, NJ)
- …development and the communication of clinical, real-world, health economics outcomes data . This role primarily focuses on late-stage pipeline and marketed products, ... and appropriate utilization based on generation and communication of quality data . Essential Functions Educate population-based decision makers on health economic… more
- Eisai, Inc (Nutley, NJ)
- …of that plan.Champion CQA's mission of 'Quality as enabler of business'; lead global initiatives for continuous improvement.Trend and leverage internal audit ... the workforce to evolving technologies.Align clinical portfolio, business strategy, clinical studies , and related functions eg data management, clinical… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** AI-Enabled Global Study Data Leader **Location:** Morristown, NJ Cambridge, MA **About the Job** Are you ready to shape the future of ... We are seeking a highly motivated and experienced AI-Enabled Global Study Data Leader...etc.) + Works with cross-functional teams, including medical leads, global study lead , statisticians, clinical… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Global Study Data Leader **Location:** Morristown, NJ Cambridge, MA **About the Job** Are you ready to shape the future of medicine? The ... families. Your skills could be critical in helping our teams accelerate progress. Global Study Data Leader is responsible for leading the end-to-end… more
- Sanofi Group (Morristown, NJ)
- …our teams accelerate progress. Join our Clinical Science Organization as an **AI-Enabled Global Study Leader ** and you'll drive digital transformation across ... started? **Main Responsibilities** + Lead the cross-functional study team and oversee global study... study team and oversee global study processes including protocol development, enrollment, data … more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA/ Waltham, MA/ Morristown, NJ **About the Job** Are you ready to shape the future ... information can be found through the LINK (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) . Global Terms & Conditions and Data Privacy… more
- Sanofi Group (Morristown, NJ)
- …clinical studies , considering clinically relevant, patient-centric outcomes + Lead Medical responsibilities within Global Labelling process for hemophilia ... **Job title** : Global Medical Lead Hemophilia **Location:** Cambridge, MA / Morristown, NJ **About the job** The role reports to the Global Head of… more
- Sanofi Group (Morristown, NJ)
- …found through the LINK (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) . Global Terms & Conditions and ... Data Privacy Statement (https://www.sanofi.com/en/careers/ global -terms-and-conditions/) Sanofi is dedicated to supporting people through their health challenges.… more
- Sanofi Group (Morristown, NJ)
- …approval of clinical development documents including clinical development plans, SAPs, study protocols, investigator brochures, data monitoring plans, study ... analysis strategies to further define the safety profile. + Lead aggregate safety data review activities and...+ For products under clinical development: Clinical Development Plan, study protocol, Statistical Analysis Plan, data monitoring… more
- Sanofi Group (Morristown, NJ)
- … Simultaneous Submissions (GSS), they partner in an agile model with the Submission Lead and global colleagues to provide regional expertise and execute the ... information can be found through the LINK (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) . Global Terms & Conditions and Data Privacy… more
- Sanofi Group (Morristown, NJ)
- …scientific exchange) to understand the evolving PN medical landscape and optimize the Global Medical strategy + Lead the development and execution of symposia ... information can be found through the LINK (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) . Global Terms & Conditions and Data Privacy… more
- Sanofi Group (Morristown, NJ)
- …approval of clinical development documents including clinical development plans, SAPs, study protocols, investigator brochures, data monitoring plans, study ... analysis strategies to further define the safety as well as Benefit Risk profile. + Lead the review of aggregate safety data and related activities as well as… more
