- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Director , Global Clinical Trial Operations (GCTO) Project Management Office (REMOTE) The core responsibility of this ... independently direct the execution and coordination of major change projects across Global Clinical Trial Operations (GCTO). The role will also contribute to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary The Director , Global Clinical Operations (GCO) Clinical Trial Operational Risk & Oversight (CTOR&O), ... and continuously monitored for effectiveness, efficiencies, and areas of improvement.Responsibilities: Clinical Trial Operational Risk (CTOR) Management:Build and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. SummaryThis new role is within R&D reporting into Global Clinical Operations (GCO) and the fundamental responsibility is dedicated ... into consideration the epidemiology of the disease -Review applicable study specific clinical trial materials to ensure cultural sensitivity and health literacy… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. Summary The AD, Global Clinical Operations (GCO) Clinical Trial Operational Risk (CTOR), will be ... Action/Preventive Action (CAPA) plans and related effectiveness measures, as appropriate.Responsibilities: Clinical Trial Operational Risk Management:Own, lead and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulations and the WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates ... participates in the strategic planning for future change. Subject matter expert on global clinical trial registration, result posting, plain language… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the… more
- Merck & Co. (North Wales, PA)
- …including clinical directors and study managers to lead/support clinical trial scientific-activities.Job ResponsibilitiesResponsible for the clinical ... /scientific execution of clinical protocol(s).Serves as the lead clinical scientist on the clinical trial team.Collaborates with the Medical Writer on … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …meetings Serve on Clinical Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director , and Field Medical Affairs point to ... for select clinical trials, in collaboration with Clinical Director and Clinical Operations...Medical Affairs team on relevant disease state topics and clinical trial data. Review and approve resources… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …economic models, and Global Value Dossiers- Propose and implement analysis of clinical trial data for cost effectiveness models and market specific ad-hoc ... with key global and regional functions. The Global Director of HEOR & RWE Oncology...key and visible expert leader, he/she will engage the clinical , Medical Affairs and commercial organization and drive the… more
- Merck & Co. (Rahway, NJ)
- …Asset Development Teams, Early Development Teams; Product Development Teams, Clinical Trial Teams, Discovery, Informatics; Diagnostics, quantitative modeling ... 2 years experience in pharma or similar industry setting.Required:Must have experience in clinical trial development and execution; clear strategic view on the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead. ResponsibilitiesStudy Strategy: Clinical study leader (CSL) ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...Phase 2 studies: Provides input on major milestones of trial , clinical trial plan and… more
- Insmed Incorporated (San Diego, CA)
- …a Sponsor company.Experience managing various phases of clinical trials.Experience in global clinical trial conduct across several therapeutic areas is ... Company DescriptionAbout Insmed Insmed is a global biopharmaceutical company on a mission to transform...systems, practices, and procedures to ensure efficient and effective clinical trial execution including data management and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Drives and leads the successful execution of all operational components of a large-scale global clinical program using strong clinical project and program ... of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , Clinical … more
- Catalent (MA)
- …robust network built around flexible and integrated service offerings for pharmaceuticals in clinical trial phases I-IV. We provide reliable service and deep ... Job DescriptionAccount Director , Clinical Development & Supply With...Job DescriptionAccount Director , Clinical Development & Supply With ten facilities in...expertise in global supply chain and clinical supply management… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal and external partners, identify, qualify, manage, and maintain relations with clinical trial sites, including collaboration with PIs and patient ... advanced degree is preferred A minimum of 12 years' progressively responsible clinical trial experience within a pharmaceutical, biotechnology, CRO and/or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for the development, ... pipeline.Proactively identify Data Standards gaps and resolve issues related to clinical data standards development throughout the trial lifecycle.Standardize… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …more clinical stage assets (including those at the pre-IND stage) within the Global Clinical Science function. This position may be at the executive ... science perspective, and ensure the writing of high quality clinical trial protocols, review of clinical...and safety monitoring under direct guidance of a physician ( Global Clinical Leader or Physician Scientist). The… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …be the Clinical Science Group Lead in late phase development in the Global Clinical Science function. He/she will be responsible for managing the multiple ... Group Lead will also ensure the writing of high-quality clinical trial protocols, review of clinical...in Clinical Development, Asset & Portfolio Management, Global Clinical Operations, BDM and DLT members.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, ... a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This...The Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …that Payer and KOL reimbursement requirements for key markets are included in the clinical trial / evidence generation plans- Act as an ambassador to drive ... areas centered around rare diseases and immune disorders. SummaryThe Director , Global Oncology Pricing & Access will...for Brand planning and portfolio review- Provides input to Clinical on trial design, endpoints and comparators… more
