- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …the operational strategy for delivery of one or more complex programs in Clinical Trial Management (CTM). This individual is responsible for clinical ... assigned program(s). The POL is a member of the Clinical Trial Management extended leadership team, and...Trial Management in partnership with Functional leadership. The Director POL is expected to operate with autonomy and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** The Clinical Trial Information Disclosure Manager leads company operational activities to comply ... IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee....drafting, as appropriate. + If necessary, substitutes for the Director at trial disclosure related meetings. +… more
- Vitalief (New Brunswick, NJ)
- Overview Vitalief is a pioneering, "best of breed" Research and Clinical Trial Solutions Consulting Company. We are seeking a problem-solving oriented, ... member of our exceptional Client Services Delivery team. The Director will work closely with senior management and our...while balancing costs and quality. + Responsible for enhancing clinical trial execution and enrollment through building… more
- Merck (Rahway, NJ)
- …and therapeutic expertise for the design, planning and execution of early phase clinical trials with the Clinical Director and internal/external team ... design, data or study conduct issues. Reviews and interprets clinical trial data. May conduct on-site study...are completed in accordance with applicable standards. Develops study operational documents with input from team members (eg site… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …and implements innovative solutions to resolve roadblocks in patient recruitment and clinical trial execution via development of an overall outsourcing strategy ... in vendor management, leading CROs/various contracted resources, site monitoring and clinical quality compliance, andmanaging clinical trial budgets… more
- Bristol Myers Squibb (Madison, NJ)
- …Global Data Management (GDM) **Functional Area Description** GDM is responsible for clinical trial data acquisition, data management and review, and medical ... **Key Competency Requirements** + Expert understanding of the drug development process and clinical trial execution. + Expert knowledge of industry trends and… more
- Sanofi Group (Bridgewater, NJ)
- …operations teams + Implements strategies to identify, monitor and resolve clinical program/ trial issues. + Serves as the Study Director and Medical Monitor ... you thought was possible. Ready to get started? The Clinical Research Director (CRD) is the primary...and briefing packages for Regulatory agencies, extended synopsis/protocol for clinical trials, Investigator Brochure, Clinical Trial… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …protocols and statistical analysis plans (SAPs). + Oversees the strategy and support of operational aspects of I&I clinical trial execution, data management ... on real-world evidence, and creating hope for all facing illness. The Director , Clinical Science (I&I) will lead the early- to late-stage development team(s) in… more
- Pfizer (New York, NY)
- …plans. Data generated by epidemiological studies is critical evidence needed to support clinical development (planning for Phase 3 efficacy trial , including a ... of the program(s). + Using expert knowledge of epidemiologic and vaccine clinical trials, provides oversight of operational strategic partner involvement at… more
- Sanofi Group (Bridgewater, NJ)
- …stretch the limits of what you thought was possible. Ready to get started? The Senior Clinical Research Director (SCRD) is an **expert clinical lead for one ... LCM program + Develop the regulatory documentation for the project(s), provide clinical leadership to other operational development activities pertaining to… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …execution: As CSL for Phase 2 studies: Provides input on major milestones of trial , clinical trial plan and contingency planning, Analyzes, updates ... plan by function and team; Interprets and react accordingly to new preclinical/ clinical data(eg; Go/No Go decisions, reprioritization, etc.); Operational Project… 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, ... + Proactively identify Data Standards gaps and resolve issues related to clinical data standards development throughout the trial lifecycle. + Standardize… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …and delivery of the operational strategy of one or more programs in Clinical Trial Management (CTM). This individual is responsible for clinical ... assigned program(s). The POL is a member of the Clinical Trial Management extended leadership team, and...+ Oversee clinical study timelines within a clinical program(s) + Provide input and operational … more
- Teva Pharmaceuticals (Parsippany, NJ)
- …demonstrating leadership qualities, creative and strategic thinking and knowledge of cutting-edge clinical trial design and methodology. He or she must have ... clinical development and Global Statistics through the use of novel/innovative clinical trial designs and statistical methodology + Makes decisions regarding… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- … protocols and statistical analysis plans (SAPs). + Oversee planning and support operational aspects of clinical trial execution, data management and ... Director , MSLS will be responsible for MSLS strategy, clinical program oversight, and support of clinical ...clinical development experience, with a strong background in clinical trial design and execution + Proven… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …following the directives provided by the GDO. + Support flawless implementation and operational aspects of clinical trial execution, data management and ... As a senior member of Medical Science, the Senior Director , Medical Science - Early Stage will lead the...including a strong background in rare disease development and clinical trial design including pediatric programs. +… more
- AbbVie (Florham Park, NJ)
- …submitted to the regulatory authorities. + Participate in the design and execution of clinical trial safety, product safety and risk management plans. May also ... and LinkedIn. Job Description Provides medical, scientific, strategic and operational leadership and expertise into core medical affairs activities...+ Minimum of 2 years of medical affairs and/or clinical trial or clinical practice… more
- Pfizer (New York, NY)
- …activities across partner lines. + Expert knowledge, experience and expertise in clinical trial development, and operational quality management disciplines ... quality issues and risk areas within assets and across clinical trial programs. In partnership with the...contributor role + This role reports into the Sr. Director + Last date to apply is July 9,… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …on risk management efforts by identifying and mitigating non-compliance risks across clinical trial vendors and working alongside quality assurance for regular ... We are looking for a Director Global Procurement-R&D- Inspection Readiness to be responsible...management efforts by identifying and mitigating non-compliance risks across clinical trial vendors and working alongside quality… 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 ... of key drug development processes, plans, studies, and strategies including clinical , regulatory, scientific, operational , and commercial aspects of drug… more