- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. Summary The Director , Global Clinical Operations (GCO) Clinical Trial Operational Risk & Oversight ... 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)
- …areas centered around rare diseases and immune disorders. Summary The AD, Global Clinical Operations (GCO) Clinical Trial Operational Risk (CTOR), will ... Action/Preventive Action (CAPA) plans and related effectiveness measures, as appropriate.Responsibilities: Clinical Trial Operational Risk Management:Own, lead and… more
- Merck & Co. (North Wales, PA)
- …globe. Working with the Asset Development Team (ADT's), early- & late-stage clinical development teams, the Biomarker (BMx) leads will develop asset-specific ... clinical biomarker strategy by incorporating critical insight from discovery...with multiple functional line functions in various scientific and operational aspects of translational research and biomarker development.-Key responsibilities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.SummarySenior clinical operational leader accountable for operational planning and ... for clinical program planning and execution (from study design, operational planning, start-up, conduct, reporting, and close out) including timeline, quality,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …plan by function and team; Interprets and react accordingly to new preclinical/ clinical data(eg; Go/No Go decisions, reprioritization, etc.); Operational Project ... and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at ... trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study Team Leader for… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... investigational compounds in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of clinical … 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, ... - Leadership, Direction, and Strategy:Leads implementation of Therapeutic level clinical data collection requirements including cross-functional standards initiatives by… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of key drug development processes, plans, studies, and strategies including clinical , regulatory, scientific, operational , and commercial aspects of drug ... alignment with key global and regional functions. The Global Director of HEOR & RWE Oncology will lead the...key and visible expert leader, he/she will engage the clinical , Medical Affairs and commercial organization and drive the… more
- Merck & Co. (Durham, NC)
- …in the network of life-saving medicines and vaccines. - The Associate Director , Quality Systems and Compliance provides expertise in the coordination of resources ... expansion project. Adapts plans and priorities to address resource and operational challenges. Decisions are guided by policies, procedures and/or business plans.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... study team, external service providers (CROs, vendors, etc.) and clinical sites to ensure all trial deliverables are met...needs are met through alignment of business plans and operational need within the Therapy Area and in partnership… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Minimum 7 years' experience in life sciences, pharma with Clinical Trials Operational Data, Clinical Operational Metrics and Milestones. required4 or ... Indicators, Key Quality Indicators, Key Risk Indicators, and other targeted operational metrics in collaboration with R&D Line Functions. Candidate will establish… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …choices, drive core operations and develop insights to drive growth and operational excellence across the value chain while innovating for future capabilities. Our ... to maximize your potential with us? The Position The Director , CMR Insights Lead is responsible for leading the...drive organizational action, guide the Business units and the Clinical , Medical, and Regulatory Affairs (CMR) teams on strategy… more
- Merck & Co. (North Wales, PA)
- …with talented and dedicated colleagues while developing and expanding your career.The Clinical Director (Principal Scientist) has primary responsibility for the ... team. Our Company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the entire cycle of… more
- Merck & Co. (North Wales, PA)
- …strategy, including field standard operating procedures (SOPs), Good Clinical Practice (GCP) guidelines, and administrative/ operational ... to 50% travel required with some overnight.Role Summary The Regional Medical Scientific Director - GI Oncology is a credentialed (ie, PhD, PharmD, DNP, MD)… more
- Insmed Incorporated (Bridgewater, NJ)
- …high-quality, impactful customer engagements with a consistent approach worldwide. The FME Director will also drive operational excellence across the regions. ... Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director of Field Medical Excellence (FME) will develop field medical functional… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director of Biologics Potency in Analytical Research & Development is responsible for providing strategic and technical leadership for a portion ... talent development, and partnering to build a culture of innovation and inclusion.-The Director reports to the Executive Director , Cell Based Sciences and will… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …is primarily a tactical study delivery role, reporting into an Associate Director or above responsible for Operational Study Strategy. Responsibilities:Study ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions in...and site qualification with (study team and CRO).Contribute to operational delivery aspects of the protocol and take a… more
- Merck & Co. (North Wales, PA)
- …Our company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the entire cycle of ... clinical development strategies for investigational or marketed Oncology drugs;Planning clinical trials (design, operational plans, settings) based on these … more
- Insmed Incorporated (Bridgewater, NJ)
- …in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Senior Medical Director of Gene Therapy will develop, implement, and lead the gene therapy ... milestones in launch planningMedical leadership input for cross functional partners including clinical , operations, HEOR and commercial to ensure that there is a… more
