- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilitiesSummaryThe Associate Director , Global Oncology Clinical Development (GOCD) Functional ... (checklist, process map, etc.), change management and detailed analysesThe Associate Director , GOCD Functional Excellence must have excellent verbal and written… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , Clinical Project & Planning Management is a member of ... the Clinical Business Operations team within Development Operations and provides...travelSalary RangeInsmed takes into consideration a combination of candidate's education , training, and experience as well as the position's… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. SummaryThis new role is within R&D reporting into Global Clinical Operations (GCO) and the fundamental responsibility is dedicated to GCO. This ... the successful delivery of study diversity plans in adherence with Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; ... of key submission documents; Point of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , Clinical ... research areas centered around rare diseases and immune disorders.SummarySenior clinical operational leader accountable for operational planning and execution of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Director , Global Clinical Operations (GCO) Clinical Trial Operational ... and continuously monitored for effectiveness, efficiencies, and areas of improvement.Responsibilities: Clinical Trial Operational Risk (CTOR) Management:Build and manage GCO… 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 be ... Action/Preventive Action (CAPA) plans and related effectiveness measures, as appropriate.Responsibilities: Clinical Trial Operational Risk Management:Own, lead and manage GCO… more
- Insmed Incorporated (San Diego, CA)
- …lists.OverviewThe primary responsibilities are to manage all aspects of clinical operations including study planning, financial oversight, project deadlines and ... ensuring compliance with Good Clinical Practices as well as federal and local laws.ResponsibilitiesAdditional representative responsibilities will include, but not… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle...percent of the time to manage future or ongoing clinical research projects. Qualifications Education MD, DO,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders.SummaryThis position serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple ... surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s), and cross-functional team in support of benefit risk… 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)
- …head of regulated bioanalysis will also form strategic internal (DMPRL, Clinical Operations, Data Management, Scientific Operations etc) and external partnerships to ... position has extensive knowledge of regulated BA, DMPK, biological sciences, clinical pharmacology, BA strategic planning, regulatory guidance, and in-licensing and… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director of Clinical Pharmacology role within Clinical Development ... organization will provide leadership and expertise to support assigned clinical pharmacology projects in the clinical development programs for an expanding… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewTheDirector, Clinical Development will play an important role in working with the ... team to execute the global clinical development plans of brensocatib for the HSindication. Tasks...requirementsSalary RangeInsmed takes into consideration a combination of candidate's education , training, and experience as well as the position's… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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 ... and immune disorders.SummaryThe incumbent will be responsible for ensuring execution of clinical studies across geographic regions, in adherence to Good Clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) Group Lead ... centers globally in partnership with other cross-functional leaders- Contribute to Clinical Development initiatives, global education , and process development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Associate Director will be responsible for developing and implementing Clinical Pharmacology and Modeling & Simulation plans from FIH to post registration. ... Responsibilities include the development of Clinical Pharmacology and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)- Bachelor's Degree In ... Healthcare Related Field required- PharmD preferred- PhD preferred Experience Qualifications- Must have 4 or more years of professional experience related to risk management planning, risk management sciences, and risk management tools and resources… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; ... Represents clinical function at meetings with health authorities; Oversees management...meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)Master's Degree… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …drug development plan, design, conduct, and interpret Phase 1 (specifically Clinical Pharmacology) studies, support Phase 2/3 studies, represent function on study ... of PK-PD and Pop PK-PD concepts and analysis, phase 1-4 clinical studies, literature, regulatory guidelines, and physiological/pharmacological aspects of the drug.… more
