- Catalent (New York, NY)
- …health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion ... Account Director , Biologics Drug Substance Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative… more
- Novo Nordisk Inc. (New York, NY)
- …educational workshops, round tables, medical forums, etc. May explore and identify sites for clinical trials in all stages of development. Incumbents have a deep ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...(territory and account) plans in coordination with his/er Field Director . Relationships Position reports to Field Director /Senior… more
- Catalent (New York, NY)
- …health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion ... Global Nutritional & Beauty Business Development Team reporting to the Regional Director Beauty Softgels North America, and responsible for managing new business… 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)
- …serving as the primary point of contact.- Review and analyze data from clinical trials , post-marketing and other relevant sources for the prompt identification ... of safety signals. Review and evaluate serious adverse event reports from clinical trials or post-marketing for completeness, accuracy, expectedness and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …operational planning and execution of FIH, clin pharm patient studies, and Phases 1-3 clinical trials at the study and program level. Responsible for clinical ... of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , 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, ... identify Data Standards gaps and resolve issues related to clinical data standards development throughout the trial ...data activities required7 or more years experience in Oncology trials with an understanding of the complex and interdependent… more
- 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
- Insmed Incorporated (Bridgewater, NJ)
- …and Key Performance Indicators (KPIs). This role works closely with the Clinical Program Operations Leads, Clinical Trial Managers/Leads (US ... of materials, and distribution to executive leadership.Manages vendor(s) for clinical trial data visualization dashboards to ensure...should have a minimum of 8 years' experience in clinical trials with a sponsor or CRO… 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, ... 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
- Tris Pharma (Monmouth Junction, NJ)
- …and other existing/investigational products, liaising with key opinion leaders (KOLs), clinical trial investigators and internal scientific, pharmacology and ... facility for an experienced MD to serve as Senior Director or Director , Clinical Development....by working closely with local functions on the full clinical trial life cycle; Reviews, synthesizes and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Voice Strategy and Infrastructure.Build processes withing GCO to achieve diversity in clinical trials and patient focused drug development (ie. Patient voice) ... vendors, or investigative sites on the importance of representative diversity in clinical trials and patient voice.Identify innovative approaches, industry best… 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
- 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 ... trials of medium to high complexity in design and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory… 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
- Insmed Incorporated (Bridgewater, NJ)
- … development experience in the pharmaceutical/biotech Industry. Previous experience conducting clinical trials in Dermatology is a plusWorking knowledge of ... development experience in the pharmaceutical/biotech Industry. Previous experience conducting clinical trials in Dermatology is a plusWorking knowledge of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …execution requiredStrong experience in procedural writing and life cycle management requiredAdditional clinical trial process experience in one or more key ... research areas centered around rare diseases and immune disorders.Summary The Associate Director , Global Clinical Operations (GCO) Procedural Ownership and Life… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and provide comments to trial outlines/protocols for Novo Nordisk-sponsored clinical trials Review proposals for investigator-sponsored studies (ISS) and ... National Leaders/National Expert Panels for select clinical trials , in collaboration with Clinical Director... Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director ,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …investigators is expectedThe CS Group Lead will also ensure the writing of high-quality clinical trial protocols, review of clinical data and Clinical ... Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical ...Senior Director level for each respective programThis Clinical Science (CS) Group Lead will be responsible for… more
- Merck & Co. (Rahway, NJ)
- …translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial simulation, disease progression models, quantitative ... and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications… more
