- Recursion (New York, NY)
- …to support Budget planning and forecasting. The Team You'll Join Reporting to the Senior Director , Clinical Data Management and working closely with ... Strong knowledge of regulations and guidelines that apply to the conduct of clinical trials Excellent written and verbal communication skills and ability to… more
- Merck & Co. (North Wales, PA)
- …Degree in life sciences, preferred.Ideal candidate would have:Experience in conducting global clinical trials , including trial initiation through database ... the scientific planning and execution of one or more clinical trials or significant aspects thereof.- In...clinical protocol(s). This may include:Serving as the lead clinical scientist on the clinical trial… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …non- clinical and clinical factors, diagnosis, effective management during clinical trials and beyond in post approval setting.Responsible for the ... CSPV and other internal groups) and outside of Daiichi Sankyo (eg clinical trial sites, CROs, collaboration partners); Supports effective direct communication… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the ... Collaboration and partnership with other functions and stakeholders in supporting clinical trial monitoring and execution through RBQM activities. Accountable… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... Planning and Execution: Provides input on major milestones of trial , clinical trial plan and...CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials . Recognizing that this development bottleneck may ultimately limit the number ... capabilities to accelerate all aspects of drug development and clinical trials . Formation Bio partners, acquires, or...faster and more efficiently.About the PositionWe are seeking a Senior Director , Biologics to lead all Chemistry,… more
- Merck & Co. (Rahway, NJ)
- … supply chain across the full Company's Research & Development Division portfolio of clinical trial s .- GCS is accountable for the planning, sourcing, labeling, ... effectively communicate with stakeholders at various levels, including cross-functional teams, senior management, external vendors, and clinical sites. Strong… more
- Teva Pharmaceuticals (West Chester, PA)
- …Therapeutic Area Head to lead the strategic and operational global execution of all clinical trials within the Neuroscience TA. This leadership role oversees a ... 15-20 professionals and is accountable for driving excellence in clinical trial delivery, cross-functional collaboration, and operational innovation… more
- Abbott (Santa Clara, CA)
- … of Clinical Programs will lead the portfolio of clinical trials including clinical trial strategy development and execution to support evidence ... timelines. The individual will also lead interactions with key opinion leaders, clinical trial investigators, regulatory agencies, and reimbursement agencies to… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials . Recognizing that this development bottleneck may ultimately limit the number ... processes, and capabilities to accelerate all aspects of drug development and clinical trials . Formation Bio partners, acquires, or in-licenses drugs from… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and leads technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing ... laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some… more
- Merck & Co. (North Wales, PA)
- …outcomes research support for Oncology programs.- The position reports to the Senior Director responsible for Portfolio Real-world Evidence (RWE) in Oncology.- ... evidence required by HTA/payers globally including value dossiers, evidence synthesis, clinical trial value endpoints, and support economic modeling globally… more
- Eisai, Inc (Nutley, NJ)
- …plan. Provide strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for ... for assigned therapeutic area. Under the direction of the Senior Medical Director , this role will be...across areas of Medical Affairs' functions or phase II/III/IV clinical trials and diseases in the therapeutic… more
- Takeda Pharmaceutical Company Limited (Lexington, MA)
- … Science Lead and TA Medical Teams. Drive and deliver all aspects of clinical trial execution from study concept to final reporting Research and Strategic ... application is true to the best of my knowledge. Job Description Associate Director , Clinical Research, Value & Evidence Generation, US Medical Lexington, MA… more
- Merck Group (Billerica, MA)
- …program, including responsibility for clinical development strategy and execution of clinical trials . You will provide medical and clinical guidance ... for the Global Development Neurology therapeutic team, plan, guide and manage clinical trials , aiding study design and interpretation of results. You will… more
- Cytokinetics (South San Francisco, CA)
- …contractility. Job purpose Cytokinetics is seeking an experienced and highly motivated Senior Director , Regulatory Affairs to join the Global Regulatory Affairs ... team. The Senior Director will be responsible for developing,...NDA/BLA/MAA, and other global submission documents in support of clinical trials and marketing applications, and their… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials . Recognizing that this development bottleneck may ultimately limit the number ... processes, and capabilities to accelerate all aspects of drug development and clinical trials . Formation Bio partners, acquires, or in-licenses drugs from… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vs retrospective analyses and collection, missing data, demographic/representativeness of samples from clinical trial and screen failures. Clinical trial ... study/IVDR performance evaluation study integration of an assay into clinical testing (before testing) and once data is ready...and risks in written and verbal format to regulatory senior leadership team and other governing bodies required Travel:… more
- Deciphera Pharmaceuticals (Waltham, MA)
- Company Description Job Description The Senior Clinical Project Manager leads and manages a more complex clinical studies, demonstrating a higher level of ... decisiveness and strong judgement What You'll Do: Ensures successful clinical trial planning, execution and delivery within...approaches to clinical studies May manage several clinical trials through leading and delegating to… more
- Barrington James (Madison, OH)
- …patients worldwide. Position Overview Reporting to senior leadership within the Clinical Development function, the Medical Director will contribute to ... will focus on the medical and scientific oversight of clinical trials from design to regulatory submission....& Strategy Act as a key medical contributor to clinical development plans and clinical trial… more
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