- Merck & Co. (Rahway, NJ)
- … to post-licensure). With a focus on late-stage development, the Senior Director will manage the entire cycle of clinical development, including study ... with key opinion leaders. Specifically, the Senior Director May Be Responsible For: Evaluating pre- clinical ... Research, Clinical Studies, Clinical Trial Protocols, Clinical Trials , Early… 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
- 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
- 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
- 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)
- …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
- 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
- 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
- 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
- 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. (Rahway, NJ)
- …limited to Investigational New Drugs, Investigational Medicinal Product Dossier s, and Clinical Trial Application s.Ability to work closely with cross-functional ... pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research… 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Senior Engineer in Device Design and Process Development group, you will be part of our Research & Development team that designs and develops ... benchtop/low-volume to high-volume clinical and commercial assembly equipment and processes for medical...processes for medical devices/drug delivery systems. Reporting to the Director responsible for this area, you will partake in… more
- Eisai, Inc (Phoenix, AZ)
- …customer business, disease state, product prescribing information, approved promotional clinical trials , patient access to medication, and regulatory/compliance ... If this is your profile, we want to hear from you. The Senior Oncology Sales Specialist is responsible for meeting/exceeding sales goals through promoting Oncology… more
- Teleflex (Wayne, PA)
- Senior Director , Clinical Evidence Generation...At least ten years of related work experience in clinical trials or outcomes research obtained in an ... in patients' lives. **Position Summary** The position of Sr. Director , Clinical Evidence Generation is a newly...experience in clinical research. * Experience with Clinical Trial Systems, in particular EDC, CTMS,… more
- J&J Family of Companies (Titusville, NJ)
- …at https://www.jnj.com/innovative-medicine **POSITION SUMMARY:** The incumbent will serve as a Senior Director , Clinical Leader in Neurodegeneration, ... + Strategic mindset + Experience and interest in innovative clinical trial design + Fluent in written... Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- … Director provides clinical oversight to one or more clinical trials . Additionally, the Senior Director guides the project teams to design and ... seeking a highly motivated individual to join us as Senior Medical Director , Clinical Development...with experience designing, implementing and conducting clinical trials , with emphasis on late study trial … more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Senior Medical Director , Clinical Development, will play a key role in clinical development programs within the Internal Medicine portfolio focused ... demonstrates outstanding clinical scientific knowledge applicable to clinical research. The Senior Medical Director...early or late development + Past experience in leading clinical trials including: protocol design, managing study… more
