- Merck & Co. (North Wales, PA)
- …Clinical Trial Team lead. Leads and directs teams in key study planning, development, and execution elements (eg operational reviews, issue escalation/mitigations, ... Responsible for facilitating and collaborating with key internal/external stakeholders ( study team, subsidiary country teams, vendors, committees, etc.) in support… more
- Merck & Co. (North Wales, PA)
- …serve as the clinical trial team leadMay lead team in key study planning, development, and execution elements (eg, data management deliverables, trial level ... investigator-meeting planning, communication plans, preparation of status update reports, study close out activities).Leads team for timeline management, risk… more
- Merck & Co. (Rahway, NJ)
- …will manage the entire cycle of late-stage clinical development and studies , including development strategy, study design, initiation, execution, monitoring, ... to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publicationParticipation in internal and joint… more
- Merck & Co. (Rahway, NJ)
- … to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in internal and ... will manage the entire cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically,… more
- Merck & Co. (Boston, MA)
- …a contact for all TK-related issues pertinent to the development of assigned drug candidates and closely interact with toxicology study directors, project ... to the following: conduct TK modeling to support dose-selection on toxicity studies , provide TK study design, calculate PK/TK parameters, interpret results,… more
- Merck & Co. (North Wales, PA)
- …with the Investigator Study Program Committee to evaluate outcomes research study protocols for studies in local markets.Supports affiliates to understand ... and gain input on research design and implementation of retrospective database studies , assessment of patient reported outcomes, epidemiological studies and… more
- Merck & Co. (North Wales, PA)
- …include:Collaborating cross-functionally in the development of Protocol and related study materials (eg, ICF documents / amendments); Partners with the ... Study Manager on study deliverables.Ensuring CRF design...and presentation skillsEducation/ExperienceBachelor's Degree +5 years of pharmaceutical, clinical drug development, project management, and/or medical field experience OR… more
- Merck & Co. (Rahway, NJ)
- …in the SAP system to establish a consolidated , visible forecast for all study product needs (Bulk Drug Product and Clinical Finished Goods).- - Responsible ... for establishing the timelines for clinical supply needs per study and providing the signal for sourcing, manufacturing, packaging,...d evelopment and User Acceptance Testing (UAT) for assigned studies . - Mentors new team members and supports… more
- Merck & Co. (North Wales, PA)
- …as needed. More specifically,-Develops, coordinates, and provides biostatistical support for drug projects under the supervision of management.-Lead a team of staff ... Is involved in late clinical development planning (LDP) to ensure that study designs are consistent with program objectives and meet worldwide regulatory and… more
- Eisai, Inc (Nutley, NJ)
- …or EMEA regulatory agencies handling responses to inquiries and requests for study related information.Strong knowledge base of the drug development process.Deep ... as well as the clinical execution and oversight of the associated studies being conducted globally. The Executive Director will champion transformational business… more
- Merck & Co. (Rahway, NJ)
- …responsibilities include: Collaborating cross-functionally in the development of Protocol and related study materials (e . g . , ICF documents/ amendments); Partners ... with the Study Manager on study deliverables. Ensuring CRF...Education/Experience Bachelor's Degree +5 years of pharmaceutical , clinical drug development, project management , and/or medical field experience… more
- Merck & Co. (Rahway, NJ)
- …:Develops, coordinates, and provides biostatistical support for related drug /vaccine projects under supervision in Late Development Statistics. --Interacts ... clinical trials, and in coordinating the statistical activities for clinical drug /vaccine projects.The incumbent may initially work in a specific disease therapeutic… more
- BioAgilytix (San Diego, CA)
- …fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You'll gain experience with a variety ... scientific and operational activities in support of preclinical, clinical, and product release studies for our San Diego lab. This role requires deep expertise in… more
- Merck & Co. (South San Francisco, CA)
- …biological constructs, and others. The Associate Director is a skilled quantitative drug developer, with a strong, integrated understanding of the strategic elements ... of drug discovery and development. The Associate Director should demonstrate...with external vendors and partners, on activities related to study design, protocol development, study execution, reporting… more
- Eisai, Inc (Nutley, NJ)
- …Maintain and demonstrate thorough and up-to-date knowledge of disease state, study methodology, clinical information, and product data.Demonstrate full knowledge of ... Research Support Facilitate review and follow up of submitted Investigator-Initiated Studies (IISs) and assist with Eisai sponsored trials.Serve as primary contact… more
- BioAgilytix (Durham, NC)
- …fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You'll gain experience with a variety ... Manager (BPM)/Principal Investigator (PI), overseeing all aspects of bioanalytical studies -including project scope definition, proposal preparation, timelines, scheduling, budget,… more
- Merck & Co. (North Wales, PA)
- ….Supervises development of clinical documents including protocols, clinical study reports and background documents.Interfaces with functional experts across ... organization; widely recognized within the organization as an expert in drug development.Demonstrated ability to understand and manage, with appropriate support, the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …programming innovation outside of DS and establish the company reputations and images.- Develop study specific shiny apps or execute shiny apps at study level. ... reporting of clinical trials. required- Having knowledge of all phases of drug development, including early and late phase clinical development and submission… more
- Merck & Co. (North Wales, PA)
- …and seamless cross-functional collaboration to deliver novel strategic program and study design, analysis strategy, and analysis results with highest quality. This ... field, priorities and portfolio needsMaintains continuity of technical knowledge, study design, and analysis strategies across various project teams, fostering… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …units, regions, and functional areas to ensure successful outcomes for projects/ studies . This position has sufficient understanding of regulations and GCP ... requirements for drug development, advanced knowledge of Electronic Data Capture/related applications...This position has advanced experience working on Phase I-IV studies within the pharmaceutical industry across multiple therapeutic areas… more
