- 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)
- … to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication;Participation in internal and joint ... Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new… more
- Merck & Co. (South San Francisco, CA)
- …I studies ; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, drug ... for planning and management of an important inflection point in the drug development process, working closely with scientific, regulatory, statistical, and modelling… 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. (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. (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)
- …Evidence (RWE) in Oncology.- -Position objectivesTo design and execute real-world evidence studies , designed to demonstrate the value of new products in support of ... inform and contribute to the value evidence plan and associated studies which demonstrate clinical, economic, and patient-centered value. The work will… more
- Aequor (East Syracuse, NY)
- …in Biology, Chemistry, Biotechnology, or equivalent area of related study with 0-5 years industry experience in biologic/protein analytics.Experience across ... used in the testing and characterization of raw materials, excipients, in-process, drug substance, and drug product samples including HPLC/UPLC methods and… 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)
- …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)
- …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)
- …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
- Merck & Co. (Rahway, NJ)
- …for small, intermediate, and large molecules from preclinical toxicology studies to commercialization. -Our development teams ensure robust composition, primary ... In summary, our team enables the translation of preclinical candidates into non-oral drug products.We are seeking a highly motivated candidate for the position of… 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
- 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
