- Pfizer (Collegeville, PA)
- …the way in healthcare and make a lasting impact on society. **What You Will Achieve** As a Clinical Study Group Lead , you will be an operational and ... 5 submission subteams and endgame inspection readiness. In the Clinical Study Group Lead... studies + Accountable to deliver excellence in clinical study team leadership for a portfolio… more
- Merck (North Wales, PA)
- …Director, PDT lead will manage the entire cycle of clinical development, including development strategy, study design, initiation, execution, monitoring, ... safety and efficacy as well as new drug applications, clinical study reports, or publications. + Participation...entire Clinical Teams in the execution of clinical studies . + Will report and work… more
- J&J Family of Companies (Spring House, PA)
- …searches and review, medical review of trial data, coordinating the completion of clinical study reports and provid ing support (as needed) for preparation ... of complex compound programs in Phase I to III clinical oncology or immunology studies . The ...team meetings + Participat ing in cross-functional team and clinical team meetings + Develop ing study … more
- Pfizer (Collegeville, PA)
- …Intake processes to optimize efficiency and compliance with regulatory requirements. + Lead and manageaudits within the Study Organization (SO), including ... (R&D) engine providing analytics & intelligence to customers and stakeholders across clinical and regulatory functions within PRD & POD. The Site Intelligence,… more
- Merck (Upper Gwynedd, PA)
- …activities of Clinical Scientists in the execution of clinical studies . Work closely with a cross-functional group of experts in commercialization, ... trials for investigational drugs + Analyzing and summarizing the clinical findings from studies to support decisions...safety and efficacy as well as new drug applications, clinical study reports, or publication; and +… more
- Merck (Upper Gwynedd, PA)
- …including those new to the organization therefore requiring someone who has built and lead clinical development plans from the ground up. They will also be ... responsible for guiding Product Development Team Leaders and Clinical Directors within their group to ensure...pipeline candidates and licensed products + Supervises development of clinical documents including protocols, clinical study… more
- University of Pennsylvania (Philadelphia, PA)
- …tissue samples, participate in initiation, monitoring, audit and close-out visits, coordinate study team meetings, disease site and/or discipline group meetings, ... Specialist, Billing Compliance staff, and Finance office to develop clinical trial budgets. Communicating any specialized study ...and report to their team the status of all studies within their group , including accrual, data… more
- J&J Family of Companies (Spring House, PA)
- …deployment of DAS or program level feasibility strategies and incorporate them into study -level strategies and plans. + Lead process of aligning trial baseline ... of the processes associated with study / site feasibility, study /project management, monitoring, clinical and regulatory operations. + Broad-based experience… more
- J&J Family of Companies (Spring House, PA)
- …Medicine (TM) and Translational Science (TS). TM has combined expertise in the clinical study of immunologic disease, immunologic pathways, and in early ... pivotal bridge between Discovery Research and the later phase Clinical Development group . TSM provides the necessary...Direct and supervise the preparation and review of protocols, clinical study reports, clinical pharmacology… more
- Merck (West Point, PA)
- …of Phase I studies ; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, ... perspective into the earliest stages of target identification and validation, and executing clinical studies to evaluate the relevance of potential targets to… more
- J&J Family of Companies (Titusville, NJ)
- … studies including conceptualizing the research questions, data feasibility, study design, analysis, and interpretation. + Provide thought leadership and hand-on ... area RWE expertise and whose responsibilities include: + Independently lead , manage, and mentor a large multidisciplinary team of...external control arm studies , hybrid control arm studies , retrospective and prospective study designs and… more
- J&J Family of Companies (Titusville, NJ)
- … studies including conceptualizing the research questions, data feasibility, study design, analysis, programming, and interpretation. + Provide thought leadership ... external control arm studies , hybrid control arm studies , retrospective and prospective study designs. +...to perform frequently used actions and/or deliverables across broad group of stakeholders. + Partner with the Data Science… more
- Charles River Laboratories (Wayne, PA)
- …from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone ... Planning and ensuring on-time delivery of client projects. + Lead the development, qualification and validation of new assays...Virology assays and tests, the manager assures that: + Study or assay protocols are approved as provided by… more
- System One (Horsham, PA)
- …Council of Biology Editors, as well as ICH and other regulatory guidelines pertaining to study protocols and clinical study reports. Education: + A minimum ... peer-reviewed publications and congress submissions of data from our company-sponsored clinical and observational studies . Key Responsibilities: + Collaborate… more
- ICON Clinical Research (Blue Bell, PA)
- …+ Expert knowledge of applicable ICON/Accellacare systems + Reporting on team and study deliverables + Lead the development of training materials to support ... Client Engagement ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving… more
- IQVIA (King Of Prussia, PA)
- …analysis, interpretation, and dissemination of findings. In particular, the QualityMetric group within IQVIA focuses on clinical outcome assessment (COA) ... quantitative research services team supports a broad range of studies aimed to better understand the patient's experience related...role should be a scientist first, who can also lead and develop talent and will be responsible for… more
- J&J Family of Companies (Titusville, NJ)
- This role will direct and lead efforts to bring innovative approaches to the use of Real World Evidence (RWE) to the Oncology Clinical Development Teams. You ... requires both a broad knowledge of drug development, including clinical trials and application of RWE in drug development....internal and external partners to execute high impact RWE studies . This includes identifying and procuring data sets for… more
- J&J Family of Companies (Spring House, PA)
- …all types of clinical and regulatory documents, taking a proactive or lead role in terms of content and scientific strategy. + Establishes and drives document ... will manage a pool of internal writers and will lead early development writing projects. The successful candidate: +...cross-functional meetings as appropriate (eg, global program team meetings, study team meetings, clinical team meetings). +… more
- J&J Family of Companies (Malvern, PA)
- …within the API-Large Molecule group in Malvern, PA. The candidate will lead the design and execution of development studies and use engineering principles ... perform purification process development for antibody-based modalities within the API-Large Molecule group . + Design and execute development studies to enhance… more
- J&J Family of Companies (Spring House, PA)
- …people can reach their potential. At Johnson & Johnson, we all belong. The Lead Discovery & Mechanistic Pharmacology team is a critical part of the Therapeutics ... chemical leads needed for the generation of small molecule clinical compounds in all five J&J Therapeutic Area (TA)...our team as an Experienced Scientist in the Enzymology group . This position will report to a senior member… more