- 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 to and… more
- Merck (Upper Gwynedd, PA)
- …the 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
- 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)
- …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
- 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
- J&J Family of Companies (Horsham, PA)
- …Team. The TAH, Lung will be an expert in medical strategy development and will lead a group of Medical Directors (MDs) to develop overall strategy for the ... belong. The Therapeutic Area Head (TAH), Lung, Medical Affairs Oncology will lead a multifaceted critical function for the operating company by supporting multiple… 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
- Merck (West Point, PA)
- …Key deliverables include stage appropriate portfolio decisions, advancing lead identification, translational strategy, clinical candidate selection, ... team in West Point, PA. The leader of this group will have broad responsibilities in three interconnected areas...of In Silico tools and modeling techniques to accelerate lead optimization/selection and the progression of clinical … 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)
- …cross-functional team in the disease area. + Writes or coordinates all types of clinical and regulatory documents, taking a proactive lead role in driving ... in MW and cross-functional meetings as appropriate (eg, submission team meetings, study team meetings, clinical team meetings). + Maintains and disseminates… more
- Merck (West Point, PA)
- …Our department is responsible for developing vaccine adjuvants and drug products from preclinical studies through Phase III clinical trials with line of sight to ... to develop stable formulations and robust manufacturing processes for preclinical and clinical supply production and to scale-up these processes to the pilot plant… more
- J&J Family of Companies (Horsham, PA)
- …Rheumatology market understanding, evolution of that market with competitive entrants & internal clinical studies , and an insights development plan + Shape Field ... one of J&J's lead assets, TREMFYA(R). This position reports to the Group Product Director, HCP Marketing. Key Responsibilities: + Own the HCP brand strategy,… more
- J&J Family of Companies (Spring House, PA)
- …& Asset Management organization as part of the wider CDTL community. They will lead a cross-functional compound development team to maximize the value of the asset ... team to deliver against the asset strategy. Beginning at Lead Optimization entry the CDTL drives the development and...product profile in collaboration with commercial, market access and clinical groups, and adjust this profile as new information… more