- Statistics & Data Corporation (SDC) (Waltham, MA)
- …support *Develop, coach and mentor junior biostatistics department personnel *Act as the lead statistician on clinical research projects and help with ... research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …updates Study Supply Plans in close communication with CSO project Management Lead .Responsible for the Clinical Label Development process which includes creation ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....position is responsible for enabling the on-time delivery of clinical supplies across the DSI portfolio. This role is… more
- Merck & Co. (Rahway, NJ)
- …Outcomes Research .Under the guidance of a senior leader, this individual will lead a team of outcomes research professionals to develop value evidence ... Job DescriptionRole Summary:The Executive Director, Value & Implementation (V&I) Outcomes Research position resides in the V&I organization, which includes Global… more
- Merck & Co. (Rahway, NJ)
- …in quality management or business management is preferred.Prerequisites:Minimum of 6 years in clinical research including at least 2 years with developing and ... Job DescriptionIn partnership with the Clinical Quality Operations Lead (CQOL and...managing clinical quality systems and management of regulatory… more
- Eisai, Inc (Nutley, NJ)
- …audit and inspection management, issue management and oversight of the Quality management system . This role is responsible for Good Clinical Practice (GCP) and ... in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of...your profile, we want to hear from you. The Clinical Quality Assurance Professional (QAP) position is responsible for… more
- Insmed Incorporated (San Diego, CA)
- …leader managing quality and regulatory compliance related to GCPs, acts as quality lead on the gene therapy clinical development team, and collaborates on ... day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've...systems approaches consistent with ICH E6 for Good Clinical Practice.Must be able to foster a collaborative environment,… more
- Kenai Therapeutics (San Diego, CA)
- … development strategy, ensuring it meets regulatory, scientific, and commercial needs. Clinical Trial Oversight: Lead the planning, design, and execution of ... ensuring continuous safety monitoring and compliance. Team Leadership & Development: Lead , mentor, and develop a high-performing Clinical Operations team,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionApplications are sought for a Process Engineering Lead position in o ur Reseach & Development Division Biologics Process Research & Development ... The incumbent will support GMP capability build for the production of clinical supplies of bulk biologic drug substance at a state-of-the-art Next Generation… more
- DERMCARE MANAGEMENT LLC (Hollywood, FL)
- …leadership, patient recruitment, trial management, and achieving organizational goals in clinical research . RESPONSIBILITIES: Operational Leadership Lead and ... Operations plays a key leadership role in overseeing the daily operations of clinical research sites within a designated region. This position is responsible… more
- Merck & Co. (Upper Gwynedd, PA)
- …BS degree required, focus in Data Science, Computer Science, Management Information Systems or relevant clinical domain degree preferred. Required Experience and ... Associate Director within Metrics, Analytics & Performance (MAP) has experience in clinical operations and is responsible for leading the development of analysis,… more
- Insmed Incorporated (San Diego, CA)
- … Clinical Development teams, Regulatory Affairs, and external partners.ResponsibilitiesEDC System Design & Development: Lead the setup, development, and ... be responsible for the development and implementation of EDC systems to support clinical trials, ensuring data...with Medidata Rave. Proven track record of leading EDC system design and implementation for clinical trialsAdvanced… more
- Merck & Co. (Boston, MA)
- …Development, Stakeholder Engagement, Stakeholder Relationship Management, Strategic Planning, System Designs, Systems Development Lifecycle (SDLC)Preferred ... Job DescriptionLocation: PA, NJ, Boston/CambridgeJob Description: The Research and Development Sciences (RaDS) value team in...the RaDS Product organization. The position will report to the- Lead of the Disease Biology and PharmTox Product Line.… more
- Merck & Co. (Rahway, NJ)
- …account planning initiatives to enhance collaboration and alignment across Health System accounts.Provides scientific consultation to Our Company's Research ... TA aligned deliverables that align with V&I Goals and serves as the Lead for the US Medical Affairs Team (MAT) meetings.Establish and maintain strategic partnerships… more
- Eisai, Inc (San Francisco, CA)
- …and confidence in discussing drug information/ disease state management. Prior experience in clinical research , drug development and/or clinical pharmacy and ... MSL , 8+ years of overall experience in Oncology with relevant combination industry/ clinical / research / academia; at least 5 years as an MSL in Oncology… more
- Eisai, Inc (Nutley, NJ)
- …is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, ... Eisai portfolio. This role participates in HEOR and RWE research with the goal to contribute to the development...to contribute to the development and the communication of clinical , real-world, health economics outcomes data. This role primarily… more
- Formation Bio (New York, NY)
- …pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines ... promising therapeutics while ensuring these capabilities evolve into robust, production-ready systems .Responsibilities Lead the Platform Science arm of Data… more
- Merck & Co. (San Diego, CA)
- …and key strategic engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)-Ability to manage ... feasibility, and execution of a clinical trial.-This may include:May serve as the clinical trial team lead -May lead team in key study planning,… more
- Eisai, Inc (Atlanta, GA)
- …is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, ... Area Business Leader (ABL) will engage with assigned health systems for Eisai's oncology portfolio and manage a team...KOLs, Pathway and PandT committee members). Each ABL will lead account responsibility for a defined number of potential… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ensure high data quality, proactively identifying and resolving issues throughout the clinical trial process. Customer Focus / Stakeholder:Engagement Lead the ... collaboration with business functions. Provide expert guidance to enable successful inspections. Lead /Support local inspections by providing adequate systems and… more
- Merck & Co. (North Wales, PA)
- Job DescriptionGlobal Project and Alliance Management (GPAM) sits in the Research & Development Division (R&D). The Project Managers in GPAM are core members of ... the guidance of the CIPM Staff Manager & Portfolio Lead , the core responsibility of this senior Project Manager...be cross divisional and relate to optimizing PM capabilities, systems , and operations (e,g., leading efforts to improve planning… more
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