- 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)
- …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
- 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
- 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
- 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. (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 (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
- 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- … System , Inventory Management, Mechanical Testing, Medical Device Quality Systems , Negotiation, Project Management, Quality Management Systems (QMS), ... & Technology (DD&T) organization within the Pharmaceutical Sciences and Global Clinical Supply (GCS) global organization. This role is critical in looking… 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
- 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. (North Wales, PA)
- …and maintain statistical databases that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.Act as a ... Job DescriptionPosition description:- Lead the statistical programming activities for multiple and/or large/complex late-stage drug/vaccine clinical development… more
- Merck & Co. (Rahway, NJ)
- …identifying and implementing novel quantitative approaches (for eg, comparator modeling, clinical trial simulations,- quantitative system pharmacology (QSP) and ... offers an opportunity for the Pharmacometrics leader to drive pipeline impact and lead a talented group of pharmacometricians.This director will be part of a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: This is ... of the Signal Management Center of Excellence (CoE) will lead the daily strategic initiatives to standardize, optimize, and...instruct teams on how to properly conduct high quality clinical evaluation of signals in the appropriate tool (eg,… more
- Merck & Co. (Rahway, NJ)
- …seek out, anticipate, and solve significant scientific and technical challenges. Lead complex investigations into technical challenges related to design, ... coach and mentor others to grow their technical rigor to lead and/or contribute to investigations and resolutions.Cross-Functional Collaboration:Act as the primary… 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, ... and execute the medical affairs plan, including medical education, research grants, medical advisory boards, and scientific communication/publication components of… more
