- Merck & Co. (Rahway, NJ)
- …Interacts closely with key partner organizations (as a lead GCS Planning program representative) such as clinical development , regulatory, quality and ... to GCS and serves as the lead GCS spokesperson at clinical and development related meetings.- Working independently, the Program CSPM designs strategic… more
- Merck & Co. (Rahway, NJ)
- … Director at this level will be expected to lead a Product Development Team (PDT) through late-phase clinical development and into post-licensure ... journals. The Clinical Director will also contribute to establishing Vaccine Clinical Development Strategies and executing short- and long term research… more
- Merck & Co. (Rahway, NJ)
- …depth and breadth of scientific, technical, and operational experience to lead and support facility operations, process development activities, compliance ... Good Manufacturing Practices (GMP) facility within the Process Research and Development (PR&D) organization which enables gain of critical internal experience during… more
- Merck & Co. (Rahway, NJ)
- …is expected to be experienced in mammalian cell culture or purification process development , tech transfer of clinical or/and commercial processes, and pertinent ... talent development skills. Extensive experience as a drug substance lead for biologics pipeline programs. Strong capability in managing evolving timelines, … more
- Merck & Co. (Rahway, NJ)
- …the project as needed.-This includes the following activities:1. Is involved in late clinical development planning (LDP) to ensure that study designs are ... clinical trials and coordinating the statistical activities for clinical trial projects; and may lead a...software for planned analyses and ascertains needs for potential program development of novel statistical methodology.7. Analyzes… more
- Merck & Co. (Rahway, NJ)
- …execute, design verification strategies for assigned drug-device combination product program (s) for successful clinical introduction(s) and commercial market(s) ... plan, protocol(s), and report(s) that demonstrate design output(s) meet design input(s). Lead establishment of test methodologies, including method development … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trained, following process and SOPs. The Director will ensure the Senior Director, Clinical Operations (Asset Lead ) is fully informed of the overall portfolio ... at the program level through the operational resources assigned to their program . May on occasion represent Global Clinical Operations on the Strategy and… more
- Merck & Co. (Rahway, NJ)
- …Experience and Skills: Strong background in integrated analytical control strategy development and execution. Demonstrated ability to lead a technical ... collaborate to discover the next medical breakthrough.The Biologics Analytical Research & Development department of our Company's Research & Development Division… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to make a difference? The Position The position serves as the lead of Clinical Data Science & Evidence (CDSE) operations. In their role, they ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners,... and operational management of Formation Bio's quality assurance program to support the growing drug development … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …cross functionally with multiple functions and groups throughout the US organization, Clinical Development , Research & Early Development , other affiliates, ... Prioritizes phasing of objectives based on engagement objectives and sales forecasts. Lead the development and execution of annual and long-term brand… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... to providing medical education and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps us all marching to the… more
- Eisai, Inc (Nutley, NJ)
- … Pharmacology will be relied upon to act independently, within a highly-matrixed clinical development organization and must have the experience and conviction to ... and programs according to established design principals and integrates them into the Clinical Development Plan (CDP) and Drug Development Plan (DDP)Leads… more
- Eisai, Inc (Nutley, NJ)
- …members.Requirements Bachelor's or Master's degree with 15 or more years significant clinical pharmaceutical experience (ie, clinical development or ... and assess long-term resource, technology, and skill needs for respective program (s) within clinical quality area.Anticipate immediate and long-term risks… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …function by collaborating with internal and external stakeholders to oversee the development and delivery of clinical data programming, reporting, data ... validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(QRBs).Collaborate with business process owners to monitor the effectiveness of clinical development processes through KQIs, demonstrating process control and ... expertise in the involvement of regulated activities for medical affairs, or clinical development . requiredMust possess a solid understanding of global health… more
- Terumo Medical Corporation (Somerset, NJ)
- …and patient safety throughout the study lifecycle. **Job Details/Responsibilities** Leading the development and execution of Clinical Risk Management Plans and ... Sr. Clinical Quality Specialist Date: Oct 21, 2025 Req...quality issues during study execution Collaborating with stakeholders to lead revisions of processes and documents within the change… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of emerging data (internal or competitive), such as congress updates and development program highlights.- Provides medical leadership in interactions with key ... direction of the Senior Director, GMA Oncology ADC (Global Medical Affairs team lead for compound), is responsible for assisting with defining compound/ program … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pathology, to support design and implementation of translational pathology plans.- Lead development of the translational pathology strategic direction and ... statistical issues related to proposed business plans.- Communicate with portfolio leaders in Clinical Development , Discovery, QCP, CDx, RA, MA or other relevant… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …track training completion rates to ensure compliance with safety and regulatory requirements Lead the development and delivery of training on case processing, ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps… more
