- Merck & Co. (Rahway, NJ)
- …s as the lead GCS spokesperson at clinical and development related meetings.- Working independently, the Program CSPM designs strategic and operational ... partner organizations ( as a lead GCS Planning program representative ) such as clinical development , regulatory, quality and other supply chain areas… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and updates Study Supply Plans in close communication with CSO project Management Lead .Responsible for the Clinical Label Development process which includes ... 7 or More Years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development . preferredOncology experience… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and ... lead the development and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of the other sections in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …& Leadership:Has primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan ... and quality metrics and share with study team, Operations Program Lead , and Sr. Director for the...Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO, 3rd… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharm patient studies, and Phases 1-3 clinical trials at the study and program level. Responsible for clinical program planning and execution (from study ... and leads the successful execution of all operational components of a large-scale global clinical program using strong clinical project and program … more
- Merck & Co. (Rahway, NJ)
- …ensure full integration of the device development activities with the clinical , regulatory, formulation, commercial and other key Ofunctions. Lead the Device ... with applicable regulatory, quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device… more
- Formation Bio (New York, NY)
- …and collaborate with colleagues throughout the company, including our Medical/R&D, Biometrics, Clinical Program Management, and Clinical Operations teams to ... progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck...patients faster and more efficiently. About the PositionAs a Lead Product Manager, you will help execute on our… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Merck & Co. (Rahway, NJ)
- …laboratory / regulatory documentation. Active strategic and technical leadership on program development teams, interfacing with key stakeholders, and ... development expertise with exposure to all stages and aspects of development (preclinical, clinical , and commercial) and cGMP industrial background.Capable of… more
- Merck & Co. (Rahway, NJ)
- …diagnostics strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development . The successful candidate will have an essential ... strategies and interact with various stakeholders to ensure alignment with clinical development timelines and regulatory requirements. Most importantly, the… more
- Merck & Co. (Rahway, NJ)
- …all submissions and associated documentation.Provides expertise as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact ... for meetings with FDA at any phase of drug development . Lead cross-functional efforts to prepare for... experienceM.D. with minimum of 3 years relevant drug development experience or clinical experiencePhD/PharmD with minimum… more
- Merck & Co. (Rahway, NJ)
- …Area and strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development .- The AVP provides strategic oversight for the early ... direction of clinical programs involving translational research and early clinical development for the Cardiovascular & Respiratory Therapeutic Area.- They… 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 ... technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or… 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
- Merck & Co. (Rahway, NJ)
- …The Associate Director will perform job duties independently with minimal supervision and/or lead QP2 efforts on drug/vaccine development programs, and author or ... and Pharmacometrics (QP2) department drives model-informed drug discovery and development (MIDD) to routinely enable efficient drug discovery/ development … 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
- Merck & Co. (Rahway, NJ)
- …and Pharmacometrics (QP2) department drive model-informed drug discovery and development (MIDD) to routinely enable efficient drug discovery/ development ... offers an opportunity for the Pharmacometrics leader to drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Sub-team and to drive the development and delivery of the clinical development plan in alignment with the product development strategy.Manages ... with the Global Team leader as the Project Management lead on drug development projects. This position... and ensures the execution of the integrated product development plan.Partners with the Clinical Team Leader… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …cross-functional Medical Safety collaborations within and across line functions, eg Clinical Development , Medical Affairs, Regulatory Affairs, Clinical ... external stakeholders on important drug safety issues supporting Global Medical Safety Lead . Responsible for safety governance/oversight of Clinical Safety and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Biologics Analytical Research & Development department of our company's Research Laboratories Division is seeking applicants for a Principal ... with working closely with the group Director to define group strategy and to lead a team of scientists in solving complex analytical problems at the interface of… more
