- 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)
- …pharm patient studies, and Phases 1-3 clinical trials at the study and program level.Responsible for clinical program planning and execution (from study ... leads the successful execution of all operational components of a large-scale global clinical program using strong clinical project and programmanagement,… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …a manufacturing readiness strategy to deliver capacity ramp up to meet clinical and commercial demand.Drive capacity evaluations and lead action implementation ... information requests associated with executed capacity studies, as needed.Coordinates the development of operational models to meet clinical and commercial… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …GDIM to drive technology-enabled process improvements. Build strong relationships with clinical development , clinical sciences, regulatory, biostats, data ... strong collaboration. Partner with other functional excellence colleagues, such as clinical development , to ensure harmonization. Responsible for maintaining… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …record in executing effective project management in cross-functional drug development teams or clinical , regulatory, pharmaceutical sciences/technical operations ... for providing operational excellence project management support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will partner… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …communication of emerging data (internal or competitive), such as congress updates and development program highlights; and budget and forecast accuracy- In a ... the direction of the Senior Director, USMA Oncology (US 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
- 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 ... of the Senior Director/Director, GMA Oncology (Global Medical Affairs team lead for compound), is responsible for assisting with defining compound/ program… 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)
- …Skills: Academic Quality Improvement Program (AQIP), Academic Quality Improvement Program (AQIP), Adaptability, Budget Development , Clinical Supply Chain ... with clear roles & responsibilities, governance forums, KPIs, and service delivery expectations. Lead development and adoption of data policies, standards, and… 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 director will be part of a… more
- Formation Bio (New York, NY)
- …and product teams. These predictive models will seamlessly integrate with our Clinical Development processes, directly impacting trial design and execution. This ... progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck...Data Science - Platform at Formation Bio, you will lead one of two critical arms of our Data… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Commercial, Market Access and Public Affairs, Legal, Finance and Investor Relations, Clinical , Medical and Regulatory, plus other cross functional teams as needed. ... stakeholder perceptions in line with the Corporate Reputation strategy Directs development of media strategies and key message platforms, prepares/coaches senior… more
- Merck & Co. (Rahway, NJ)
- …Material(s):n/aRequired Skills:Analytical Method Development , Assay Development , Bioanalytical Analysis, Business, Chromatographic Techniques, Clinical ... Job DescriptionThe Biologics Analytical Research & Development department of our company Research Laboratories Division...the group Director to define group strategy and to lead a team of scientists in solving complex analytical… more
- Terumo Medical Corporation (Somerset, NJ)
- …**_Advancing healthcare with heart_** **Job Details/Responsibilities** 1. Strategic Planning and Execution: Lead the development and implementation of short- and ... practices and Design Control when participating in new product development and clinical activities. Fully adhere to...success of this position is the ability to successfully lead a commercialization strategy which ensures the company's ability… more
- Optum (New York, NY)
- …of our vision to make healthcare better for everyone. At Optum, you'll have the clinical resources, data and support of a global organization behind you so you can ... and out of the hospital, or those with life-limiting illnesses. The physician will lead the team in high-risk patient care and the transition of care management.… more
- Terumo Medical Corporation (Somerset, NJ)
- …products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part ... as per the Business Requirements. + Contribute with the development of the SAP Security Strategy that is well-designed,...authorizations, roles, and data access control. + Ability to lead critical issues involving SAP on GCP, Fiori with… more
- Terumo Medical Corporation (Somerset, NJ)
- …products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part ... Privacy Officer is responsible for managing the privacy, data management, and security program at Terumo Americas Holding, Inc. and certain of its subsidiaries and… more
