- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery… more
- Merck & Co. (Rahway, NJ)
- …teams and the operational/executional arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing...(GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full our Research &… more
- Merck & Co. (Rahway, NJ)
- …operational/executional arms within the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing...(GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full of our company's… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary: The Manager , Clinical Data Repository Administration is a member of the ... maintenance of standard hierarchy structures and user access controls for all clinical studies. This position may have direct reports and/or dedicated external… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …project manager for other activities involving assigned product(s) or clinical studies, as needed.QualificationsSuccessful candidates will be able to meet the ... position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …project manager for other activities involving assigned product(s) or clinical studies, as needed.QualificationsSuccessful candidates will be able to meet the ... position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …project manager for other activities involving assigned product(s) or clinical studies, as neededQualificationsSuccessful candidates will be able to meet the ... This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Job Summary: Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical ... Monitor. Represents Clinical Development on Study Team and collaborates as team...with other functions, ARO, CRO. Provides scientific input to Clinical Operations and other functions. This position provides critical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Summary: This position is responsible for enabling the on-time delivery of clinical supplies across the DSI portfolio. This role is primarily responsible for ... streams with key service providers and working with internal departments to progress clinical supply projects. Every effort has been made to identify the essential… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Job Summary: This position resides within the Functional Excellence and Clinical Biomarker Oncology department of the Global Precision Medicine function. The ... Manager , CDx Diagnostics Scientist's primary responsibilities are:Assists in defining...in defining the biomarker assessment and implementation plan for clinical trials.Executes biomarker testing and data capture at central… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Proactively seeks to become an expert in complex outsourcing models supporting Clinical RD and PH.1 to PH. IV outsourced services (eg, CRO, Biomarker, ... CDx, Clinical Supplies, central labs); Must have strong problem-solving skills...the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing, ... with a deep understanding of the drug discovery and development process, clinical trials, and regulatory requirements. TravelAbility to travel up to 5% Occasional… 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 of ... capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs...and more efficiently. About the PositionAs a Lead Product Manager , you will help execute on our tech strategy… 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 of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a QA Laboratory Compliance Manager as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Laboratory Compliance Manager ... program for the site Quality Control laboratories in support of both clinical and commercial manufacturing. This role will be responsible for managing Laboratory… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Program Manager , Cleaning Validation as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Program Manager , ... CAR-T Environmental Monitoring Immediate Action team in support of on-going clinical and commercial manufacturing as well as facility expansions and improvements.Key… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking Senior Project Manager , PMO as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be responsible ... 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)
- …and ensures the execution of the integrated product development plan.Partners with the Clinical Team Leader to ensure a high performing Clinical Sub-team and ... to drive the development and delivery of the clinical development plan in alignment with the product development strategy.Manages the team meetings including… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies ... team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.- Drug Development Strategy: Provides input to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …oversight over the site Quality Control laboratories responsible for testing of pre- clinical , clinical , and commercial stage CAR-T cellular therapy products. ... providing quality oversight for site Quality Control laboratories responsible for testing pre- clinical and clinical and commercial stage CAR-T cellular therapy… more
