- 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
- 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
- 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
- Genmab (Plainsboro, NJ)
- …be our best, and authentic is essential to fulfilling our purpose.Overview The Global Clinical Trial Manager , Team Manager (GCTM-TM) is responsible for line ... support across trials as needed and may assume Global Clinical Trial Manager (GCTM) responsibilities to address fluctuating demands throughout the trial… more
- Genmab (Plainsboro, NJ)
- …essential to fulfilling our purpose.The Role & DepartmentGenmab is seeking an experienced Senior Clinical Drug Supply Manager to join our Global Clinical ... Supply Operations team.As Senior Clinical Drug Supply Manager you will play a pivotal role in ensuring...pivotal role in ensuring the timely delivery of high-quality clinical trial supplies for both early and late-stage trials.… more
- Genmab (Plainsboro, NJ)
- …to be our best, and authentic is essential to fulfilling our purpose.Genmab is seeking a Clinical Drug Supply Manager to join our Global Clinical Drug Supply ... office locations to work according to our hybrid work arrangement.Responsibilities/tasks:Act as Clinical Drug Supply Manager , of the following tasks:Global … 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)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in ... and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other… 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)
- …commercial and IMP as a result of distribution practices, manufacturing sites, clinical sites and testing laboratories and assures they are documented and resolved ... to ensure the quality standards required for DS products are met. Collaborates with internal and external stakeholders to complete deviations in a timely manner.Development and Review of Standards and Procedures (SOPs) and Training Activities: Responsible for… 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
- 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
- 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 ... quality, and output. The Strategy Director serves as the clinical development strategy lead for pipeline projects. This role...to PDPs from NNI PDP Forum Partner with Project Manager to track workstreams under the Project Teams Provide… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D ... the strategic objectives of the organization by bridging the gaps between clinical science and commercialization of our portfolio. The position is dedicated to… more
