- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to make a difference? The Position We are looking to hire an Associate Director of Clinical Operations . This is a unique opportunity to work in ... of trial teams. Relationships This position reports to the Director , Clinical Operations . Essential Functions Collaborate with internal stakeholders… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with the Head of Clinical Development Operations or Senior Director , Clinical Operations on plans for successful implementation of studies. ... for management of compounds at the program and franchise levels. May represents Clinical Operations on the Strategy and Portfolio or Clinical Sub Teams in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Expert Panels for select clinical trials, in collaboration with Clinical Director and Clinical Operations lead Support investigator meetings Serve on ... Clinical Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director , and Field Medical Affairs point to identify… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …finalization through closeout. Relationships Reports to: Associate Director or Director of Clinical Operations . Essential Functions Oversee performance ... is a unique opportunity to work in a growing Clinical Operations Department that manages multiple early-late...identifying areas of concern and escalating to the Associate Director when appropriate Collaborate with the study team to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …OED; considers relevant input and guidance to other areas within NACD including Operations Director and TA Heads Analyze And Anticipate Business Needs: Utilizes ... Collaboration: Responsible for implementation of best practices and standards for clinical operations , including sharing lessons learned. Partner closely with… 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)
- …to drive data excellence and enhance the efficiency of our clinical research operations .Key Responsibilities:- Lead Data Management Initiatives:-Direct the ... Job DescriptionJob Overview:-We are seeking a highly qualified and experienced Associate Director in Data Management to lead our data management team in supporting… more
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleGenmab is searching for an experienced Director , Global Clinical Drug Supply to be part of Global ... at the forefront of bringing medicines to cancer patients and other serious diseases. Director , Global Clinical Drug Supply will work in partnership with several… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and optimization of organizational resource allocation. Relationships Reports into CDO Operations Director /Associate Director . Establish and manage ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...CDO & Novo Nordisk (eg, across CDO, CMR, International Operations (IO), HQ R&D, & Commercial). Supervisory responsibilities including… 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 ... ready to make a difference? The Position The Senior Director of CMR Knowledge & Technical Advancement (KTA) Department...serve to act as an advisor to North America Operations (NAO) CMR organization on all aspects of new… more
- Insmed Incorporated (San Diego, CA)
- … clinical development team, partnering closely with heads of clinical operations , toxicology, regulatory affairs, commercial, pharmacovigilance, clinical ... clinical studies.Medical monitoring, coding, and data cleaning in collaboration with Clinical Operations .Ensure the medical integrity of clinical study… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Coast Development Hub. Key internal stakeholders include Medical & Science, Clinical Operations , Regulatory Affairs, Data Management, Biostatistics, Non- ... 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… more
- Merck & Co. (Rahway, NJ)
- …integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory, Operations , Non- clinical , Clinical , and other functional ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …organization to guide enterprise-wide resource allocations, investment choices, drive core operations and develop insights to drive growth and operational excellence ... to maximize your potential with us? The Position As the Associate Director of Strategic Market Insights, the functional responsibilities include leading analyses of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Coast Development Hub. Key internal stakeholders include Medical & Science, Clinical Operations , Regulatory Affairs, Data Management, Biostatistics, Non- ... and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Coast Development Hub. Key internal stakeholders include Medical & Science, Clinical Operations , Regulatory Affairs, Data Management, Biostatistics, Non- ... 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… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …are crucial for this role. Advanced knowledge of Data Management, Biostatistics, Clinical Operations , Pharmacovigilance, handling and processing of raw data and ... areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a Quality by Design (QbD) and Risk-Based Quality Management (RBQM) approach to clinical trial conduct. Major focus is on operations concerning risk control ... Statistical Monitoring during study conduct to detect oddities, trends in clinical variables, or site differentials, following the critical variables defined during… more
- Merck & Co. (Rahway, NJ)
- …implementation of risk control measures.Analyze information from post-market surveillance, clinical evaluations, and real-world evidence to inform risk management ... of experience in pharmaceutical development, device development, device systems operations , quality management, or a related area.Strong knowledge of regulatory… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position SummaryThe Sr. Director of Technical Transfer is responsible for activities related to technology transfer from external and internal customers. This ... aspects of technical transfer including analytical transfer, development studies, clinical supplies, manufacturing scale up, equipment and process qualification,… more
