- Tris Pharma (Monmouth Junction, NJ)
- …success.We have an immediate opening in our Monmouth Junction, NJ location for a Senior Director , Clinical Operations .The Senior Director , Clinical ... development portfolio. The incumbent is accountable for the Clinical Operations cross functional collaboration to develop...but not limited to: Clinical Project Managers, Clinical Trial Managers, Clinical Data … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head ... study management and delivery for all therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable for ensuring the clinical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the resources within NACD. Relationships Reports to Snr Director of Clinical Strategy and Business Operations within Operational Excellence and Delivery ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ... to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …engaging with key cross-functional stakeholders ( Clinical Operations , Clinical Biomarkers, Precision Medicine, etc.) for establishing data collection, ... including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for...standard data collection practices preferred- 7+ years Clinical data management experience in a medical… more
- Insmed Incorporated (Bridgewater, NJ)
- …limited to, the following:Provides medical/scientific input and advice by working closely with Clinical Scientists and Clinical Operations personnel on ... in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , Clinical Development will play an important...EC/IRBs.Provide medical feedback for activities related to review of data for interim analysis or blinded data … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department At Novo Nordisk, our Finance and Operations team is the engine that elevates holistic commercialization of our products. The Finance and ... Operations team works closely with the business across the...in order to accomplish objectives. Relationships Reports to the Director , Patient Support Programs Rare Disease. Key internal relationships… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …up, model the way and enable the team to act.Provides medical leadership to- GMA clinical operations teams as part of evidence generation forums and study teams ... areas centered around rare diseases and immune disorders.Summary The Senior Director , Global Oncology Medical Affairs is responsible for developing the Global… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders.Provides support ... areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction of the Senior… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders. Provides ... research areas centered around rare diseases and immune disorders. Job Summary:The Director , Global Medical Affairs (GMA), Gyn Oncology, under the direction of the… more
- Merck & Co. (North Wales, PA)
- …least 2 years of experience in publication managementUnderstanding of the clinical development process andclinical study data for assigned ... Job DescriptionOverview:The Associate Director Publication (Pub) Manager is the central source...the selection of appropriate journals and congresses for scientific data dissemination. They work closely with both internal writing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …protocol timelines; considers relevant input and guidance to other areas within NACD including Operations Director and TA Heads End to End Supply Operations ... collaboration: Responsible for implementation of best practices and standards for clinical operations , including sharing lessons learned. Partner closely with… more
- Merck & Co. (Rahway, NJ)
- …products to produce safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate Director , is a subject matter ... for growth opportunitiesThe Vocabulary Specialist may lead or participate in:Internal clinical data standards forumsStandards development teams and data… more
- Eisai, Inc (Nutley, NJ)
- …in helping to shape and drive oncology pipeline advancement by coordinating with Clinical Development and Clinical Operations . Essential Functions Work with ... this is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics… more
- Merck & Co. (Rahway, NJ)
- …of the FLEx complex is shared across two co-leader roles, and includes operations that support end-to-end GMP clinical supply manufacture and product/process ... and reports to the Associate Vice President of Pharmaceutical Operations and Clinical Supply in our Research...digital capabilities that allow for better access to high-fidelity data , more efficient clinical product release, improved… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …scientific and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations , Clinical Leads ... and Regulatory Liasions to ensure successful implementation of CDx and data collection- Supports Regulatory affairs in providing content and providing review of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disciplines and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. ... and immune disorders. Summary Position manages the end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other… more
- Merck & Co. (South San Francisco, CA)
- Job DescriptionThe Director of Immuno-Metabolism will be responsible for overseeing and facilitating the research in metabolic disorders & inflammation, in the ... CMD strategy, including integration of new technology platforms, human biology, and data science, with a focus on uncovering novel biology in immuno-metabolism to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
- Merck & Co. (Rahway, NJ)
- …of, contractors performing various GMP activities supporting the production of clinical supplies with focus on drug product. Additionally, experience in medical ... conduct of contractor "deep dive" quality assessments such in data integrity and leading cross-functional contractor performance reviews as...your employment may pose an undue burden to business operations , in which case you may not be offered… more
