- Tris Pharma (Monmouth Junction, NJ)
- …personnel selection including, but not limited to: Clinical Project Managers, Clinical Trial Managers, Clinical Data Managers, Regulatory Managers, ... in our Monmouth Junction, NJ location for a Senior Director , Clinical Operations.The Senior Director ,...the organization and by applying overall and specific project management and organizational leadership expertise to the clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …standards, (v) encouraging innovation.Build strong relationships with clinical development, clinical sciences, regulatory, biostats, data management , and ... research areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … management of the resources within NACD. Relationships Reports to Snr Director of Clinical Strategy and Business Operations within Operational Excellence and ... 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)
- …and SDTM and industry standard data collection practices preferred- 7+ years Clinical data management experience in a medical device, pharmaceutical ... including veterans and people with disabilities. Summary The Associate Director , External Data Management , is...7+ years working knowledge of Clinical trial data systems and/or EDC lab management tools… more
- Eisai, Inc (Nutley, NJ)
- …responsibilities.Ensures the timely and appropriate collection, organization, and analysis of diverse data sources (eg, clinical trial data , patient ... programs/tools to facilitate the statistical analysis of biomedical or related data .Demonstrated excellence in complex project management , showcasing the ability… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment ... Represents clinical function at meetings with health authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior leadership… more
- Eisai, Inc (Nutley, NJ)
- …and Clinical Operations. Essential Functions Work with key stakeholders, management , and functional area leads to develop strategic and aligned Medical Affairs ... 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. (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
- Insmed Incorporated (Bridgewater, NJ)
- …statistical analysis. Collaborate with team in the development and implementation of Data Management activities including development of eCRFs, edit checks, ... Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , Clinical Development will play an important role in working… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in the assigned therapeutic area. Relationships Reports to the Executive Director - Clinical Research & Development. Internal relationships include working ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...with Headquarters, NA CMR including Clinical Trial Management , Medical Affairs, Regulatory Affairs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary Position manages the end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs ... drug development processes and global submissions. This position provides leadership within Data Management by partnering with internal and external stakeholders… more
- Merck & Co. (Rahway, NJ)
- …Co-Leads are responsible for creation and management of the performance management processes that govern operations, including tier, clinical siting and ... new digital capabilities that allow for better access to high-fidelity data , more efficient clinical product release, improved product/process characterization,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Director , Clinical Safety, will be a product safety lead or part of ... , and provide safety leadership including but not limited to clinical studies, post-marketing surveillance, signal detection and management , important… 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 ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… 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 ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...bespoke, evidence-based M&A advisory services. Reporting into the Executive Director of M&A Advisory, the Director , M&A… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Reports to Director or above within CMR Training & Knowledge Management . Collaborates with global and CMR leaders and stakeholders to develop, design, and ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …placement and delivery to US and CA warehouses operations for US and CA Clinical Trial sites. Accountable for overall performance management of Senior Supply ... a collaborative work culture, including direct partnership with the Operations Director (s) Stakeholder management : Build strong internal and external… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole Summary: The Oncology Regional Medical Scientific Director (RMSD) is a credentialed (ie, PhD, PharmD, DNP, MD) therapeutic and disease expert who ... policiesMaintains current knowledge and comprehension of dynamic scientific and clinical environment in the Company's Areas of Interest (AOI)Research: Upon… more
