- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study Team Leader for ... and immune disorders.SummaryThe incumbent will be responsible for ensuring execution of clinical studies across geographic regions, in adherence to Good Clinical … more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , Clinical Development will play an important role in working ... with the team to execute the global clinical development plans of brensocatib for the HSindication. Tasks...contact us directly to be considered for a formal agreement. Applications are accepted for 5 calendar days from the… more
- Merck & Co. (North Wales, PA)
- …of clinical data/medical protocol-deviations in collaboration with the Clinical Director .Builds talent and capabilities of direct/indirect team members ... drives scientific planning, strategy and execution of Phase 1-4 clinical studies.-Under the direction of the Program Lead, you...click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle...translational work for the purpose of generating the early clinical development plan and Investigational New Drug applications… more
- Merck & Co. (Rahway, NJ)
- …and procedures and-with quality standards internally and externally.Under the oversight of the CRD( Clinical Research Director ) / Director , Clinical ... role is accountable for execution and oversight of local operational clinical trial activities-in compliance with ICH/GCP and country regulations, company policies… more
- Merck & Co. (North Wales, PA)
- …globe. Working with the Asset Development Team (ADT's), early- & late-stage clinical development teams, the Biomarker (BMx) leads will develop asset-specific ... clinical biomarker strategy by incorporating critical insight from discovery...click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity… more
- Merck & Co. (Rahway, NJ)
- …and improve lives. -Position Description: Under the guidance of the Oncology Clinical Development Finance Associate Director , the Finance Senior Specialist ... and analytical support to our Research & Development Division Oncology Clinical DevelopmentForecast grant spend as well as provide financial support related… more
- Merck & Co. (Rahway, NJ)
- …to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development, and ... Clinical Supply across all modalities. We are interdependent across...click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity… 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 Scientific Director (SD) functions as a subject matter expert to...the SD serves as a key member of the Clinical Trial Strategy Team, provides additional analytic support to… more
- Eisai, Inc (Nutley, NJ)
- …to hear from you. Job Summary: As the Americas IT Security and Compliance Director , you play a pivotal role in ensuring the organization's adherence to security, ... Business Relationships:Promotes awareness of standards related to security, regulatory, clinical , commercial, and manufacturing processes to establish a culture of… more
- Merck & Co. (Rahway, NJ)
- …role of Associate Director . The team is part of the Global Clinical Development organization and has oversight over drug development aspects related to ... regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications (CTDs)), and representing our team at… more
- Merck & Co. (Rahway, NJ)
- …(include Requirements For Education, Experience And Skills)Job Description:The Associate Director Quality Assurance, Facilities, Validation & Automation will provide ... to international GMP requirements and applicable guidance for the production of clinical GMP drug substance, drug product and packaged goods across all modalities… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …related payment schedules) Advanced knowledge of regulatory and compliance requirements for clinical research, ICH GCP Principles and the application of those ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and… more
- Merck & Co. (Rahway, NJ)
- …regions simultaneously. Review and provide final approval Worldwide Marketing Applications , Clinical Study Reports, protocols, Confidential Investigator ... to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory strategy for their… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Director , Business Insights Analytics will be responsible for developing and communicating data-driven and actionable insights that drive greater ... strategy, population health, competitive insights, marketing operations, medical & clinical backgrounds. Develop and own commercial insight generation strategy and… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole Summary:The Global Senior Director Medical Affairs (GDMA) Immunology/Pipeline & Biomarkers will be responsible for driving execution of ... and regionsServes as an impactful member of Product Development Team sub-teams ( Clinical , Value Evidence, Commercial, Publications and Label) and Global Human Health… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …processes and standards. The position will have a strong knowledge of AI/ML applications and best practices as well as strong technical skills in working with ... ( clinical ) data. The position holder will require strong skills...statistics role supporting drug development and/or post marketing in clinical research, pharmaceutical, CRO or medical device setting required-… 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 Scientific Director (SD) functions as a subject matter expert to...the SD serves as a key member of the Clinical Trial Strategy Team, provides additional analytic support to… more
- Merck & Co. (South San Francisco, CA)
- Job DescriptionThe Executive Director of Cardiovascular (Cardio-renal disease & Heart Failure) will be responsible for overseeing and facilitating research in ... at a new state-of-the-art center in South San Francisco, CA. The Executive Director will contribute to the design, prioritization, and execution of the strategic… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewAssociate Director , Tech Ops (Process Chemistry) will have responsibility for the ... operations at Insmed's CMOs including tech transfer, process optimization, clinical /commercial manufacturing, process characterization and validation, and manufacturing CMC… more
