- Bristol Myers Squibb (Princeton, NJ)
- …personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Senior Director of Clinical Quality Audit strategy is responsible ... of critical quality risks and issues that may affect BMS. The Senior Director , Clinical Quality Audit strategy is also responsible for effectively… more
- Novo Nordisk (Plainsboro, NJ)
- …changing lives for a living. Are you ready to make a difference? The Position Senior , Clinical Informatics leads the functions in the Clinical Data Science ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...leadership team and oversees NNI due diligence and other senior level oversight associated with the role + Internal/external… more
- Novo Nordisk (Plainsboro, NJ)
- …from either academia or industry. In this role, the Senior International Medical Director will be the medical lead for clinical development of projects in ... within the therapeutic area, including PRO and biomarker strategies. Relationships Reports to: Senior Director of the Liver Disease department. Work with the … more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …projects through early and late phase development. The Director reports to the Senior Director Clinical Sciences and collaborates closely with Medical ... The Director Clinical Sciences, Hematology, leads in...and independently supports the development of regulatory documents; performs quality review and/or approval; adjudicates and resolve cross functional… more
- Novo Nordisk (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 ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....study team, external service providers (CROs, vendors, etc.) and clinical sites to ensure all trial deliverables are met… more
- Novo Nordisk (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Senior Director of CMR Knowledge & Technical Advancement (KTA) Department will serve to ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...strategy they will provide valuable support and consultation to Senior Leaders in the Line of Business. In this… more
- Sanofi Group (Bridgewater, NJ)
- …for patients and their families. Join our **Biostatistics Rare Diseases as Senior Statistical Project Leader ( Director )** and you'll provide statistical ... leadership, guidance, and strategic input for clinical studies in one or more project teams. You'll...with other statistics project leaders, and in communicating with senior leadership. + Mentor junior project team members and… more
- Bausch Health (Bridgewater, NJ)
- …it-where your skills and values drive our collective progress and impact. As a Senior Director in Health Economics and Outcomes Research (HEOR), you will be ... strategic plans for asset candidates, including studies on burden of illness, real-world clinical outcomes, epidemiology, quality of care, and unmet needs. +… more
- Bristol Myers Squibb (Princeton, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . **Summary:** The Senior Director of Risk Diligence and Oversight will play a ... mindset and the ability to influence and collaborate with senior stakeholders across the organization. **Key Responsibilities:** **Healthcare Compliance Risk… more
- Bristol Myers Squibb (Princeton, NJ)
- …Development Plan for the disease/indication team + Manages and supervises a team of senior and junior Clinical Scientists to execute trial level activities for ... at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Clinical Science Lead reports through the Clinical Science function which… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. ... is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management… 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 ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …the execution of diversity and inclusion strategy and tactics for global clinical trial programs. + Accountable for the co-creation and implementation of diversity ... and technologies that will ensure delivery of diverse participant populations in clinical trials representative of populations anticipated to be treated with the… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …Clinical Trial Data Process Excellence and Delivery based remotely reporting to the Senior Director , Integrated Clinical Trial Data Process Excellence and ... Process Excellence and Delivery supports the strategy to develop and maintain quality Global Integrated Clinical Trial Data Services (GICTDS) function processes… more
- Bristol Myers Squibb (Princeton, NJ)
- …automated, efficient organization dedicated to achieving industry-leading medical quality , compliance, and cost effectiveness. Builds Medical Review capabilities ... abilities. Medical Review: Provides guidance regarding medical review of individual clinical trial and post-marketing reports. Oversees single case processing vendor… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …company to inspire you and empower you to shine? Join us as a ** Senior Manager, Clinical Partner Outsourcing** based remotely reporting to the Director ... innovative technology integration capabilities for best-in-class outsourcing management + As a senior member, work independently to oversee own portfolio of work, as… more
- Bristol Myers Squibb (Princeton, NJ)
- …personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Associate Director of Specialty Laboratory Vendor Quality will be mainly ... quality perspective and delivering the full range of quality . This role reports directly to the Director...systems, capabilities and performance + Supports the development of clinical laboratory Quality Agreements and the set-up… more
- Bristol Myers Squibb (Princeton, NJ)
- …project/products, to Health Authorities and RGO . + Translate risk factors into Clinical Quality Assurance oversight plans, including internal and external audit ... Medicine + Oversee the Data generation and data integrity from laboratory work and non- clinical phase projects + Ensure Quality is Designed into non- clinical … more
- Bristol Myers Squibb (Princeton, NJ)
- …writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality in collaboration with Medical Writing. Present to ... a ctivities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review .… more
- Bristol Myers Squibb (Princeton, NJ)
- …collecting all the relevant inputs from the RBM framework (CORM) as well as R&D Quality Clinical Quality Assurance on audits and inspections. * As part ... lives. Read more: careers.bms.com/working-with-us . Position Summary The Associate Director , RBQM - HOCT, ICN will mainly be responsible...with the CAPA CoE and Serious Breach pillar and Clinical Quality Assurance to gather input from… more