- 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 ... program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective;… more
- Merck & Co. (Rahway, NJ)
- …within GCTO, especially with Clinical Sciences and Study Management (CSSM), Clinical Quality Managers (CQMs).Engage with Functional Service Provider (FSP) ... in our headquarters. Additionally, there are important interactions with, inter alia, Quality Assurance, Finance, Regulatory, Clinical Supplies and legal in a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study… more
- Catalent (Harman, WV)
- Senior Director , Supply Chain Position Summary: The Senior Director , Supply Chain is responsible for leading the supply chain organization for Catalent ... online.Reporting to the Vice President and General Manager, the Senior Director Supply Chain directs all facets...committed to a Patient First culture through excellence in quality and compliance, and to the safety of every… more
- Eisai, Inc (NJ)
- …provider business relationships in alignment with global strategies.Review and approve Clinical Quality Assurance audit plans and reports.Review and respond ... this is your profile, we want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support activities related to… more
- Merck & Co. (North Wales, PA)
- …clinical data/medical protocol deviations in collaborations with the Clinical Director .Other responsibilities include: Collaborating cross-functionally in the ... protocol in collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Leaders/National Expert Panels for select clinical trials, in collaboration with Clinical Director and Clinical Operations lead Support investigator ... (KOLs), Healthcare Professionals (HCPs), and other stakeholders. The Medical Director will also assist the Senior Medical... Clinical Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director ,… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , ... into CDP planning and individual protocols to facilitate successful implementation of programs. Clinical OperationsEnsure high quality delivery of all studies for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …TMCP to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment ... program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective;… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director for Cardiovascular & Metabolism (ED CVM) within US Medical Affairs (USMA) will lead the USMA field medical (FM) teams ... FM teams.Responsibilities and Primary ActivitiesLeadership and ManagementServes as a senior leader in the USMA organization, broadly influencing medical activities… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Senior Manager/Associate Director , External Manufacture as part of the Global ... position will be responsible for managing the technical transfer and clinical /commercial manufacture of cell therapy products in our external manufacture… 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
- Catalent (Manassas, VA)
- Senior Quality Auditor Position Summary: Catalent...with site and Suppliers to finalize to allow Supplier Quality Director approval Act as a liaison ... safety of every patient, consumer and Catalent employee. The Senior Quality Auditor will be responsible for...sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director of Field Medical Excellence (FME) will develop field medical functional ... strategy to enable high- quality , impactful customer engagements with a consistent approach worldwide....customer engagements with a consistent approach worldwide. The FME Director will also drive operational excellence across the regions.… more
- Insmed Incorporated (Bridgewater, NJ)
- …for Millennials™ lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of Pharmacovigilance QA ... serves as a strategic partner managing quality and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and other related activities performed by… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … programs.Help to ensure in collaboration with Global Development Operations (GDO) (Global Clinical Operations / Clinical Quality Management or other RD ... Development Leadership teams, as appropriate and as neededInteract with senior Oncology Franchise leadership teams to ensure Quality...and reviewing quality metrics for the Quarterly Quality Report (QQR) and Clinical Quality… more
- Merck & Co. (Rahway, NJ)
- …and clinical development leadership. Responsible for leading deep scientific and clinical due diligence, the quality of formal due diligence output, ... Job Description Position Description: Director , Business Development - Enabling Technologies Search and Evaluation Job The Search and Evaluation (S&E) team is a core… more
- Merck & Co. (Rahway, NJ)
- …and provide insights into implementation of strategic direction.In support of the Senior Director , Operations and Reference Data Management, ensures project ... Data Management, Global Clinical Data Standards Working closely with the Global Clinical Data Standards (GCDS) Sr. Director of Operations and Reference Data… 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 ... focus on uncovering novel biology in immuno-metabolism to deliver a high- quality drug discovery pipeline.We are a research-driven biopharmaceutical company. -Our… more
