- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …stud(ies).Ensures trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… more
- Merck & Co. (Rahway, NJ)
- …the Quantitative Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical ... of drug development and effective communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will work closely with teams… more
- Merck & Co. (Rahway, NJ)
- … Principal Scientist - Device Engineering and Early Development Lead ( Associate Director Equivalent)Our company's Device Development (DD) Team designs, ... device development team(s) supporting individual drug assets currently in clinical development with line of sight to commercial filing...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Merck & Co. (Rahway, NJ)
- …reliance on automation within Biologics Process Research & Development (BPR&D).The Associate Director role-will provide process automation leadership within the ... to onboard new technologies, facilitate tech transfer, and ensure efficient operations . Communication, organization, and solid controls experience will be critical… more
- Merck & Co. (Rahway, NJ)
- … Research Director ) as needed.Works in partnership with GCTO (Global Clinical Trial Operations ) country operations , finance, regulatory affairs, ... Job DescriptionWith support of Sr CRA/CRA Clinical Research Associate ) and/or CRA Manager,...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Merck & Co. (Rahway, NJ)
- …Research Director ) as needed.-Works in partnership with GCTO (Global Clinical Trial Operations ) country operations , finance, regulatory ... Job DescriptionWith support of Sr CRA ( Clinical Research Associate ) and/or CRA Manager,...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Merck & Co. (Rahway, NJ)
- …of decision-making at our company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate ... on a continuous basis in decision making and driving pipeline impact. The Associate Director will perform job duties independently with minimal supervision… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant ... medical topics, and supports PV Operations ' medical review function. This position supports a senior...board eligibility preferred Experience Qualifications1 or More Years of clinical experience preferred Daiichi Sankyo, Inc. is an equal… 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. ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Merck & Co. (Rahway, NJ)
- …innovation and improve lives. -Position Description: Under the guidance of the Oncology Clinical Development Finance Associate Director , the Finance Senior ... and analytical support to our Research & Development Division Oncology Clinical DevelopmentForecast grant spend as well as provide financial support related… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction ... of the Senior Director , GMA Oncology (Global Medical Affairs team lead for...drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the ... MSA discussions of external vendors by engaging with key cross-functional stakeholders ( Clinical Operations , Clinical Biomarkers, Precision Medicine, etc.)… 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 sucessful implementation of CDx and data collectionSupports Regulatory affairs in providing content and providing review of documents supporting CDx submissions to the FDA and other health authorities globallyCreates a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Manager role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This ... performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for...relevant experience is required with a BSc required.Experience in clinical operations methods and processes in industry… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …this position is accountable for partnering with the Global Team and Global Clinical leader to ensure effective team operations through meeting management, ... of these objectives. This position will report to the Sr. Director , Group Leader, GPM&L. Responsibilities Project Responsibilities: Independently manage and drive… 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. ... to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs, and other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data ... and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes… more
- Sunrise Systems Inc (Summit, NJ)
- …perform any other job-related duties as requested by management. Reports to Associate Director , Manufacturing Science & Technology (MSAT), Cell Therapy Specific ... located in Summit, NJ. Work scope will include commercial manufacturing and clinical manufacturing for all cell therapy products manufactured in Summit, NJ. This… more
- Elevance Health (Iselin, NJ)
- ** Clinical Operations Associate Medical Director ** **Neurosurgery** **Carelon Insights/Carelon Medical Benefits Management** _A proud member of the ... domains, including radiology, cardiology and oncology._ The ** Clinical Operations Associate Medical Director of Neurosurgery** responsible for performing… more
- Elevance Health (New York, NY)
- ** Clinical Operations Associate Medical Director ** **Carelon Medical Benefit Management** **Interventional Pain Benefit Review** **Location** : This ... set of clinical domains, including radiology, cardiology and oncology._ The ** Clinical Operations Medical Director ** is responsible for supporting the… more
