- Eisai, Inc (NJ)
- …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 ... in MS Office Suite with a good understanding of other IT systems for contract management and clinical development.#LI-TS1Eisai Salary Transparency Language:The… more
- Merck & Co. (Rahway, NJ)
- …on automation within Biologics Process Research & Development (BPR&D).The Associate Director role-will provide process automation leadership within the BDC Pilot ... 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)
- …small molecule drug substance pilot plant facility, owning the automation control systems , delivering API for clinical supplies, providing process knowledge for ... technical and operational excellence in a pilot plant facility, including scale-up, operations , knowledge of regulatory and quality systems , capital planning,… more
- Merck & Co. (Rahway, NJ)
- …role of Associate Director QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to ... including translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial simulation, disease progression models, quantitative systems… more
- Merck & Co. (Rahway, NJ)
- …US Health Systems , Global Clinical Development (GCD), Global Clinical Trial Operations (GCTO), Global Medical and Value Capabilities (GMVC), Outcomes ... Job DescriptionThe Executive Director for Cardiovascular & Metabolism (ED CVM) within...and research support.Optimizes and ensures therapeutic support of Health Systems accounts by fostering collaboration with the Medical Affairs… more
- Merck & Co. (North Wales, PA)
- …& Division organization of our company.- Position Description/Summary: The GPAM Associate Director , Project Manager, is a core member of Early Drug Development ... & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive cross-functional… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Director , Global Market Access, Immunology T he Director , Global Market Access, Immunology will play a leadership role in ... strategy for assets within our Immunology portfolio. In this role, the Director will lead the development and execution of global market access strategy,… more
- Merck & Co. (Rahway, NJ)
- …according to quality, compliance and timeliness requirements; expertise in SAS and clinical trial programming, systems and databases including advanced knowledge ... and vaccine programs.Interact with cross functional scientists including, Statistics, Clinical , Regulatory, QP2, CSRM, Data Management and Statistical Programming to… 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 Maryland. ... to the Vice President and General Manager, the Senior Director Supply Chain directs all facets of supply chain...and financial costing. This includes the deployment of common systems , improved processes and advanced technology to drive continuous… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …MSA discussions of external vendors by engaging with key cross-functional stakeholders ( Clinical Operations , Clinical Biomarkers, Precision Medicine, etc.) ... (eg, CRO); oncology, immunology, or complex disease required- 7+ years working knowledge of Clinical trial data systems and/or EDC lab management tools is a plus… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director , Global Clinical Operations (GCO) Functional Excellence (FxExc), ... status. In addition, this role will support the FxExc Director in leading innovation and optimization by gathering industry...metrics and trend analysis to key stakeholders in Global Clinical Operations and GDO Leadership, as appropriate.… more
- Catalent (Philadelphia, PA)
- …and Computer System Validation documentation review and approval for instruments, equipment, and systems used in GXP Operations throughout the system life cycle. ... Position: Director QualityLocation: Philadelphia, PAPosition Summary: The Quality function...leadership and Quality Management support within each of the Clinical development supply division. This individual will have responsibility… more
- Tris Pharma (Monmouth Junction, NJ)
- …success.We have an immediate opening in our Monmouth Junction, NJ facility for a Director , Drug Safety. The Director , Drug Safety is responsible for planning, ... management planning. The incumbent works cross-functionally with counterparts/teams in Clinical Development, Regulatory Affairs, Manufacturing, Quality, etc. to identify,… more
- Insmed Incorporated (Bridgewater, NJ)
- …related issues.Collaborate with multiple internal and external stakeholders (therapeutic areas, clinical pharmacology, clinical operations , non- clinical ... for Millennials™ lists.OverviewWithin the Translational Bioanalytical Sciences (TBS) group of Clinical Development, the role focuses on LC-MS/MS of small and large… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …interacts, and provides direction to, information technology, Commercial Effectiveness, Clinical Operations and Marketing Effectiveness. Strong collaborations ... Agreement (CIA)) regulatory requirements (eg PDMA reporting) and the systems that support these processes (eg the transparency system)....with senior leaders from Legal, Finance, Operations and Market Access as well as others across… 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)
- …in related discipline, or equivalent work experience required.8+ years' experience in clinical operations CRA capacity required.5+ years' experience in proven ... and establish a well-connected network with other Early/Late Leaders and Clinical Operations Leadership required.Demonstrated ability in influencing others in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the respective clinical programs.Help to ensure in collaboration with Global Development Operations (GDO) (Global Clinical Operations / Clinical ... working and new technologies.Lead Lessons learned information flow at the GPT/ Clinical Operations level based on audits, inspections, regulatory intelligence,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. Summary The Manager, Global Clinical Operations (GCO) Functional Excellence (FxExc), will help support and ... status. In addition, this role will support the FxExc Director in lead innovation and optimization by gathering industry...including experience in one or more key functions (eg, clinical research, clinical operations , data… more
- George Washington University (Washington, DC)
- …in the GW School of Medicine and Health Sciences is seeking an Assistant Director , Business Operations Clinical Research, SMHS. This position manages all ... Assistant Director reports to the Chief of Clinical Research Administration and Operations , and Chief...with and tracks milestone progress in agreed upon tracking systems in real time. Collaborates with internal and external… more
