- 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 ... performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for...years of relevant experience. required Experience Qualifications Experience in clinical operations methods and processes in industry… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head ... all therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable for...and to create value for patients and the healthcare system .Responsible for maintaining high level of visibility of operational… 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...with our Company IT leadership to develop a long-term systems and capability strategy and to prioritize DSCS Digital… more
- 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)
- …role of Associate Director . The 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
- 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 ... management of API/Intermediate/RSM manufacturing operations at Insmed's CMOs including tech transfer, process optimization, clinical /commercial manufacturing,… more
- Merck & Co. (Rahway, NJ)
- …work to design, install, and qualify new equipment to support GMP clinical production. -Execute and develop appropriate system validation, change control, ... on automation within Biologics Process Research & Development (BPR&D).The Associate Director role-will provide process automation leadership within the BDC Pilot… more
- Merck & Co. (Rahway, NJ)
- …and mentoring to the CTCs, as well as for interns-delegated to the Clinical Operations team based on the Internship program, while-properly managing situations ... and procedures and-with quality standards internally and externally.Under the oversight of the CRD( Clinical Research Director ) / Director , Clinical … more
- Merck & Co. (Rahway, NJ)
- …to support the Animal Health division. The position reports to the Director , our company's Outcomes Research.Position objectives: To inform and contribute to the ... value evidence strategy and associated studies which describe clinical , economic, and patient-centered unmet needs and the value the product provides in addressing… more
- Merck & Co. (North Wales, PA)
- …in organization development and building a new team.Reporting to the Executive Director of CMC Integrated Project Management, the core responsibility of this ... to manage the Vaccines portfolio of products within CIPM. In addition, the Director will be expected to mentor/coach Project Managers (PMs) (through direct and… 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. (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
- Eisai, Inc (Nutley, NJ)
- …in helping to shape and drive oncology pipeline advancement by coordinating with Clinical Development and Clinical Operations . Essential Functions Work with ... this is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics… more
- Catalent (Philadelphia, PA)
- …review and approval for instruments, equipment, and systems used in GXP Operations throughout the system life cycle. Other duties as assigned.The Candidate: ... Position: Director QualityLocation: Philadelphia, PAPosition Summary: The Quality function...build, monitor, and sustain a robust and effective quality system that delivers reliable, high-quality products that meet all… 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
- 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
- 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
- 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
- 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, acts as...information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.Supports audit/inspection activities as… 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, acts as primary site contact and site manager-throughout all phases of a … more
