- Merck & Co. (North Wales, PA)
- … lead the coordination and execution of major change projects across Global Clinical Trial Operations. The role will also assist with Program Management ... are being applied across initiatives. The incumbent may directly lead strategic efforts and/or lead or provide...are updated and readily available for internal teams and senior leaders. Upon completion of a project, the PMO… more
- Merck & Co. (Rahway, NJ)
- …in meetings with investigators and regulatory agencies in discussions about clinical trial issues and submission strategies.Ensures the statistical designs ... Involved in research activities for innovative statistical methods and applications in clinical trial development. Education and Minimum Requirement: PhD or… more
- Merck & Co. (Rahway, NJ)
- …and ensures continuity of site relationships through all-phases of the trial .-Performs clinical study site management/monitoring activities in compliance with ... site contact and site manager throughout all phases of a clinical research study,-taking overall responsibility of allocated sites.Actively develops and expands… more
- Merck & Co. (Rahway, NJ)
- …COM, Head COMs or CRD, the person is responsible for, execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready. The ... ownership in country and site informed consent documents.Implements and oversees clinical trial country submissions and approvals for assigned protocols.Develops… more
- Merck & Co. (North Wales, PA)
- …plans, preparation of status update reports, study closeout activities).- May serve as the clinical trial team (CTT) lead . -Leads team for timeline ... innovative medicine.Accountable for the operational planning, feasibility, and execution of a clinical protocol.- May lead team in key study planning,… more
- Merck & Co. (Rahway, NJ)
- …Lead research activities for innovative statistical methods and applications in clinical trial development.Collaborates in publication of research results in ... processing software eg SAS and/or R.-Solid understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V.-Excellent oral and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … drug development across projects Establish, implement, and proactively manage clinical trial processes, strategic outsourcing and performance indicators In ... Development organization this is a key new role to lead the Clinical Operations function across our...Clinical Operations line management experience Domestic and international clinical trial execution experience required Post-approval … more
- Merck & Co. (Rahway, NJ)
- …feasibility, and execution of a clinical trial .- May serve as the clinical trial team lead - May lead team in key study planning, development, and ... This position leads the operational planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... study leader (CSL)Study Planning and Execution: Provides input on major milestones of trial , clinical trial plan and contingency planning; Analyzes and… more
- Merck & Co. (Rahway, NJ)
- …biomarker models, quantitative system pharmacology (QSP) and disease progression models, clinical trial design via outcome/enrollment modeling and simulation, ... Relationship ManagementPreferred Skills:Biological Sciences, Biomedical Engineering, Biopharmaceuticals, Chemical Engineering, Clinical Medicine, Clinical Trial Designs,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Clinical Operations lead Support investigator meetings Serve on Clinical Trial Strategy Team in collaboration with Clinical Operations point, ... other stakeholders. The Medical Director will also assist the Senior Medical Director in the development and execution of...Medical Affairs team on relevant disease state topics and clinical trial data. Review and approve resources… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director, Clinical ... research areas centered around rare diseases and immune disorders.SummarySenior clinical operational leader accountable for operational planning and execution of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a proactive safety strategy for such candidates by the start of the FIH trial (DP1).- Clinical Development and Post Marketing: Consult with PSLs/GPTs on ... for accelerated development and approval with smaller numbers of subjects exposed, Clinical Safety and Pharmacovigilance (CSPV) must be embedded in R&D as early… more
- Eisai, Inc (Nutley, NJ)
- …provides strategic development, planning, implementation, and oversight of Phase IV clinical trial programs within the Medical Affairs department. She/He ... in helping to shape and drive oncology pipeline advancement by coordinating with Clinical Development and Clinical Operations. Essential Functions Work with key… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …all external information of the program, including publications, regulatory documents, clinical trial registers, data release, etc. Accountable for protecting ... immune disorders. Summary The Global Team Leader, is a senior , cross-functional leader in Daiichi Sankyo's Global R&D organization....In this key role, the candidate will have to lead a complex, global team in charge of a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Quality is consistently and proactively represented at program level and along the clinical trial process in support of a proactive quality risk management ... technologies. Lead Lessons learned information flow at the GPT/ Clinical Operations level based on audits, inspections, regulatory intelligence, effectiveness… more
- Merck & Co. (Rahway, NJ)
- …leadership. Contribute to the business development strategy within biomarker discovery, clinical trial needs and Companion Diagnostic/Diagnostic programs in ... conjunction with functional and clinical development leadership. Responsible for...the integration of internal subject matter expert input and senior management review and approval. Work closely with search… more
- Merck & Co. (Boston, MA)
- … pharmacology, biomarkers of target engagement, experimental medicine platforms, early clinical trial designs and conduct, and operational understanding for ... and own Immunology strategy with other TA Heads (Discovery/Late-Stage Clinical Development). Lead key technical reviews for Immunology assets.Conduct… more
- Novo Nordisk Inc. (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 ... and field alignment directors. They will also be the senior strategic representative of medical affairs in the relevant...clear direction on Medical Affiars engagement needs to the clinical data science & evidence team and other relevant… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study findings through presentations and/or publications in peer-reviewed scientific journalsAssess clinical trial and/or other data sources to contextualize ... analysis of epidemiologic studies, including real-word evidence (RWE), supporting senior management in various epidemiological activities.This position independently carries… more
