- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical ... in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage...clinical development strategies for investigational drugs and planning clinical trials (design, operational plans, settings) based… more
- Tris Pharma (Monmouth Junction, NJ)
- …and team success.We have an immediate opening in our Monmouth Junction, NJ location for a Senior Director , Clinical Operations.The Senior Director , ... quality-by-design in trial oversight and risk management across outsourced clinical trials , ensuring efficient issue resolution, risk mitigation and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , ... of FIH, clin pharm patient studies, and Phases 1-3 clinical trials at the study and program...start up, and monitor the overall agreed budget against trial progress. Work closely with internal and external stakeholders… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …program in a specific indication, ie, multiple multinational phase II/III clinical trials ; Reviews regulatory documents from cross functional, holistic ... and participate in regulatory agency meetings, if applicable; Defines study strategy across clinical trials within an indication or project; Attends EOP2 meeting… more
- Merck & Co. (Rahway, NJ)
- …analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible For:Evaluating pre- clinical and translational ... study of marketed compounds. In executing these duties, theThe Senior Director may:Supervise the activities of Clinical Scientists in the execution of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and provide comments to trial outlines/protocols for Novo Nordisk-sponsored clinical trials Review proposals for investigator-sponsored studies (ISS) and ... National Leaders/National Expert Panels for select clinical trials , in collaboration with Clinical Director... Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director ,… 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 ... 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
- Eisai, Inc (NJ)
- …Essential Functions Oversee outsourcing requirements for phase I-IV global clinical trials including functional services.Accountable for vendor management; ... 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of those principles to trial design, planning & conduct of clinical trials Deep understanding of Distributor, Logistics and Demand Planning Operations, ... This includes leading processes and technology improvements to link Clinical trial site needs, Finance and Supply...external partners relevant to the design & implementation of clinical trials improvement/innovation projects for NACD &… more
- Eisai, Inc (Nutley, NJ)
- …plan. Provide strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for ... for assigned therapeutic area. Under the direction of the Senior Medical Director , this role will be...Medical Affairs role. Clinical research experience, including conducting clinical trials in the Phase IIIb-IV area.… more
- Eisai, Inc (NJ)
- … provides strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for products ... in-house Medical Affairs role; MD preferredClinical research experience, including conducting clinical trials in the Phase IIIb-IV area.Expertise in… 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
- 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 ... Planning and Execution: Provides input on major milestones of trial , clinical trial plan and...CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL… more
- Merck & Co. (Rahway, NJ)
- …biopharma research, such as public Omics databases (eg, GenBank, GEO), clinical trial repositories (eg, ClinicalTrials.gov), patient-level data platforms (eg, ... Biotechnology, Cell-Based Assays, Cell Biology, Cell Physiology, Chemical Biology, Clinical Trials , Computer Science, Data Architecture, Data Integration,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as early as possible. This led us to create the Translational Patient Safety Senior Director position, which will have unique exposure to Daiichi Sankyo's global ... a first, preliminary benefit/risk assessment and make available to senior leadership at DP0. Surface expert knowledge on safety...for such candidates by the start of the FIH trial (DP1).- Clinical Development and Post Marketing:… more
- Merck & Co. (Rahway, NJ)
- …and manufacturing to manage clinical development projects; andAssist the Senior /Executive Director in ensuring that appropriate Corporate personnel are ... clinical development strategies for investigational or marketed Oncology drugs;Planning clinical trials (design, operational plans, settings) based on these … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …business, and other functional groups across NN. External relationships can include clinical trial sites and external vendors. Essential Functions Develop and ... quality concerns. Relationships This position reports to the Associate Director of GXP Oversight and/or Head of GXP Support....or resolve, for example across various topics, such as clinical trial management, deviation handling, and product… more
- Merck & Co. (Rahway, NJ)
- …leadership. Contribute to the business development strategy within biomarker discovery, clinical trial needs and Companion Diagnostic/Diagnostic programs in ... Job Description Position Description: Director , Business Development - Enabling Technologies Search and...conjunction with functional and clinical development leadership. Responsible for… more
- Merck & Co. (North Wales, PA)
- Job DescriptionReports to the Director / Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for ... for anticipated promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates to the use of… 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 ... centered around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, and analytic support… more
