- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Job Summary: The Sr. Director, Clinical Safety MD, will lead the development and implementation of integrated project /product risk management ... a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Responsibilities:Develops and updates Study Supply Plans in close communication with CSO project Management Lead .Responsible for the Clinical Label ... updating relevant Trial Master Files (TMF) with CSO-related documents.Supports the CSO Project Mgmt Lead in executing additional operational and logistical… more
- Insmed Incorporated (NJ)
- …Clinical Operations timelinesFoster and manage strategic supplier relationships, lead vendor selection, performance monitoring, business review governance, and ... frameworks for both internal supply operations and external partnersServe as clinical supply representative on cross-functional project and clinical… more
- Insmed Incorporated (San Diego, CA)
- …experience serving as the regulatory lead on cross functional teams (CMC, clinical and project teams)Ability and experience in the development and execution ... you?About the Role:The Director, Regulatory Affairs will serve as the regulatory leader on cross-functional teams, where they will be responsible for guiding… more
- Insmed Incorporated (NJ)
- …and timely completion and hand-off to routine commercial manufacture.What You'll Do: Lead project teams for Technical Operations activities, both within Insmed ... and with external contractors. Lead the transition of projects from Research into Technical...Assurance, and Regulatory, with input from Commercial, Research, and Clinical .Prepare and manage detailed project plans and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …projects that definitively require a CDx for drug registration or for any project with CDPs containing multiple registrational clinical trials and are ... this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support...and deliverables in collaboration with diagnostic partner across all clinical trials within the project , including the… more
- Merck & Co. (Rahway, NJ)
- …designing and analyzing clinical trials and coordinating the statistical activities for clinical trial projects; and may lead a group of statistical or ... Lead a team of staff assigned to the project as needed.-This includes the following activities:1. Is involved...oral and written reports to effectively communicate results of clinical trials to the project team, Management,… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- OverviewThe Respiratory Clinical Development Medical Lead will oversee the clinical and medical aspects of new respiratory medicines, including new drug or ... medical/ clinical queries from health authorities. Leadership and Collaboration: Lead cross-functional teams in clinical development, medical affairs, and… more
- Insmed Incorporated (NJ)
- …of clinical trials, and interacts with cross-functional teams.What You'll Do: Lead complex clinical trials or indication corresponding to one or several ... understanding of advanced statistical concepts and techniques applicable to Clinical Research.Excellent project management, interpersonal and communication… more
- Merck & Co. (Rahway, NJ)
- …Molecule VCM Product Leader (PL) is the end-to-end (E2E) supply chain lead responsible for developing and executing product supply strategies for one or more ... ultimately affects access, continuity of supply, and commercial outcomes. The VCM Product Leader will lead the cross-functional Supply Chain Working Group (SCWG)… more
- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference ... --The Senior Director will report to an Associate Vice President in the Oncology Clinical Research Group. Under the guidance of a supervisor, the Senior Director has… more
- Merck & Co. (North Wales, PA)
- … leader .Must possess familiarity with statistical analysis methods and clinical data management concepts; strong project management skills;Excellent ... Job DescriptionPosition description:- Lead the statistical programming activities for multiple and/or large/complex late-stage drug/vaccine clinical development… more
- Eisai, Inc (Nutley, NJ)
- …through cross-functional teams, as well as budget planning & management.Significant project management experience leading multiple critical complex clinical ... If this is your profile, we want to hear from you. The Clinical Quality Assurance Professional (QAP) position is responsible for design, delivery and execution… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in Raritan, NJ. Role OverviewThis position will be responsible for providing project lead support for strategic initiatives and capacity expansion activities ... a manufacturing readiness strategy to deliver capacity ramp up to meet clinical and commercial demand.Drive capacity evaluations and lead action implementation… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …NJ. Role OverviewThis position will be responsible for providing operational excellence project management support to the cGMP Clinical and Commercial Cell ... project management in cross-functional drug development teams or clinical , regulatory, pharmaceutical sciences/technical operations in the biopharmaceutical industry.Excellent… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …decision-making. In doing so, he or she will align closely with the Global Project Team and Global Team Leader as well as counterparts overseeing research ... statistical analysis plans, and aid in the construction of clinical development plans, clinical protocols, and in...co- lead Advisory Panels at certain scientific conferences. Lead the Translational Subteam within the Global Project… more
- Merck & Co. (Rahway, NJ)
- …enables gain of critical internal experience during scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, training ... fast-paced job that provides a high degree of technical, project , and people management responsibility. - This SSO Facility..., and people management responsibility. - This SSO Facility Lead role within the SSO Pilot Plant leverages significant… more
- Insmed Incorporated (NJ)
- …Programming will be working interactively with functional colleagues from Biostatistics, Clinical Operations, Data Management and Project Management, as well ... the Role:The Manager, Programming will provide statistical programming and analytic support clinical studies. As a team member of the Programming function, the… more
- Merck & Co. (Rahway, NJ)
- …analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)A project leader ; completes tasks independently at a project ... be a key collaborator with modelers, statisticians and other project stakeholders.Primary Activities:Programmatically synthesize preclinical data into analysis ready… more
- Merck & Co. (North Wales, PA)
- …deliverables for Research & Development projects (data, analyses, tables, graphics, listings)A project leader ; completes tasks independently at a project ... This position supports statistical programming activities for late-stage drug/vaccine clinical development projects. This may include leadership of one or… more
