- Eisai, Inc (Nutley, NJ)
- …and must have the experience and conviction to provide sound input on Clinical Pharmacology activities to a variety of project teams. Essential Functions ... at least 5 years of pharmaceutical industry related experience as a Clinical Pharmacology Project Lead.A thorough understanding of global regulatory requirements… more
- Merck & Co. (Rahway, NJ)
- …Principal Scientist can also be responsible for several effectiveness studies within a project , participating as the clinical representative in project teams ... and/or PhD whose primary function is to design, coordinate, monitor, and report clinical laboratory and field studies that will support the regulatory approval of… more
- Formation Bio (New York, NY)
- …responsibility you will provide strategic input to and monitor the execution of clinical studies as a project physician.Your ability to understand and navigate ... than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other ... centered around rare diseases and immune disorders. Job Summary: The Sr. Director, Clinical Safety MD, will lead the development and implementation of integrated … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and updates Study Supply Plans in close communication with CSO project Management Lead.Responsible for the Clinical Label Development process ... Experience Qualifications: 7 or More Years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development.… more
- Insmed Incorporated (San Diego, CA)
- …diseasesPrior experience serving as the regulatory lead on cross functional teams (CMC, clinical and project teams)Ability and experience in the development and ... to cross-functional teams and senior leadership, as neededCollaborate with Clinical Development, Clinical Operations, CMC, QA/QC, Nonclinical, Program… more
- Insmed Incorporated (NJ)
- …Development, Quality Assurance, and Regulatory, with input from Commercial, Research, and Clinical .Prepare and manage detailed project plans and drive them to ... in. Are you?About the Role:Reporting to the Director of Technical Operations, Project Management this position will be responsible for leading life-cycle management… more
- Merck & Co. (Rahway, NJ)
- …analyses.--8. Prepares oral and written reports to effectively communicate results of clinical trials to the project team, Management, regulatory agencies, or ... management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/ III trials.- The knowledge must be… more
- Insmed Incorporated (NJ)
- …understanding of advanced statistical concepts and techniques applicable to Clinical Research.Excellent project management, interpersonal and communication ... Director of Biostatistics is responsible for the statistical aspects for complex clinical trial(s) or indication product line. This role leads the protocol… 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 ... and deliverables in collaboration with diagnostic partner across all clinical trials within the project , including the timely deployment of CDx assays that are… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including feasibility, functional excellence, recruitment and retention, patient voice and clinical trial diversity. The leader may also strategize and establish ... and external stakeholders and ensure successful delivery of the clinical studies.Responsibilities:Guide strategy and delivery of GCO Functional Excellence. Shape… more
- Merck & Co. (Rahway, NJ)
- …Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed medicines in the ... area. Our company's Atherosclerosis & Metabolism medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will… more
- Genmab (NJ)
- …Then we would love to have you join us!The RoleThe Senior Manager, Clinical Programming is responsible for the establishment, governance, and integrity of Study Data ... implementation of future strategies and technology-enabled processes and tools for clinical trials standards, change control management and the exchange of standards… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …4 or More Years related professional experience required.Must have professional experience Project Management, Clinical Supply Management, and/or Clinical ... by senior staff, playing a supportive role in ensuring adherence to Project objectives, budget control and departmental collaborations. Work is escalated if outside… more
- Insmed Incorporated (NJ)
- …understanding of advanced statistical concepts and techniques applicable to clinical research.Strong project management, interpersonal and communication ... advancement of innovative statistical methodologies.Hands-on experience in designing and analyzing clinical trial data, with proficiency in SDTM and ADaM datasets… 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 ... 505(b)(2) applications. This role involves strategic leadership in clinical trials, clinical sciences, medical monitoring, target product profile (TPP)… 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
- Merck & Co. (North Wales, PA)
- …a program leader.Must possess familiarity with statistical analysis methods and clinical data management concepts; strong project management skills;Excellent ... statistical programming activities for multiple and/or large/complex late-stage drug/vaccine clinical development projects.Develop and execute statistical analysis and reporting… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of multiple myeloma.Legend Biotech is seeking a Strategic Initiatives & Capacity Expansion Project Manager as part of the Technical Operations team based in Raritan, ... NJ. Role OverviewThis position will be responsible for providing project lead support for strategic initiatives and capacity expansion activities at the cGMP … 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
