- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical ... Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle...percent of the time to manage future or ongoing clinical research projects. Qualifications Education MD, DO,… more
- Merck & Co. (Rahway, NJ)
- …(Sr. Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed Oncology medicines. ... medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will...percent of the time to manage future or ongoing clinical research projects. QualificationsMinimum education required: -… more
- Merck & Co. (Rahway, NJ)
- …(Principal Scientist) has primary responsibility for the planning and directing of clinical research activities involving new or marketed Oncology medicines. Our ... Oncologist or Uro-Oncologist specializing in bladder cancer Prior specific experience in clinical research and prior publication is desirable but not necessary… more
- Merck & Co. (Boston, MA)
- …opportunity for a physician-scientist to join our group as a- Principal Scientist ( Clinical Director ) in Translational Medicine/Early Clinical Development in ... should have a strong background in basic, translational, and/or clinical research and a desire to work...from the preclinical stage through Phase 1 studies of safety , tolerability, pharmacokinetics and pharmacodynamics, to Phase 2 studies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryThis position supports ... safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.SummaryThis position serves as the Clinical Safety Scientist Lead for a large, late-stage program or ... safety surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s), and cross-functional team in support of… more
- Insmed Incorporated (San Diego, CA)
- … clinical development in pharmaceutical/biotech industry, across multiple phases of clinical research (Phase 1-3)Knowledge of ICH-GCP and FDA regulatory ... for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Executive Medical Director of Ophthalmology, Clinical Development holds the responsibility… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Director , Clinical Development Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: Serves… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …related payment schedules) Advanced knowledge of regulatory and compliance requirements for clinical research , ICH GCP Principles and the application of those ... Clinical , medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring external-facing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to: VP, Medical & Science. Work with the VP Medical/Scientific Development, Clinical Operations, Non- Clinical Research , Medical Writing, Program Management, ... and international regulatory requirements Work with the VP Medical/Scientific Development, Clinical Operations, Non- Clinical Research , Medical Writing,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with key stakeholders within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs. Facilitate operational ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....(MedDRA, WHO-DD)- Knowledge of FDA and global PV regulations, clinical and safety databases- Familiarity with Good… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new ... indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and… more
- Genmab (Plainsboro, NJ)
- …fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for leading the development and maintenance ... will be within Global Regulatory Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be based in our Princeton,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key internal ... and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we... committees Participate as a member of the first safety committee chaired by non- clinical , where … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryThis position manages ... configuration and associated validation activities of Daiichi Sankyo Pharmacovigilance Safety systems, and fulfillment of data change requests. ResponsibilitiesChange… more
- Merck & Co. (North Wales, PA)
- …point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Develops worldwide product regulatory ... simultaneously.Reviews and provides final approval of Worldwide Marketing Applications, Clinical Study Reports, Protocols, Investigators Brochures before release from… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, ... trials from protocol finalization through closeout. Relationships Reports to: Director , Clinical Operations. Essential Functions Collaborate with internal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated ... to the effective strategy, design, execution, and interpretation of Oncology clinical trials. Position Summary / Objective Serves as a primary source of medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization dedicated ... of clinical sections of study-level documents (eg, protocol, amendments)Reviews safety data to mitigate risk to trial participants for the assigned trial… more
- Genmab (Plainsboro, NJ)
- …and in a compliant manner with colleagues in other functional areasEnsures optimal safety , clinical oversight and highest quality standards are applied to all ... part of our expanding US Medical Affairs (USMA) team, Genmab is seeking a Senior Director , USMA Solid Tumor Portfolio. This role will report to the VP/Head of US… more
