- Daiichi Sankyo, Inc. (Bernards, NJ)
- …submissions (IMPD/IND) Responsible to design the audit framework globally for Research area, specifically GLP/GCLP studies .Partners with Audit and Compliance ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.SUMMARYDevelop...the QA review and approval of GLP and GCLP study protocols, clinical study reports, ICFs, external… more
- Merck & Co. (North Wales, PA)
- …internal teams and external partners, design non-interventional and data synthesis studies , author study protocols, develop measurement questionnaires, case ... position resides within our company's Value and Implementation (V&I), Outcomes Research organization, which is responsible for real-world evidence generation and… more
- Tris Pharma (Monmouth Junction, NJ)
- Associate Director / Director , Analytical Research and DevelopmentMonmouth Junction, NJ Analytical Development, R&DDescriptionTris Pharma, Inc. ... Junction, NJ headquarters has an immediate need for an experienced Associate Director / Director , Analytical Research & Development. Job Title commensurate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical trial management, with firsthand experience managing collaborative research studies being highly desirable. Responsibilities:Lifecycle Management: ... (ICH) guidelines. This role emphasizes the management of Investigator Initiated Studies (IIS) and Collaborative External Sponsored Research (CESR) projects.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …leader for assigned compound under the supervision and leadership of the Executive Director of Medical Research and Strategy, US Oncology Medical Affairs ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary US Medical Affairs… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …(FDA) Good Laboratory Practice (GLP) Regulations. Under the general supervision of the Director , conducts contractual studies or research which is relatively ... OverviewResearch Scientist, Associates play a crucial role in managing preclinical research in all aspects of drug development as the single point of control… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of clinical development, including determination of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary The Senior ... Director sits within Global Oncology Clinical Development, an organization...and external network Manages Phase 1 - Phase 3 studies (depending on assignment) with demonstrated decision-making capabilities Provides… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryThe Senior ... Director sits within Global Oncology Clinical Development, an organization...and external network, Manages Phase 1 - Phase 3 studies (depending on assignment) with demonstrated decision-making capabilities. Provides… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …PIs to plan study and monitor completionStudy outputs: For Phase 2 studies : Drafts responses to IRBs and HA, Collaborates with TMCP to ensure appropriate ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Oversees one… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …committee setup; Interacts with KOLs and PIs to plan study and monitor completion. Study outputs: For Phase 2 studies : Drafts responses to IRBs and HA, ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: Oversees… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary Position leads complex studies in study design, statistical analysis and interpretation of results ... and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP development,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …interpret Phase 1 (specifically Clinical Pharmacology) studies , support Phase 2/3 studies , represent function on study and project teams, and participate in ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....Study Team Leader for Phase 1 Clinical Pharmacology studies , and provides clinical pharmacology input and support for… more
- Merck & Co. (Rahway, NJ)
- …the further study of marketed compounds.In executing these duties, the Director may:Supervise the activities of Clinical Scientists in the execution of clinical ... talented and dedicated colleagues while developing and expanding your career.-- Director (Principal Scientist) has primary responsibility for the planning and… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …or autoimmune disease. This includes designing and implementing in vivo pharmacology studies to support early-stage research programs and late-stage IND-enabling ... the treatment of multiple myeloma.Legend Biotech is seeking Associate Director of In Vivo Pharmacology as part of the...studiesInteract with and manage CROs for in vivo study related activitiesInteract and collaborate with research … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …development of Clinical Pharmacology and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies , conduct hands on ... opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing Clinical… more
- Merck & Co. (Rahway, NJ)
- …and dedicated colleagues while developing and expanding your career.The Senior Director (Senior Principal Scientist) has primary responsibility for the planning and ... directing clinical research activities involving new or marketed oncology medicines. Our...phases of clinical development (pre-clinical to post-licensure). The Senior Director will manage the entire cycle of clinical development,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …indications.Serve as medical lead for select company-sponsored GMA evidence generating studies /projects. Manages all medical aspects such as study document ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The … more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Associate Director Immuno-Oncology as part of the Research and Development team ... developing innovative cell-based therapies. We are seeking an experienced and dynamic Associate Director to lead our in vivo CAR-T cell therapy program. If you're… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Experience planning and conducting Medical Affairs interventional and non-interventional studies , including Ph 3b/4, EAP, externally sponsored research , ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryThe Director… more
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