- Daiichi Sankyo, Inc. (Bernards, NJ)
- …when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution ... with Clinical Scientists (CS)Interpretation and presentation of clinical study (ies) data to internal and external...and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Clinical Development in Project Teams, possibly as Global Clinical Lead . ResponsibilitiesStudy Strategy: Clinical study leader (CSL) or major ... studies : Provides input on major milestones of trial, clinical trial plan and contingency planning, Analyzes, updates management...updates; Responsible for valid clinical interpretation of study results as Clinical Study … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical supplies across the DSI portfolio. This role as CSO ( Clinical Supply Planning and Operations) Project Lead is primarily responsible for ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....rare diseases and immune disorders. Summary NOTE: This Project Lead Role is an Individual Contributor and sits at… more
- Merck & Co. (Upper Gwynedd, PA)
- …degree preferred.Required Experience and Skills:Minimum of 6 years of relevant experience in clinical research , including at least 2 years of direct experience ... clinical trials conducted worldwide. In collaboration with the Clinical Quality Operations Lead {CQOL and Head...Quality Assurance (QA) and acting as the link between Clinical Development, study teams, global business functions… more
- Insmed Incorporated (San Diego, CA)
- …including monitoring of clinical studies , review & interpretation of clinical trial data, authoring clinical study and regulatory communications and ... Medical Director of Ophthalmology, Clinical Development holds the responsibility to lead clinical programs across different diseases and supervise the … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oversight.Manage and/ or guide the QA review and approval of GLP and GCLP study protocols, clinical study reports, ICFs, external publications, and ... submissions (IMPD/IND) Responsible to design the audit framework globally for Research area, specifically GLP/GCLP studies .Partners with Audit and Compliance… more
- Eisai, Inc (Nutley, NJ)
- …activities (feasibility, start-up, conduct and close-out) under the direction and supervision by study Clinical Operations Lead (s). Plans, support , creates, ... in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of...and communicates clinical study timelines. Gathers input from cross- functional teams and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …product(s) or clinical studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and build and review Statistical Analysis Plans (SAPs) and ... rare diseases and immune disorders.SummaryThis position serves as the Clinical Safety Scientist Lead for a large,...of minimum core product safety requirements for inclusion in Clinical study protocols (CSPs) and Informed Consent… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …data collection and analysis. Opportunities are also available to become involved in and/or lead research papers and publications. The majority of time will be ... well as knowledge of the principles, methods, and procedures of basic medical and/or clinical research . Must have the ability to understand and follow basic… more
- Merck & Co. (Rahway, NJ)
- …therapeutic area and encourage appropriate application of new methods to outcomes research studies . -Accountable for innovative and effective dissemination of ... affairs (GMSA) and other cross-functional teams. -Specifically, the executive director will lead a team of outcomes research professionals to develop value… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL) Study Planning and Execution: Provides ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Oversees typically… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …needed- Clinical Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of ... Clinical Scientists (CS)- Interpretation and presentation of clinical study (ies) data to internal and external...and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution ... with Clinical Scientists (CS)Interpretation and presentation of clinical study (ies) data to internal and external...and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of… 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, ... of all clinical and nonclinical documents for submissions, eg, clinical protocols and study reports, preclinical reports, investigator brochures, application… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Programs / Studies .- Serve as the subject matter expert for Study Data Managers during the planning/start-up, conduct and close-out of external data management ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Manager… more
- Merck & Co. (Rahway, NJ)
- …medicineSignificant research experience as lead clinical investigator, specifically experience with investigator-initiated studies , concept ... Affairs (EDSA) maximizes meaningful bi-directional scientific exchange with the worldwide clinical and academic community to positively impact Research and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Executes statistical activities for low ... such as nQuery, East, etc.Strong analytical and problem-solving skills.Some knowledge of pharmacology, clinical research , and medical terminology and use it for … more
- Merck & Co. (San Francisco, CA)
- …for approved, in-development, and active Company-sponsored trials and/or investigator-sponsored research studies . The Regional Medical Scientific Director serves ... from investigators and provides information regarding participation in Company-sponsored clinical studies .Scientific Congress SupportEngages in scientific congresses… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium ... and immune disorders. Summary Position leads statistical support for medium complexity studies including contributing to development of optimal study design,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....rare diseases and immune disorders. Summary Position leads complex studies in study design, statistical analysis and… more
