- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for ... improvement opportunities.Communicate and reinforce content and interpretation of Daiichi Sankyo's Clinical Data Standards to DS Project and Study teams,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study Team Leader for the assigned ... and immune disorders.SummaryThe incumbent will be responsible for ensuring execution of clinical studies across geographic regions, in adherence to Good … more
- Merck & Co. (North Wales, PA)
- …Summary This position drives scientific planning, strategy and execution of Phase 1-4 clinical studies . Under the direction of the Program Lead, you will ... of clinical data/medical protocol deviations in collaboration with the Clinical Director .Builds talent and capabilities of direct/indirect team members… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …manage GCO Risk Management Plans (RMPs) (design, management, and maintenance) for global clinical trials.Provide day-to-day support to study teams and their line ... into metrics to help track and oversee the progress of clinical trial risks at both a study and aggregate level to monitor and evaluate risks/issues across GCO… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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 ... development of minimum core product safety requirements for inclusion in Clinical study protocols (CSPs) and Informed Consent Forms (ICFs), for assigned… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies , conduct hands on population PK and PKPD analyses and ... an equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …role is primarily a tactical study delivery role, reporting into an Associate Director or above responsible for Operational Study Strategy. ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic...the timeline, budget and objectives set forth by the Study team.The Clinical Study Manager… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic... trial performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Functional Expertise:Serves as a subject matter expert in medical codingReviews/approves clinical study related documents pertaining to medical coding and ... Position manages the end-to-end delivery of medical coding data for assigned projects/ studies collaborating with clinical and medical teams, CROs and other… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle...safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in… more
- Merck & Co. (Rahway, NJ)
- …ensures continuity of site relationships through all-phases of the trial.Performs clinical study site management/monitoring activities in compliance with ... Job DescriptionWith support of Sr CRA ( Clinical Research Associate ) and/or CRA Manager,...site contact and site manager-throughout all phases of a clinical research study , taking responsibility of allocated… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Phase 1 to 3 studies , simulate multiple dose scenarios, and write M&S study report for Phase 1 to 3 studies . This position demonstrates general knowledge ... of Phase 1 studies and multiple dose scenarios, PK/PD M&S analysis data...of disease progression using relatively simple disease modelsWrites MS study reports for Phase 1 to 3 studiesInteracts effectively… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction ... of the Senior Director , GMA Oncology (Global Medical Affairs team lead for...as medical lead for select company-sponsored GMA evidence generating studies /projects. Manages all medical aspects such as study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …- Responsible, with limited supervision, for study activities assigned, eg for a clinical study : provide input on the development of study protocol ... The position will act as main statistical contact for the assigned studies , in particular in cross-functional Study team(s).Responsibilities- Study … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director , Quantitative Systems Pharmacology (QSP) will work within the ... into systems (disease) modelsContribute to the design, execution and interpretation of clinical and non- clinical studies .Partner with external groups to… 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 ... cell-based therapies. We are seeking an experienced and dynamic Associate Director to lead our in vivo...to drive the successful translation of preclinical findings into clinical applications. Your expertise will be critical in advancing… more
- Merck & Co. (North Wales, PA)
- …post-licensure). The Director will manage the entire cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory ... safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipating in...manage clinical development projects; andAssist the Senior Director , Executive Director , and/or Associate … more
- Merck & Co. (Rahway, NJ)
- …to join the Quantitative Pharmacology and Pharmacometrics - Immune/Oncology team in the role of Associate Director . The team is part of the Global Clinical ... of drug development and effective communication skills. As a subject matter expert, the Associate Director within the Group will work closely with teams of… more
- Merck & Co. (Rahway, NJ)
- …on clinical trial execution.Escalates site performance issues to CRM and Clinical Research Director CRD.People and Resource Management:Manage CRA - career ... will be key to ensure strong monitoring in our clinical trials. Under the oversight of the CRD or...a team of 6-14 CRAs and to ensure excellent study and site performance with strict adherence to local… more
- Insmed Incorporated (Bridgewater, NJ)
- …organizations etc.) to build and to execute the bioanalytical strategy specific to clinical development programs.Participate in clinical study design and ... bioanalytical methods and sample analyses of regulated bioanalytical assays for clinical , nonclinical and biomarkers studies . This translational role resides… more
