- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilitiesSummaryThe Associate Director , Global Oncology Clinical Development (GOCD) Functional ... generation (checklist, process map, etc.), change management and detailed analysesThe Associate Director , GOCD Functional Excellence must have excellent verbal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for the development , maintenance, and enforcement ... pipeline.Proactively identify Data Standards gaps and resolve issues related to clinical data standards development throughout the trial lifecycle.Standardize… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in end-to-end clinical trial execution in one or more key functions (eg clinical research & development , clinical science, clinical quality ... areas centered around rare diseases and immune disorders. Summary The AD, Global Clinical Operations (GCO) Clinical Trial Operational Risk (CTOR), will be… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an advanced degree required.6-9 years of experience with a bachelor's degree required. Clinical development or post-marketing experience to be able to apprehend ... (SAPs) and statistical outputs (tables, figures, and listings [TFLs]), and other clinical study documentsAuthors or oversees the development of safety sections… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …stud(ies).Ensures trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing ... & Simulation plans from FIH to post registration. Responsibilities include the development of Clinical Pharmacology and Modeling and Simulation plans, design… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , Global Clinical Operations (GCO) Procedural Ownership ... policies, and meet applicable ICH and GCP standards. The Associate Director will also be responsible for...experience in one or more key functional areas (eg clinical research & development , clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(CDx) in support of projects within Daiichi Sankyo's Early and Late Stage Development Portfolio. The individual will play a key role in making Precision Medicine ... Teams (GPT) for the therapeutic, covering all areas from CDx assay development through CDx approval and launchLeads CDx Partner evaluation and selection activities… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within ... of clinical trials is required Demonstrates technical expertise within Clinical Development , Medical Affairs, and Regulatory Affairs (CMR), staying… 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 ... therapeutic compounds. This includes working with scientists in Research, Translational Science, Clinical Development , in addition to colleagues in QCP. QSP… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and standards. This position ensures quality delivery of medical coding for clinical trials, clinical development , and regulatory submissions. Develops ... end-to-end delivery of medical coding data for assigned projects/studies collaborating with clinical and medical teams, CROs and other vendors to ensure high quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, ... Manufacturing and Controls) activities from early development to post-approval phase for biological, Cell and Gene Therapy, small molecule, Vaccines, and/or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …increased complexity including post marketing projects and those involving 3rd party development . This position partners with GRLs and Clinical Safety ... may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU....may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.Ensure… 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...a specific compound or indication. Responsibilities Support GMA the development of the Global Medical Affairs strategy and execution… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. Job Summary: The Global Brand Associate Director is accountable for supporting the development , integration, and execution of ... provided to cross-functional teams including but not limited to product clinical development team(s), HEOR, PRA, medical affairs, manufacturing and PR. This… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director Immuno-Oncology as part of the Research and Development ... of developing innovative cell-based therapies. We are seeking an experienced and dynamic Associate Director to lead our in vivo CAR-T cell therapy program.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in data science / business intelligence / statistics role supporting drug development and/or post marketing in clinical research, pharmaceutical, CRO or ... end-to-end delivery of AI/ML projects (from business understanding, over hands-on development to dissemination), to ensure high quality deliverables are on time… 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 (design, ... Qualifications- At least 5 years of experience as statistician supporting drug development and/or post marketing in Clinical research, Pharmaceutical company,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …industry, vendor base, and regulatory issues for respective categories. Leads the development of sourcing strategy for respective categories. Builds and maintains a ... vendor base. Manages vendor relationships. Implement sourcing and value development roadmap and initiatives; contribute to strong supplier relationship management,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …all phases of drug development , including early and late phase clinical development and submission preferred- Solid background in applied statistics ... to support submission QAs, perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting-… more
