- Insmed Incorporated (Bridgewater, NJ)
- …Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , Clinical Project & Planning ... including ownership of Insmed's internal enrollment forecasting tool.Coordinates monthly Clinical Project Review meetings including scheduling, facilitation,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …one or more key functions (eg clinical research & development, clinical science, clinical quality assurance, project management) requiredStrong ... 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 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)
- …centered around rare diseases and immune disorders.SummaryThis position serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple ... surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s), and cross-functional team in support of benefit risk… 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)
- …are an equal opportunity employer including veterans and people with disabilitiesSummaryThe Associate Director , Global Oncology Clinical Development (GOCD) ... 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)
- …an equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing ... for all aspects of clinical pharmacology and biopharmaceutics studies; clinical pharmacology project lead; supports Phase 2/3 clinical … 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...functional areas (eg clinical research & development, clinical science, clinical quality assurance, project… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for patients who are likely to benefit from our therapeutics.ResponsibilitiesLeads CDx project teams for the diagnostic, in full alignment with Global Program Teams ... and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Position Manage and oversee all assigned projects/products/processes. Assist the Director / Associate Director in assuring Novo Nordisk compliance ... regulatory agencies. Supervise designated personnel. Relationships Report to the Director / Associate Director /Lead Regulatory Scientist/Sr. Manager Regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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 ... and standards. This position ensures quality delivery of medical coding for clinical trials, clinical development, and regulatory submissions. Develops and… 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 ... Quantitative Clinical Pharmacology (QCP) group to develop and apply QSP...address prioritization across the portfolio within Oncology/Immuno-OncologyCollaborate with multidisciplinary project teams to develop and apply QSP models to… 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, ... activities with functional groups within Daiichi Sankyo, Inc. related to assigned products/ project areas such as the clinical supplies organization, Reg… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Leads (GRLs). This position may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages ... those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.SummaryThe Associate Director (AD) is responsible for overseeing all activities ... TA including at all PMRT meetings and through ad hoc meetings with project owners. Partner with colleagues responsible for PGC medical review to ensure seamless… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This position works independently in simpler studies/models and interacts with internal project teams. Responsibilities Analyzes and presents MS Analyses of Phase 1 ... MS study reports for Phase 1 to 3 studiesInteracts effectively on internal project teams as well as independently in simpler studies/modelsWorks with and influences… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and best practices as well as strong technical skills in working with ( clinical ) data. The position holder will require strong skills in continuous improvement, ... project management, change management and risk management.Responsibilities ...statistics role supporting drug development and/or post marketing in clinical research, pharmaceutical, CRO or medical device setting required-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …time and within budget. The position may also collaborate with CROs ( Clinical Research Organizations) and manage oversight. The position will partner with internal ... SAS and R. The position will require proven skills in continuous improvement, project management, change management, and risk management. The position will act as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …improvements and seeks agreement through consensus management. Relationships Reports to an Associate Director / Director within the NNI Procurement ... Data & Analytics, Logistics & Distribution, Patient Support Solutions, Clinical Operations Pharmaceutical industry experience helpful, but not required Ability… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …excellence in managing multiple complex and competing priorities simultaneously. Proven project management and strategy skills. Is experienced in leading complex ... preferred Experience- 7 or More Years Outsourcing, health sciences or related field ( clinical trials) required- 7 or More Years Deep experience in pharma procurement… more
