- Novo Nordisk Inc. (Plainsboro, NJ)
- …and execution of National Advisory Board meetings, at the discretion of Executive Director ) Deliver clinical data and other presentations at National ... for select clinical trials, in collaboration with Clinical Director and Clinical Operations...gain feedback from advisors Support other advisory boards with clinical data and other medical presentations Partner… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Novo Nordisk policies and procedures. Relationships This position reports to a Senior Director within the Clinical Data Science & Evidence (CDSE) - RWE ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- Job Title:Head of Clinical Data ManagementJob Grade:G6/G7Department:Biostatistics and Data ManagementFLSA Classification: Manager's Job Title:Head of ... Main responsibilities will include effective leadership, planning and oversight within the Clinical Data Management (CDM) function as well as facilitating… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- Job Title: Head of Clinical Data Management Job Grade: G6/G7 Department: Biostatistics and Data Management FLSA Classification: Manager's Job Title: Head of ... Main responsibilities will include effective leadership, planning and oversight within the Clinical Data Management (CDM) function as well as facilitating… more
- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, NJ facility for an experienced MD to serve as Senior Director or Director , Clinical Development. Title and salary commensurate with ... (CRO) and/or Medical Writer to contribute to drafting of clinical study reports and other reporting data documents; Participates in ongoing data reviews (ie,… more
- Tris Pharma (Monmouth Junction, NJ)
- …an experienced MD with expertise in the Pain therapeutic area to serve as Senior or Executive Medical Director . Title and salary commensurate with experience. ... The Executive/ Senior Medical Director provides leadership, direction and medical...company pain programDirects and oversees analysis and interpretation of clinical trial data and clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization dedicated ... in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review PlanAccountable for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment ... Coordinates clinical activities across the project; Represents IPT to Sr . ManagementAdditional non-study related activities: Provides input on KEE selection for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated ... UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) review- Conducts clinical data review per Integrated Data Review Plan- Accountable for the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …this role, the incumbent will help develop multiple products. In doing so, the Senior Medical Director will work across different functional teams to support the ... industry experience, including time managing clinical trials, or academic clinical research background Working knowledge of biostatistics, data management, … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Director Global Medical Affairs Oncology (GMA), under the direction of the Senior Director , GMA Oncology (Global Medical Affairs team lead for compound), is ... for the assigned GMA plan activities, in collaboration with Sr Director .Support medical readiness activities for market...and other scientific exchange activities in alignment with the Senior Director , such as scientific symposium and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …, Global Medical Affairs (GMA), Gyn Oncology, under the direction of the Senior Director , GMA Oncology (Global Medical Affairs team lead for compound), ... budgets and resources for the assigned GMA plan activities, in collaboration with Sr Director .- Leads medical readiness activities for market launches and life… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …indications; Interacts with our Discovery and Research programs for development of early clinical studies. Provides senior level clinical representation at ... senior management of CRO, as needed; Accountable for clinical development plans, protocol profiles and sections of key...Study Lead (CSL)- Clinical Surveillance: Documents ongoing Clinical Monitoring review of data for safety… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or More Years Minimum 7 years' experience in life sciences, pharma with Clinical Trials Operational Data , Clinical Operational Metrics and Milestones. ... required4 or More Years Experience in working with CRO data for execution of large global clinical ...to end execution. preferredDemonstrated ability to influence at all senior organizational levels through clear, concise, and impactful verbal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Analytics functions and translating into business impact. Relationships Reports to the Senior Director , Enterprise Functions Insights Lead with direct management ... managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference? The Position The Novo Nordisk Real World Evidence (RWE) / Clinical Data Science & Evidence (CDSE) - Fellow is responsible for supporting ... & budget management. Relationships The Fellow reports to a Senior Director RWE and works closely with...with all colleagues in both the RWE and broader Clinical Data Science & Evidence (CDSE) department.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...study team, external service providers (CROs, vendors, etc.) and clinical sites to ensure all trial deliverables are met… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and Clinical Study Report (CSR): Provides oversight of activities performed by ... relevant to project development plan, study design, statistical analysis, data display, results validation, interpretation and reporting to accelerate worldwide… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …within the Global Clinical Science function. This position may be at the executive director level or senior director level, depending on the scope and ... the writing of high quality clinical trial protocols, review of clinical data and Clinical Study Reports (CSRs)/outputs throughout the project life… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …abreast of and lead discussions as a functional expert on:- Newly available clinical data and promotional content within the assigned therapeutic area- ... research areas centered around rare diseases and immune disorders.SummaryThe Associate Director (AD) is responsible for overseeing all activities related to Medical… more
