- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and serving as the primary point of contact.Review and analyze data from clinical trials , post-marketing and other relevant sources for the prompt identification ... centered around rare diseases and immune disorders. Summary The Director , Clinical Safety, will be a product...signals. Review and evaluate serious adverse event reports from clinical trials or post-marketing for completeness, accuracy,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, ... trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study Team Leader for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …into the Global Clinical Operations VP and is accountable for ensuring the clinical trial portfolio and submissions are delivered to time, quality, and cost. ... in scope/portfolio.Close collaboration with Asset and Portfolio Management (APM), GCO Clinical Trial Business Operations (CTBO), and GCO Study Optimization… more
- Insmed Incorporated (Bridgewater, NJ)
- … development experience in the pharmaceutical/biotech Industry. Previous experience conducting clinical trials in Dermatology is a plusWorking knowledge of ... Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , Clinical Development will play an important role in working… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... leader (CSL)Study Planning and Execution: Provides input on major milestones of trial , clinical trial plan and contingency planning; Analyzes and updates… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …investigators is expectedThe CS Group Lead will also ensure the writing of high-quality clinical trial protocols, review of clinical data and Clinical ... Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical ...Senior Director level for each respective programThis Clinical Science (CS) Group Lead will be responsible for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of those principles to trial design, planning & conduct of clinical trials Deep understanding of Distributor, Logistics and Demand Planning Operations, ... This includes leading processes and technology improvements to link Clinical trial site needs, Finance and Supply...external partners relevant to the design & implementation of clinical trials improvement/innovation projects for NACD &… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in a timely fashion. In addition, the SD serves as a key member of the Clinical Trial Strategy Team, provides additional analytic support to the field team, and ... ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to...training initiatives for the medical affairs team Serve on Clinical Trial Strategy Team to identify investigators/sites… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …dedicated to the effective strategy, design, execution, and interpretation of Oncology clinical trials . Position Summary / Objective Serves as a primary ... source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in a timely fashion. In addition, the SD serves as a key member of the Clinical Trial Strategy Team, provides additional analytic support to the field team, and ... ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to...training initiatives for the medical affairs team Serve on Clinical Trial Strategy Team to identify investigators/sites… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …degree preferred A minimum of ten (10) years of progressively responsible clinical trial experience within a pharmaceutical, biotechnology, or CRO required, ... of FDA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required Demonstrates technical expertise within Clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …program in a specific indication, ie, multiple multinational phase II/III clinical trials ; Reviews regulatory documents from cross functional, holistic ... in regulatory agency meetings, if applicable; Defines study strategy across clinical trials within an indication or project; Attends EOP2 meeting and represents… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D ... and other internal stakeholders Perform or supervise regulatory review of all clinical and nonclinical documents for submissions, eg, clinical protocols and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pricing scenarios and strategy for all pipeline products starting in Phase II clinical trials . Generates insights to support G3 decision-making for the NASH ... aligned therapeutic / franchise area(s). Relationships Reports to the Senior Director of Value Communication and Contracting Strategy Interacts frequently in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Execution: As CSL for Phase 2 Studies: Provides input on major milestones of trial , clinical trial plan and contingency planning, Analyzes, updates ... trials of medium to high complexity in design and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory… more
- Tris Pharma (Monmouth Junction, NJ)
- …evaluation reports, etc.) Oversees reconciliation of safety data in pharmacovigilance and clinical trial databases Ensures audit and inspection readiness of Drug ... Study Reports (CSRs), etc.); Provides expert safety guidance to clinical trial project teams and/or external partners...and/or external partners to develop procedures and logistics for clinical trials Assists in preparation of response… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ensures quality delivery of all 3rd party data from diverse external providers for clinical trials , companion diagnostics trials , clinical development, ... and external data expertise to promote and implement best practices across the Clinical Trial lifecycle. Applies GCP principles to ensure all external data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in...a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …training and ensure effective implementation of SDTM, ADaM and TLFs standard in clinical trial data analysis- Develop and maintain necessary programming macros ... proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming preferred- 7 or More Years proven… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a proactive safety strategy for such candidates by the start of the FIH trial (DP1).- Clinical Development and Post Marketing: Consult with PSLs/GPTs on ... for accelerated development and approval with smaller numbers of subjects exposed, Clinical Safety and Pharmacovigilance (CSPV) must be embedded in R&D as early… more
