- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study Team ... 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)
- …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
- Merck & Co. (Rahway, NJ)
- …role is accountable for execution and oversight of local operational clinical trial activities-in compliance with ICH/GCP and country regulations, ... Clinical Research, the individual is responsible to-manage/oversee a team of CTCs( Clinical Trial Coordinator).As line manager the role is critical to… 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)
- …innovation and improve lives. -Position Description: Under the guidance of the Oncology Clinical Development Finance Associate Director , the Finance Senior ... the Global Project Manager, Alliance Manager, Global Trial Manager, Clinical Sub Team, Clinical Trial Team, Outsourced Trial Team, and Partnerships,… more
- Merck & Co. (Rahway, NJ)
- …more novel quantitative approaches that seek to improve cycle time, cost/size, number of trials , clinical trial design and Go/No Go decisionsFraming critical ... of decision-making at our company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the ... all 3rd party data from diverse external providers for clinical trials , companion diagnostics trials ,...expertise to promote and implement best practices across the Clinical Trial lifecycle. Applies GCP principles to… 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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Manager role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This ... and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and...share with study team, Operations Program Lead, and Sr. Director for the compound, on regular basis and ensure… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …preferred Experience- 7 or More Years Outsourcing, health sciences or related field ( clinical trials ) required- 7 or More Years Deep experience in pharma ... & category management required- CRO experience preferred- Strong knowledge of clinical trials preferred- Demonstrated ability to leverage digital data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Oncology Value Access & Pricing will both develop ... oncology asset(s). This person will report to the Sr Director , Global Oncology Value Pricing & Access, and will...its impact on pricing & access preferred- Knowledge of clinical trial designs; sound understanding of … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, ... study findings through presentations and/or publications in peer-reviewed scientific journalsAssess clinical trial and/or other data sources to contextualize… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …comprehensive Data Management expertise to promote best practices across the Clinical Trial lifecycle.Qualifications: Successful candidates will be able to ... and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. This position… more
- Insmed Incorporated (Bridgewater, NJ)
- …assays (eg M10 Bioanalytical Method Validation).Familiarity and experience in establishing clinical biomarker analyses for clinical trials .Strong ... for Millennials™ lists.OverviewWithin the Translational Bioanalytical Sciences (TBS) group of Clinical Development, the role focuses on LC-MS/MS of small and large… 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
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director of Biostatistics is responsible for the statistical ... aspects for complex clinical trial (s) or indication product line. This...section development, study setup, execution, analysis, and reporting of clinical trials , and interacts with cross-functional teams.ResponsibilitiesAdditional… 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)
- …organization, domain, function and role perspective. This person will report to the Associate Director , Training and Communication of the Center for Data ... of experience in life sciences, pharma or informatics industry working with clinical trials , genomics / biomarkers, discovery, commercial, real world data.-… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to seek alignment and share resources across multiple groups. Relationships Reports to Associate Director or above within CMR Training & Knowledge Management. ... is preferred A minimum of eight (8) years of progressively responsible clinical development/ trial experience within a pharmaceutical, biotechnology, or CRO… more
