- Merck & Co. (Rahway, NJ)
- …focus on obesity and obesity-related metabolic disorders. - The Senior Director will manage the entire cycle of clinical development, including study ... analysis, regulatory reporting, and publication. - Specifically, the Senior Director may be responsible for Evaluating pre- clinical and translational work… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of managing multiple direct reports. Responsibilities:Operational Strategy:Align with the Head of Clinical Development Operations or Senior Director , ... centered around rare diseases and immune disorders. Job Summary: Senior clinical operational leader accountable for operational...of FIH, clin pharm patient studies, and Phases 1-3 clinical trials at the study and program… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Senior Director of CMR Knowledge & Technical Advancement (KTA) Department will serve to ... development, effective execution of CMR foundational and role-specific/technical training (eg clinical trial -related, GxP, Compliance, etc.) across the US and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization dedicated ... to the effective strategy, design, execution, and interpretation of Oncology clinical trials . Serves as a primary source of medical accountability and oversight… more
- Merck & Co. (Rahway, NJ)
- …medicines. Our company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will manage the ... monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible ForEvaluating pre- clinical and translational… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …actual product Responsible for all areas related to patient safety in clinical trials Act as member of the trial safety group for dose escalation decisions ... ECs, DMCs, and Academia. L ine management responsibility of Director /Associate Director Global Safety Lead, Senior...) Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and provide comments to trial outlines/protocols for Novo Nordisk-sponsored clinical trials Review proposals for investigator-sponsored studies (ISS) and ... National Leaders/National Expert Panels for select clinical trials , in collaboration with Clinical Director... Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director ,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …aspects of clinical trial management including execution of clinical trials from protocol finalization through closeout. Relationships Reports to: ... difference? The Position We are looking to hire a Senior Clinical Project Manager (CPM). This is...assist with periodic audit of the TMF Drive critical clinical trial activities including trial … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …application of those principles to trial design, planning & conduct of clinical trials In-depth knowledge & direct experience/interactions with the FDA (or ... external partners, identify, qualify, manage, and maintain relations with clinical trial sites, including collaboration with PIs...who contribute to the planning, conduct and reporting of clinical trials . Ensures business needs are met… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of the actual product Support all areas related to patient safety in clinical trials Act as member of the trial safety group for dose escalation decisions ... and external stakeholders. Relationships This position will report to Senior Director or Executive Director ...) Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... Planning and Execution: Provides input on major milestones of trial , clinical trial plan and...CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …application of those principles to trial design, planning & conduct of clinical trials In-depth knowledge & direct experience/interactions with the FDA (or ... the planning & successful delivery of studies within the clinical trial portfolio. Assists in creating, leading...external partners relevant to the design & implementation of clinical trials improvement/innovation projects for CDO &… more
- Merck & Co. (Rahway, NJ)
- …leader to drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be an experienced pharmacometrician with a ... QP2 efforts to strengthen our pharmacometrics capabilities on a continuous basis. The Senior Director will be accountable for directing a team of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Strong understanding of market needs and resource allocation Strong expertise in clinical trial methodology and conduct, and GCP principles Superior ... ready to make a difference? The Position The Strategy Director is a senior individual contributor role,...to improve working procedures, quality, and output. The Strategy Director serves as the clinical development strategy… more
- Genmab (Plainsboro, NJ)
- …play a pivotal role in ensuring the timely delivery of high-quality clinical trial supplies for both early and late-stage trials . In addition, this position ... our purpose.The Role & DepartmentGenmab is seeking an experienced Senior Clinical Drug Supply Manager to join...highly competent global team focused on packaging and labeling clinical trial supplies, collaborating closely with the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …analysis Leads development of a strategic insights plans in conjunction with Senior Director Enterprise Intelligence and incorporate market research and ... Market Research, secondary data analytics, searching and reviewing scientific literature, clinical trial data, journal studies Progressive demonstrated business… more
- Merck & Co. (Rahway, NJ)
- …areas regarding clinical issues related to oncology compounds.-The Executive Director , PDT Lead may:-Manage Directors and/or Senior Directors responsible for ... new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a Quality by Design (QbD) and Risk-Based Quality Management (RBQM) approach to clinical trial conduct. Major focus is on operations concerning risk control ... Statistical Monitoring during study conduct to detect oddities, trends in clinical variables, or site differentials, following the critical variables defined during… more
- Genmab (Plainsboro, NJ)
- …position is hybrid based in Princeton NJ (US) and will report to the Senior Director Global Access and Pricing. ResponsibilitiesLead the development of Global ... be our best, and authentic is essential to fulfilling our purpose.The RoleThe Director Global Market Access & Pricing Hematology will be responsible for developing… more
