- Merck & Co. (Rahway, NJ)
- …team members including clinical directors and study managers to lead/support clinical trial scientific activities in the Atherosclerosis & Metabolism TA.Job ... of clinical protocol(s). Serves as the lead clinical scientist on the clinical trial...clinical data/medical protocol deviations in collaboration with the Clinical Director .Builds talent and capabilities of direct/indirect… more
- Insmed Incorporated (San Diego, CA)
- …programs including monitoring of clinical studies, review & interpretation of clinical trial data, authoring clinical study and regulatory communications ... manuals in a cross-functional team.Supporting or preparing data interpretation and clinical trial reports.Preparing Investigator Alert letters and SAE reports… 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
- Merck & Co. (Rahway, NJ)
- … clinical development strategies for investigational or marketed drugs Planning clinical trials (design, operational plans, settings) based on these ... on obesity and obesity-related metabolic disorders. - The Senior Director will manage the entire cycle of clinical...Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed drugs… more
- Merck & Co. (North Wales, PA)
- …DescriptionThis position leads the scientific planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will ... execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on the clinical trial team.Leading medical monitoring… 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 ... 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. (Bernards, 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …an RNAi platform. You will be responsible for the successful execution of clinical trials from protocol finalization through closeout. Relationships Reports to: ... assist with periodic audit of the TMF Drive critical clinical trial activities including trial ...and site startup and vendor management Experience in complex clinical trials preferred Ability to deal with… more
- Merck & Co. (Rahway, NJ)
- … clinical development strategies for investigational or marketed Oncology drugsPlanning clinical trials (design, operational plans, settings) based on these ... medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage...strategiesMonitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Oncology… more
- Genmab (Plainsboro, NJ)
- …synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reportsCoordinate data transfers from/to business partners ... RoleThe Associate Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both early and… more
- Merck & Co. (Rahway, NJ)
- …translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial design simulation, disease progression models, ... and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications… more
- Merck & Co. (Rahway, NJ)
- …or more novel quantitative approaches that seek to improve cycle time, cost/size, number of trials , clinical trial design and Go/No Go decisionsServe as a ... pharmacokinetics (PK) and pharmacodynamics (PD) analysis, model-based meta analysis (MBMA), clinical trial simulations (CTS), disease progression modeling and… more
- Daiichi Sankyo, Inc. (Bernards, 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …dedicated to the effective strategy, design, execution, and interpretation of Oncology clinical trials . Serves as a primary source of medical accountability ... and oversight for one or more clinical trials Matrix management responsibilities across the...input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …non- clinical and clinical factors, diagnosis, effective management during clinical trials and beyond in post approval setting.Responsible for the ... CSPV and other internal groups) and outside of Daiichi Sankyo (eg clinical trial sites, CROs, collaboration partners); Supports effective direct communication… 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 ... external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key...) Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial … more
- Merck & Co. (San Diego, CA)
- …public data resources, to generate novel CDx models that can be deployed in clinical trials . You will also support preparation of regulatory documents in support ... of clinical trials .- In addition, you will be...of clinical trials .- In addition, you will be the site lead...serve as a strategic partner to our discovery and clinical colleagues and will shape data science and AI/ML… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …governing clinical trials preferredUnderstanding and experience with end-to-end clinical trial processes and functions including experience in one or ... Director , Development SOP Management Join a Legacy of...functional cohesiveness across SOPs and related documents related to clinical trial execution.Responsibilities:Development SOP Landscape Develop and… more
- Genmab (Plainsboro, NJ)
- …and execution of Phase 3b/4 Medical Affairs led interventional and observational clinical trials ; Ensures US market needs are satisfied within Integrated ... part of our expanding US Medical Affairs (USMA) team, Genmab is seeking a Senior Director , USMA Solid Tumor Portfolio. This role will report to the VP/Head of US… more
- Merck & Co. (Rahway, NJ)
- …development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process ... Development (SMAR&D) group has an exciting opportunity for a Director role as GxP Strategic Lead based in Rahway,...methodologies to characterize and release raw materials, package components, clinical drug substance, and clinical drug product… more
