- Merck & Co. (Rahway, NJ)
- …the clinical /scientific execution of clinical protocol(s).Serves as the lead clinical scientist on the clinical trial team.Collaborates with the ... interpretation of clinical data/medical protocol-deviations in collaboration with the Clinical Director .Builds talent and capabilities of direct and indirect… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a primary source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external ... Director , Clinical Development Join a Legacy...input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Development. Internal relationships include working with Headquarters, NA CMR including Clinical Trial Management, Medical Affairs, Regulatory Affairs and other ... expert medical community input Regulatory liaison: Write and/or review clinical sections of clinical trial ...liaison: Write and/or review clinical sections of clinical trial reports, statistical reports, investigator's brochures,… 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
- Merck & Co. (Boston, MA)
- …opportunity for a physician-scientist to join our group as a- Principal Scientist ( Clinical Director ) in Translational Medicine/Early Clinical Development in ... biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations) for the design and execution of early … 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
- 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
- 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)
- …patients, sites, and caregivers With Director , serve as NACD SME on clinical trial diversity for local and global forums, initiatives, and communications ... clinical portfolio. Relationship This role reports into the Director of Clinical Research Equity supporting the...for the needs of diverse patient populations involved in clinical trials Analyze trial participant… 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
- 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
- Merck & Co. (North Wales, PA)
- … clinical development strategies for investigational or marketed Oncology drugs;Planning 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...strategies;Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Oncology… more
- Daiichi Sankyo, Inc. (Bernards, 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
- Merck & Co. (San Francisco, CA)
- …and retention efforts to achieve study milestones.Upon request from Global Clinical Trial Operations (GCTO),Recommends study sites and identifies potential ... Job DescriptionRole SummaryThe Cardiovascular & Metabolism Regional Medical Scientific Director is a credentialed (ie, PhD, PharmD, DNP, MD) therapeutic and disease… more
- Merck & Co. (Boston, MA)
- …and retention efforts to achieve study milestones.Upon request from Global Clinical Trial Operations (GCTO).Recommends study sites and identifies potential ... in the assigned territory (Boston area).Role SummaryThe Oncology Regional Medical Scientific Director - Head & Neck Cancers/Melanoma is a credentialed (ie, PhD,… 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. (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 ... advanced pharmacometrics capabilities like comparator modeling, model-based meta-analysis (MBMA) and clinical trial simulations (CTS) into programs and thereby… 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
- 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
